EVENTS

Please visit us at the following trade show events:

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71st AACC Annual Scientific Meeting & Clinical Lab Expo

4-8 August 2019| Anaheim Convention Center | Anaheim, CA, USA
Visit us at booth #3902

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MEDICA

18-21 November 2019 | Dusseldorf, Germany


Mesa Biotech to Introduce Expanded Molecular POC Testing Portfolio at the European Congress of Clinical Microbiology and Infectious Diseases SAN DIEGO, CA – April 9, 2019 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will demonstrate its expanded, novel Accula™ Test System at the 29th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). ECCMID is being held on April 13 – 16, 2019 in Amsterdam, Netherlands and the Accula System will be on exhibit in Booth 1.1C. Mesa Biotech has obtained CE Mark in the European Union (EU), as well as 501(k) clearance and CLIA Waiver from the U.S. Food and Drug Administration (FDA) on both its Accula Flu A/Flu B and RSV tests. The Accula System, recently named 2019 Frost & Sullivan Price/Performance Global Value Leader, is a palm-sized, reusable dock with disposable test cassettes. The novel molecular test system offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes to guide same day treatment decisions. Both the Accula Flu A/Flu B and RSV tests are indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient. “We are excited to introduce our expanded PCR test platform at ECCMID,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “As our product offerings continue to increase, we are carefully selecting additional strategic distributors to add to our growing international network.” About Mesa Biotech Inc. Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ System consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the US by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia. For more information visit http://www.mesabiotech.com. Contact Information Joleen Schultz Joleen@joleenschultzassociates.com Cell: 760-271-8150 http://www.mesabiotech.com.

Mesa Biotech to Introduce Expanded Molecular POC Testing Portfolio at the European Congress of Clinical Microbiology and Infectious Diseases SAN DIEGO, CA – March 19, 2019 – Mesa Biotech Inc., is a privately held, molecular diagnostic company that developed an affordable and easy to operate polymerase chain reaction (PCR) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis. Today, Mesa Biotech announced that it has been awarded Frost & Sullivan’s 2019 Price/Performance Value Leadership Award for Influenza Point-of-Care Testing; Global Market. The Frost & Sullivan Best Practices Award compared Mesa Biotech’s AcculaÔ System against competitor devices on key criteria such as functionality, ease of use, product/service quality, and performance reliability.

Download the Frost & Sullivan Price/Performance Research Report

“Mesa Biotech’s patented and patent-pending technology shifts the focus from expensive and centralized laboratory-based molecular DNA and RNA tests to decentralized and affordable POC test systems,” said Unmesh Lal, Program Manager at Frost & Sullivan. “Mesa’s Accula Flu A/Flu B is the only visually read molecular test in the market that offers the familiarity of a traditional immunoassay. Combining the sensitivity and specificity of PCR technology with rapid diagnosis in 30 minutes, a low price point, and lower operating costs, Mesa Biotech was the clear recipient of Frost & Sullivan’s 2019 Global Price/Performance Value Leadership Award in the influenza point-of-care testing market.”

“We are honored to receive this award recognizing the value and performance of the Accula Test System,” said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. “It has been our vision to create a technologically-advanced, PCR testing platform with an affordable price point at the POC, enabling physicians to provide better patient care.”

For distribution of Accula Flu A/Flu B tests, Mesa Biotech entered into a strategic alliance with Sekisui Diagnostics for exclusive product distribution rights in the United States under the SilarisÔ brand. Accula is also sold directly in Europe through a network of distribution partners.

Mesa is actively applying the Accula technology to other infectious disease segments and is expanding its product portfolio into women’s health, respiratory, and sexually transmitted disease markets with new assay introductions and platform enhancements.

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ System consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the US by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia. For more information visit http://www.mesabiotech.com.

Contact Information Joleen Schultz Joleen@joleenschultzassociates.com Cell: 760-271-8150 http://www.mesabiotech.com.

Accula RSV Test FDA Cleared for Both Children and Adults

SAN DIEGO, CA – November 27, 2018 – Mesa Biotech Inc., is a privately held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis. Today, Mesa Biotech announced that it received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its AcculaÔ RSV test. The respiratory syncytial virus or RSV test cassette is cleared for diagnosing both children and adult populations.

The Accula RSV test is the second molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, following the company’s Flu A/Flu B test, cleared earlier this year. The Center for Disease Control (CDC) acknowledges that the specificity and sensitivity of rapid influenza diagnostic tests (RIDT) are lower than for viral culture and RT-PCR and vary by test. The Accula molecular test system provides the superior sensitivity, specificity and information content of laboratory-based PCR testing, while offering the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, with its palm-sized, reusable dock and disposable test cassettes. Furthermore, the Accula RSV test is indicated for use with nasal swab collection, which is less invasive than nasopharyngeal swabs and provides a more comfortable specimen collection experience for the patient, especially children.

“The addition of Accula RSV test to our Flu A/Flu B test significantly enhances our upper respiratory rapid, molecular diagnostic offerings,” said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. “It is important to have a distinct in-office diagnosis for RSV and flu, especially in young children and the elderly to provide timely, accurate information to clinicians to ensure appropriate treatment and improved patient management.”

According to the CDC, young children and older adults are more likely to get serious complications if they get sick with RSV. Each year in the US, an estimated 57,000 children younger than five years old are hospitalized due to RSV infection. Additionally, it is estimated that more than 177,000 older adults are hospitalized and 14,000 of them die in the US due to RSV infection. Adults at the highest risk for severe RSV infection include those 65 years and older, adults with chronic heart or lung disease and/or adults with weakened immune systems.

For rapid distribution of both tests, Mesa Biotech entered into a strategic alliance with Sekisui Diagnostics for exclusive product distribution rights in the U.S. and Canada. The Accula RSV test, along with the company’s Flu A/Flu B test, is marketed by Sekisui Diagnostics under the Silaris brand.

About Respiratory Syncytial Virus

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula System consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA). Both products are distributed in the US and Canada by Sekisui Diagnostics under the SilarisÔ brand. Mesa Biotech has secured a number of strategic agreements for distribution in Europe and Asia. For more information visit http://www.mesabiotech.com.

Contact Information Joleen Schultz

Joleen@joleenschultzassociates.com

Cell: 760-271-8150

Mesa Biotech Obtains CE Mark for its Accula RSV Molecular Point of Care Test

 New Test Designed to Speed Accurate Diagnosis and Enhance Patient Experience

SAN DIEGO, CA – November 7, 2018 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC), today announced it has obtained CE Mark in the European Union (EU) for its AcculaÔ RSV Test. The company’s RSV test will be marketed by select distributors in the EU at once.

“We are excited to introduce the second test in our PCR-based infectious disease diagnostic portfolio in the EU,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “The Accula RSV brings reference laboratory performance to the point of care, enabling clinicians to quickly and accurately diagnosis and treat their patients.”

Respiratory syncytial virus (RSV) is an RNA virus attributable to outbreaks of respiratory tract infections. RSV infections can occur throughout the year, but typically peak during the winter months. Studies indicate that nearly 100 percent of children will suffer from RSV infections by age two. RSV viruses not only cause upper respiratory tract infections but also bronchiolitis of the lower respiratory tract, which often becomes severe in infants and toddlers with underlying diseases. Diagnosis of RSV is difficult because the initial symptoms can be similar to those caused by other infectious agents. Considering that the RSV virus is highly contagious, accurate diagnosis and prompt treatment of patients can have a positive effect on public health.

According to WHO, the global burden of RSV-associated acute lower respiratory infection is estimated at 33 million annually, resulting in more than 3 million hospitalizations and almost 60,000 in-hospital deaths in children under five years of age.

The FDA, CDC, and WHO acknowledge that existing POC immunodiagnostic tests perform poorly, therefore molecular testing is recommended. The Accula System, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. The Accula RSV test is indicated for use with nasal swab collection, which is less invasive than nasopharyngeal swabs and provides a more comfortable specimen collection experience for the patient, especially children.

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s AcculaSystem consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B Test, Mesa Biotech’s first product to market, has obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). For more information visit http://www.mesabiotech.com.

Mesa Biotech Provides Corporate Update
 Company Commercializes Accula System in EU and U.S. and Prepares for Expansion

SAN DIEGO, CA – July 26, 2018 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, provides an update on notable accomplishments and corporate priorities for the remainder of 2018.

“In 2017, we focused on preparing our AcculaÒ Test System for commercialization, strengthening key corporate partnerships that will build the foundation for our global distribution channel strategy, expanding manufacturing capacity, and building an experienced team. In the first half of 2018 we launched our first product in both the EU and US and secured additional funding to execute on our mid-term and long-term strategic plans,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “We are now positioned to further  expand manufacturing capacity and move our pipeline products forward.”

2017 and Early 2018 Highlights

2017 was a year of pre-commercial preparation for Mesa Biotech. To facilitate global expansion, the company received an internationally recognized ISO quality certification. This designation marked the completion of a critical step for commercialization of Mesa Biotech’s novel Accula System in the European Union (EU) and the United States (US).  The company hired Steven Sepulveda for the vital role of Vice President Global Business Development and Channel Management. Sepulveda is directing and overseeing all aspects of global commercial sales, business development, strategic alliances and distributor management.

Rounding out 2017, Sekisui Diagnostics became a strategic partner and exclusive distributor for Mesa Biotech products in the US and Canada, ensuring immediate access to established distribution in North America due to their market strength and excellent reputation among distributors and healthcare providers.

The first quarter of 2018 was pivotal for Mesa Biotech. The company obtained CE Mark in the EU for its Accula System. The first available test in the EU market was the company’s Flu A/Flu B Test.  Several weeks later, Mesa received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for their Accula Flu A/Flu B test.  The CLIA waiver is significant as it allows for use and commercialization in the wider segment of alternate care including the physician office lab (POL) market.

Mesa Biotech raised $20 million in a Series B financing round in early July, following a $3 million Series A financing from earlier in the year. These two rounds bring the company’s total year funding to $23 million, leaving Mesa debt free.

2018 Priorities

With a solid foundation, Mesa Biotech is well-positioned for continued progress in the second half of 2018. The company intends to invest recent funding in new assay development, increased production capacity, commercialization activities, facilities expansion and key hires.

“Unlike other available molecular POC products in the market, our Accula System has a low-cost entry point and operating cost, requires no calibration or refrigeration of components and minimal maintenance. These are significant benefits for a point of care clinician,” said Cai. “Our POC product solution offers thesimplicity, convenience and procedural familiarityof traditional rapid immunoassays; while delivering the excellent sensitivity, specificity and information of laboratory-based PCR testing.”

Near term, the company is planning to further develop its respiratory infectious disease product portfolio as well as expand into sexually transmitted diseases and women’s health. Mesa has completed the RSV (respiratory syncytial virus) assay clinical trial and expects to obtain CE Mark later this summer and launch in time for the EU’s RSV 2018-2019 season. In the US, a dual submission for 510(k) clearance and CLIA-waiver for the Accula RSV test has been submitted to the FDA.

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s AcculaSystem consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. For more information visit http://www.mesabiotech.com.

Mesa Biotech to Showcase New Molecular POC Testing Platform at the 2018 AACC Scientific Meeting

 SAN DIEGO, CA – July 18, 2018 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will showcase its novel AcculaFlu A/Flu B test at the 70th Annual American Association of Clinical Chemistry Scientific Meeting & Clinical Lab Expo (AACC).  AACC is being held on July 29 – August 2, 2018 at McCormick Place in Chicago, Illinois. The Accula System, which will be on exhibit in Booth 1878, obtained CE mark in the European Union (EU), as well as 501(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA) earlier this year.

“We are excited to be a part of this leading industry conference and showcase our recently launched testing platform to the more than 20,000 attendees,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “AACC is an important opportunity for us to connect with global leaders, highlight new assays under development and identify additional partnership opportunities.”

A palm-sized, reusable dock with disposable test cassettes, the Accula System, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes to guide same day treatment decisions. Accula Flu A/Flu B, the first commercialized test on the platform, is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

The Accula System is well positioned to expand into additional markets and indications. The handheld platform delivers flexibility in point of care, ranging from the physician’s office and walk in clinics to emergency rooms. The proprietary assay design allows for the rapid development of tests for human, agricultural, food pathogens, or genetic disease targets.

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s AcculaSystem consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. For more information visit http://www.mesabiotech.com.

Contact Information
Joleen Schultz

Joleen@joleenschultzassociates.com

Cell:  760-271-8150

Mesa Biotech to Demonstrate New Molecular POC Testing Platform at the European Congress of Clinical Microbiology and Infectious Diseases

SAN DIEGO – April 18, 2018 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will demonstrate its novel Accula™ Flu A/Flu B test at the 28th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).  ECCMID is being held on April 21 – 24, 2018 in Madrid, Spain and the Accula System will be on exhibit in Booth 26A. The System obtained CE Mark in the European Union (EU), as well as 501(k) clearance and CLIA Waiver from the U.S. Food and Drug Administration (FDA) earlier this year.

Diagnosis of influenza is difficult because initial symptoms can be similar to other upper respiratory virus infections. The patented Accula system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Further, because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnostics are required to direct therapy for these viral infections.

The Accula System, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes to guide same day treatment decisions. The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

“We are wrapping up a devastating flu season in both Europe and the U.S., reinforcing the need for a rapid and accurate POC diagnostic that enables doctors to begin the appropriate treatment as soon as possible,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “With distributors identified in key EU markets, we are continuing to expand our distribution network for our initial Accula Flu A/Flu B test, as well as for follow-on POC diagnostics on our expandable PCR platform.”

About Mesa Biotech Inc.
Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s Accula™ System consists of a portable, palm-sized dock and a disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassays tests. Mesa Biotech’s technology development has been funded to date by a series of grants and capital investments.  For more information visit http://www.mesabiotech.com.

Mesa Biotech Receives FDA 510(k) Clearance and CLIA Waiver for Its
Accula Point of Care Flu A/Flu B Test

SAN DIEGO, CA – February 7, 2018 – Mesa Biotech Inc., a privately held, molecular diagnostic
company that has developed an affordable PCR (polymerase chain reaction) testing platform
designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that
it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA)
waiver from the U.S. Food and Drug Administration (FDA) for its Accula Flu A/Flu B test. The
company’s Flu A/Flu B test cassette will be its first available test in the U.S. market.
“The Flu A/Flu B product is the first test cassette on our PCR testing platform to receive FDA
clearance. This announcement follows our CE Mark certification and launch of our Flu A/Flu B
test last month in Europe,” said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. “This is an
outstanding validation of our testing platform and we remain focused on additional product
development and commercialization of our expandable PCR system.”

According to the World Health Organization (WHO), annual influenza epidemics are estimated
to result in about three to five million cases of severe illness, and 250,000 to 500,000 deaths.
Diagnosis of influenza is difficult because initial symptoms can be similar to other upper
respiratory virus infections. The FDA, Centers for Disease Control (CDC), and WHO all
acknowledge that existing POC immunodiagnostic tests perform poorly. Rather, molecular
testing is recommended, as influenza is a rapidly evolving virus. Further, because antiviral
medications for influenza are only effective when taken within 48 hours of symptom onset,
rapid diagnosis is required to direct therapy for these viral infections.

CLIA establishes quality standards for laboratory testing to ensure the accuracy and reliability of
patient test results. CLIA waived tests must meet stringent quality requirements to be used in
non-laboratory POC settings. The CLIA-waived Accula Flu A/Flu B test brings PCR testing to the
POC providing a qualitative result in approximately 30 minutes to guide same day treatment
decisions. The Accula Testing System offers the simplicity, convenience and procedural
familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity,
specificity and information content of laboratory-based PCR testing. The Accula Flu A/Flu B test
is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs
and allows for a more comfortable specimen collection experience for the patient.

Mesa Biotech entered a strategic alliance in early November with Sekisui Diagnostics for
exclusive product distribution rights in the U.S. and Canada. Leveraging Sekisui Diagnostics’
established channels and strong reputation among healthcare providers, Mesa Biotech will
have immediate access to distribution into North America markets. The Accula Flu A/Flu B
test will be marketed by Sekisui Diagnostics under the Silaris brand.

About Mesa Biotech Inc.

Mesa Biotech designs, develops and manufactures next generation molecular diagnostic tests,
bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-ofcare
(POC). Mesa Biotech’s Accula™ System consists of a portable, palm-sized dock and a
disposable, assay-specific test cassette. This patented system will allow healthcare
professionals to access actionable, laboratory-quality results at the POC with greater sensitivity
and specificity than current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s
technology development has been funded to date by a series of grants and capital investments.
For more information visit http://www.mesabiotech.com

Contact Information

Joleen Schultz
Joleen@joleenschultzassociates.com
Cell: 760-271-8150

Mesa Biotech Obtains CE Mark for its AcculaTM Point of Care Testing System

Company Launches Molecular Flu A/Flu B Test in the EU

SAN DIEGO, CA – January 24, 2018 – Mesa Biotech Inc., a privately held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it has obtained CE Mark in the European Union (EU) for its Accula System. The first available test in the EU market will be the company’s Flu A/Flu B Test.

Diagnosis of influenza is difficult because the initial symptoms can be similar to other upper respiratory virus infections. The FDA, CDC, and WHO all acknowledge that existing POC immunodiagnostic tests perform poorly. Molecular testing is recommended, as influenza is a rapidly evolving virus. Further, because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnostics are required to direct therapy for these viral infections.

The Accula System, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes. The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

“The introduction of the Accula System and its Flu A/Flu B test as our first PCR assay in the European market is an important validation of our platform and a critical strategic milestone for Mesa Biotech. Our proprietary assay design enables rapid development of a portfolio of cassettes to test for human, agricultural, food pathogens, or genetic disease targets,” said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. “The CE Mark indicates a product’s compliance with applicable EU regulations and enables the commercialization of our products. This, in turn, will provide significant benefits to clinicians and patients by offering reference laboratory performance at the point-of-care.”

According to the WHO, annual influenza epidemics are estimated to result in about three to five million cases of severe illness, and about 250,000 to 500,000 deaths. In industrialized countries, most deaths associated with influenza occur among people age 65 or older. Epidemics can result in significant work/school absenteeism and productivity losses. Clinics and hospitals can be overwhelmed during peak illness periods. The estimated economic burden of influenza-like illness ranges between $71-$163 billion in the U.S. alone.

About Mesa Biotech Inc.

Mesa Biotech designs, develops and manufactures next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s AcculaSystem consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s technology development has been funded to date by a series of grants and private equity investments.  For more information visit http://www.mesabiotech.com.

Contact Information
Joleen Schultz
joleen@joleenschultzassociates.com
Cell:  760-271-8150

 

  • Sekisui Diagnostics becomes exclusive distributor for Mesa Biotech products in the U.S. and Canada
  • Strategic alliance expands Sekisui Diagnostics’ portfolio and facilitates entry into the molecular point-of-care (POC) market starting with Flu A/Flu B test (pending FDA clearance) followed by additional upper respiratory infectious disease assays
  • Mesa Biotech products will have immediate access to established distribution into North America markets due to Sekisui’s market strength and strong reputation among healthcare providers

LEXINGTON, MA   December 5, 2017 — Today, Sekisui Diagnostics and Mesa Biotech Inc. announce a strategic alliance, to distribute the Mesa Biotech POC molecular system for Flu A/Flu B.   Sekisui Diagnostics will assume exclusive distribution of the Mesa Biotech POC system in the U.S. and Canada, pending FDA clearance.

The Mesa Biotech molecular dock and test cassette system provides physicians with rapid infectious disease diagnosis at the point of care with increased sensitivity and specificity over most rapid tests currently on the market by using nucleic acid PCR (polymerase chain reaction) amplification technology. The first test cassette will test for Flu A/Flu B with additional tests to be added over time.

“Sekisui Diagnostics is pleased to announce our new relationship with Mesa Biotech which will complement our existing rapid test portfolio,” said Robert Schruender, President and COO of Sekisui Diagnostics. “This system is highly compatible with our business channels and relationships with distributors. It also offers the potential to strengthen our flu portfolio in the mid-to-long term by offering physicians the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing.”

“We are extremely excited to partner with Sekisui Diagnostics for the commercialization of Mesa Biotech’s point of care PCR platform in North America,” said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. “Our PCR platform solution and pipeline coupled with Sekisui’s Diagnostics commercial and supply chain expertise as well as their unparalleled field sales relationships brings tremendous synergy opportunities for both organizations.”  

 About Sekisui Diagnostics

Sekisui Diagnostics is a global diagnostics company committed to improving patient’s lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network.  Product lines include clinical chemistry and coagulation systems, reagents, point-of-care systems and rapid tests, as well as enzymes and specialty bio-chemicals. For more information visit http://www.sekisuidiagnostics.com.

About Mesa Biotech Inc.

Mesa Biotech designs, develops and manufactures next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s System consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s technology development has been funded to date by a series of grants and private equity investments.  For more information visit http://www.mesabiotech.com.

Sekisui Diagnostics Media:

Lisa Turner, +1 (858) 777-2660
Lisa.Turner@sekisui-dx.com

Mesa Biotech  Media:

Joleen Schultz, +1 (760) 271-8150
joleen@joleenschultzassociates.com

Mesa Biotech to Present Research at Association for Molecular Pathology 2017 Annual Meeting

SAN DIEGO, CA – November 1, 2017 – Mesa Biotech, Inc., a privately-held, molecular diagnostic company that has developed an affordable PCR testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it will present original research at the annual Association for Molecular Pathology (AMP) meeting, being held November 16 – 18, 2017 at the Calvin L. Rampton Salt Palace Convention Center in Salt Lake City, Utah.

 

Presentation Title: Comparison of the AcculaÔ Influenza A/B PCR Assay and AlereÔ Influenza A/B Isotherm Amplification Assay for the Detection of Influenza in Adult and Pediatric Populations

Speaker: Dr. Steve Young, Director of Research and Clinical Trials, TriCore Reference Laboratory

Time: November 18, 9:45 am – 10:45 am
Place: Exhibit Hall
Poster Number: ID25

“Our new technology aligns nicely with this year’s AMP Conference theme ‘Where Molecular Leads Medicine to Best Patient Care,” said Dr. Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “We are excited to present our latest findings and research affirming the value of our first molecular PCR assay for use at the point of care for enhanced patient care.”

The AMP conference is a four-day event attended by clinical practitioners/physicians, research scientists, medical education professionals, laboratory professionals and students with an interest in diagnostic, prognostic, and therapeutic approaches in molecular pathology. The conference features cutting-edge lectures and discussions, corporate-sponsored workshops and plenary sessions focusing on major areas of clinical molecular diagnostics.

About Mesa Biotech Inc.

Mesa Biotech designs, develops and manufactures next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech’s AcculaSystem consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s technology development has been funded to date by a series of grants and private equity investments.  For more information visit http://www.mesabiotech.com.

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Contact Information
Joleen Schultz
Joleen@joleenschultzassociates.com
Cell:  760-271-8150

 

SAN DIEGO – May 23, 2017 – Mesa Biotech Inc., a privately held, molecular diagnostic company that has developed a molecular testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it has received an internationally recognized ISO quality certification. This designation marks the completion of a critical step for the commercialization of Mesa Biotech’s novel Accula™ System in the European Union (EU) and the United States (US).

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 13485:2003 specifies the requirements for quality that an organization needs to demonstrate to provide medical devices and related services that consistently meet customer and regulatory requirements. This certification is a critical path precursor to the commercialization of medical devices in the EU.

“Achieving ISO certification demonstrates that Mesa Biotech has successfully implemented a quality management system that conforms to the world-wide standard for medical device and in vitro diagnostic manufacturing,” said Hong Cai, co-founder and CEO of Mesa Biotech. “This is an important milestone for the company as we prepare for commercialization of our Accula System in the EU and US. It is also a testament to our commitment to quality across all functions of the business, from design and development to manufacturing and supply.”

About Mesa Biotech Inc.

Mesa Biotech is an emerging molecular diagnostic company, bringing the superior diagnostic performance of nucleic acid amplification to the point-of-care (POC). Mesa Biotech’s Accula™ System consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC in 30 minutes or less with greater sensitivity and specificity than many current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s technology development has been funded to date by a series of grants and private equity investments.

For more information visit http://www.mesabiotech.com.

 

Mesa Biotech Hires Steven Sepulveda to Head  Global Business Development and Channel Management

 SAN DIEGO, CA – May 10, 2017 – Mesa Biotech Inc., a privately held, molecular diagnostic company that has developed a molecular testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced the appointment of Steven Sepulveda as Vice President Global Business Development and Channel Management. Sepulveda will be responsible for directing and overseeing all aspects of commercial global sales, business development, strategic alliances and distributor relationship management.

“Steven is a critical strategic hire for Mesa Biotech as we prepare for securing our CE-IVD Mark in Europe, FDA approval in the U.S., and product launch in the EU and US,” said Hong Cai, co-founder and CEO of Mesa Biotech. “He has a proven track record leading global medical diagnostic companies, including Quidel, Beckman Coulter, and Sekisui Diagnostics, where he most recently served as Head of Sales and Corporate Alliances. We look forward to his leadership in developing identified markets, achieving our sales plans, and advancing our distribution partnerships.”

Sepulveda comes to Mesa Biotech with more than 26 years of experience in business development, in vitro diagnostic sales and distribution channel management. He got his start in the industry with Quidel Corporation in sales and later advanced into business development and corporate accounts. Sepulveda has held leadership positions with increasing responsibilities leading sales organizations domestically and internationally, overseeing joint ventures, and developing distribution management in health systems.  He has served as board member at the Health Industry Distribution Association’s Education Foundation and a number of industry advisory councils. Sepulveda is a graduate of the University of Puerto Rico Medical Science Campus.

About Mesa Biotech Inc.

Mesa Biotech is an emerging molecular diagnostic company, bringing the superior diagnostic performance of nucleic acid amplification to the point-of-care (POC). Mesa Biotech’s AcculaSystem consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC in 30 minutes or less with greater sensitivity and specificity than many current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s technology development has been funded to date by a series of grants and private equity investments.

For more information visit http://www.mesabiotech.com. 

Contact Information
Joleen Schultz
Joleen@joleenschultzassociates.com
Cell:  760-271-8150

 

Mesa Biotech to Preview New POC Testing Platform at the European Congress of Clinical Microbiology and Infectious Diseases

 SAN DIEGO, CA – April 18, 2017 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed a testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it will preview its novel AcculaSystem for POC molecular diagnostics at the 27th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held April 22 – 25, 2017 in Vienna, Austria.  The Accula Dock and Accula Flu A/Flu B test cassette will be previewed in Booth 79. The platform, not yet for sale, is expected to receive CE Mark approval and be available for distribution in Europe this summer.

In preparation for product launch, Mesa Biotech has been recommended for ISO 13485:2003 Certification. This designation confirms the company’s Quality Management System for medical devices responds to the rigorous standards of design, development, and production of devices intended for rapid diagnosis of infections at POC.  This certification is a precursor to a CE mark for the Accula  flu test and its commercialization in the EU.

“We are pleased to introduce our Accula dock and disposable cassette at the EECMID Congress where the world’s leading experts gather to discuss the latest developments in infectious diseases, infection control and clinical microbiology. It is a great opportunity to showcase our innovative POC system as well as continue to develop commercialization relationships,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “This past year we have focused on getting our manufacturing facility up and running, securing ISO certification, and preparing for commercial launch. These are important milestones in Mesa Biotech’s strategy to obtain CE marking for our first product and will provide an important level of assurance to clinicians and patients who benefit from this medical advancement.”

About Mesa Biotech Inc.

Mesa Biotech is an emerging molecular diagnostic company, bringing the superior diagnostic performance of nucleic acid amplification to the point-of-care (POC). Mesa Biotech’s AcculaSystem consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC in 30 minutes or less with greater sensitivity and specificity than many current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s technology development has been funded to date by a series of grants and private equity investments.

For more information visit http://www.mesabiotech.com.

 

Contact Information
Joleen Schultz
Joleen@joleenschultzassociates.com
Cell:  760-271-8150