Mesa Biotech has been awarded a contract up to $13 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (HHS), for development of its rapid molecular diagnostic test for detection of SARS-CoV-2 & Flu A/Flu B in a single sample. The Accula? SARS-CoV-2 & Flu A/Flu B Combination Test will provide Rapid PCR results in 30 minutes at the point of care (POC).

The combined diagnostic will be developed on the company's commercially available platform for Accula Flu A/Flu B and RSV, which are both 510(k) cleared and Clinical Laboratory Improvement Amendments (CLIA)-waived, and SARS-CoV-2, which received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

"We initially recognized the need for portable testing over a decade ago, while working at Los Alamos National Lab. The Accula testing platform was developed specifically for use outside of a lab setting to enable rapid and agile responses to global pandemics like COVID-19, as well as every day use for common infectious diseases," said Bruce Cary, Ph.D., Co-founder and Chief Scientific Officer, Mesa Biotech, Inc. "Our SARS-CoV-2 & Flu A/Flu B Combination Test leverages reverse transcription-polymerase chain reaction (RT-PCR) technology to provide 'true PCR' results in about 30 minutes using a handheld device, thus enabling health care providers to rapidly distinguish between influenza and SARS-CoV-2 with a single sample."

Combination tests work by testing a single sample from a patient for multiple respiratory diseases. As we enter the traditional influenza season, the dual test allows for simultaneous testing for influenza and COVID-19 on patients presenting with respiratory symptoms. Information about both viruses will help public health officials and healthcare providers better manage the treatment and control the spread of influenza and COVID-19 in the community, according to the Centers for Disease Control and Prevention (CDC). Additionally, combination tests alleviate the need for multiple samplings, streamline testing, require fewer supplies and reduce pressure on already strained reagent supply chains.

"The 2020-21 influenza season will pose new challenges to the public health response to the coronavirus pandemic," said Hong Cai, Ph.D., Co-founder and Chief Technology Officer, Mesa Biotech, Inc. "With two viruses that cause respiratory symptoms circulating, physicians and public health officials will need to know whether patients have COVID-19 or influenza to make informed decisions about care and take appropriate actions to minimize the spread of the pathogens."

"We value the continued confidence and support of HHS in helping evolve our Accula platform to meet the testing needs of the American people," said Ingo Chakravarty, President and CEO, Mesa Biotech, Inc. "The current pandemic has created an immense need for Rapid PCR. Our SARS-CoV-2 & Flu A/Flu B Combination Test is the next innovation in our portfolio, providing healthcare providers with the needed tools to effectively counter the pandemic."

The Accula SARS-CoV-2 & Flu A/Flu B Combination Test will be a visually read test, using reverse transcription-polymerase chain reaction (RT-PCR) technology to detect SARS-CoV-2 or Flu A/Flu B via throat, nasal or nasopharyngeal swab samples. The ergonomically designed, simple to use Accula test, fits in the palm of your hand and provides laboratory-quality results in approximately 30 minutes, helping ease the impact of seasonal influenza testing on an already stressed infrastructure. Its compact design is ideal for use at the point of need, including temporary screening facilities, back-to-work processing, hospitals, clinics and long-term nursing facilities.

BARDA is providing federal funding under contract number 75A50121P00008.