OSUR: Contract w/ BARDA to Develop Home COVID19 Test
Apr 7, 2020 14:51:56 GMT
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Post by icemandios on Apr 7, 2020 14:51:56 GMT
Item 7.01 – Regulation FD Disclosure.
On April 6, 2020, OraSure Technologies, Inc. (the “Company”) issued a press release in which it announced that it has entered into a contract with the Biomedical Advanced Research and Development Authority to develop a pan-SARS-coronavirus antigen rapid in-home self-test for use with oral fluid samples. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
In addition to the rapid coronavirus antigen self-test disclosed in the press release, we are evaluating the development of antibody tests, including a lab-based oral fluid microplate coronavirus antibody enzyme-linked immunosorbent assay (ELISA).
On April 6, 2020, OraSure Technologies, Inc. (the “Company”) issued a press release in which it announced that it has entered into a contract with the Biomedical Advanced Research and Development Authority to develop a pan-SARS-coronavirus antigen rapid in-home self-test for use with oral fluid samples. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
In addition to the rapid coronavirus antigen self-test disclosed in the press release, we are evaluating the development of antibody tests, including a lab-based oral fluid microplate coronavirus antibody enzyme-linked immunosorbent assay (ELISA).
The information in this Item and attached Exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing. The fact that the information and Exhibit are being furnished should not be deemed an admission as to the materiality of any information contained therein. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Current Report or attached Exhibit.
OraSure Technologies Receives BARDA Contract for Rapid Oral Fluid Pan-SARS-Coronavirus In-home Self-test
BETHLEHEM, PA, April 6, 2020 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices and microbiome laboratory and analytical services, today announced it has been awarded a $710,310 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), to develop a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples. This support from BARDA will enable OraSure to file for FDA Emergency Use Authorization (EUA) allowing for an in-home self-test to debut into the U.S. market.
Built on OraSure’s OraQuick® platform, the rapid test would allow for in-home self-testing by lay users as well as by medical professionals. OraSure’s portable rapid test platform uses an oral fluid sample and provides results in 20 minutes. No instrumentation or trained personnel would be needed to administer the test or to read the results. OraSure has a well-documented history of success with in-home infectious disease testing; the Company’s oral fluid self-test for HIV has been used to diagnose millions of people around the world and connect them to life-saving care.
Once developed and the necessary approvals are obtained, an in-home self-test for SARS-coronavirus would help alleviate the pressure on over-burdened healthcare systems. Healthcare providers, retailers, and online vendors could ship tests directly to an individual’s home, eliminating unnecessary trips to hospitals, doctors’ offices, and testing facilities. This would help maintain social distancing and curb the spread of coronavirus through symptomatic and asymptomatic transmission. Rapid in-home testing could also ease the burden on lab-based testing.
Most current coronavirus tests require a nasopharyngeal or oropharyngeal sample, which can be painful to collect and difficult to attain through self-sampling. An effective test based on an oral sample that can be used in home would enable an easier and pain-free sample collection, as well as much wider access to testing.
A rapid antigen test would also aid in screening initiatives to identify individuals with acute COVID-19 infection with or without symptoms, allowing immediate follow-up access to the patient for further testing and/or quarantine and treatment if necessary.
OraSure envisions a rapid development cycle of approximately 4-6 months prior to seeking Emergency Use Authorization (EUA).
“Lives and global economies are at stake. It’s crucial that we understand just how many people are infected with SARS-coronavirus,” said OraSure President and Chief Executive Officer Stephen S. Tang, Ph.D. “In-home self-testing will dramatically increase the capacity for SARS-coronavirus testing and give our healthcare systems and labs some much-needed breathing room. We believe that the development of an easy-to-use device that delivers accurate results to individuals in their homes can play a significant role in impacting infection rates. We are proud to bring our expertise with quality, rapid, oral fluid self-tests to the battle against the COVID-19 pandemic.”
“We need to put tests into people’s hands to know their infection status and protect their loved ones. At BARDA, we are continually looking for transformative technologies to combat public health threats, and rapid at-home coronavirus testing would be a game-changer,” said BARDA Director Rick Bright, Ph.D. “We know that people can spread COVID-19 without showing any symptoms, and with rapid at-home testing people could take immediate action to prevent the spread of the virus.”
The pan-SARS-coronavirus antigen rapid in-home self-test project has been funded in whole or in part with Federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00061.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries (DNA Genotek, CoreBiome, Diversigen and Novosanis), OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.
BETHLEHEM, PA, April 6, 2020 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices and microbiome laboratory and analytical services, today announced it has been awarded a $710,310 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), to develop a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples. This support from BARDA will enable OraSure to file for FDA Emergency Use Authorization (EUA) allowing for an in-home self-test to debut into the U.S. market.
Built on OraSure’s OraQuick® platform, the rapid test would allow for in-home self-testing by lay users as well as by medical professionals. OraSure’s portable rapid test platform uses an oral fluid sample and provides results in 20 minutes. No instrumentation or trained personnel would be needed to administer the test or to read the results. OraSure has a well-documented history of success with in-home infectious disease testing; the Company’s oral fluid self-test for HIV has been used to diagnose millions of people around the world and connect them to life-saving care.
Once developed and the necessary approvals are obtained, an in-home self-test for SARS-coronavirus would help alleviate the pressure on over-burdened healthcare systems. Healthcare providers, retailers, and online vendors could ship tests directly to an individual’s home, eliminating unnecessary trips to hospitals, doctors’ offices, and testing facilities. This would help maintain social distancing and curb the spread of coronavirus through symptomatic and asymptomatic transmission. Rapid in-home testing could also ease the burden on lab-based testing.
Most current coronavirus tests require a nasopharyngeal or oropharyngeal sample, which can be painful to collect and difficult to attain through self-sampling. An effective test based on an oral sample that can be used in home would enable an easier and pain-free sample collection, as well as much wider access to testing.
A rapid antigen test would also aid in screening initiatives to identify individuals with acute COVID-19 infection with or without symptoms, allowing immediate follow-up access to the patient for further testing and/or quarantine and treatment if necessary.
OraSure envisions a rapid development cycle of approximately 4-6 months prior to seeking Emergency Use Authorization (EUA).
“Lives and global economies are at stake. It’s crucial that we understand just how many people are infected with SARS-coronavirus,” said OraSure President and Chief Executive Officer Stephen S. Tang, Ph.D. “In-home self-testing will dramatically increase the capacity for SARS-coronavirus testing and give our healthcare systems and labs some much-needed breathing room. We believe that the development of an easy-to-use device that delivers accurate results to individuals in their homes can play a significant role in impacting infection rates. We are proud to bring our expertise with quality, rapid, oral fluid self-tests to the battle against the COVID-19 pandemic.”
“We need to put tests into people’s hands to know their infection status and protect their loved ones. At BARDA, we are continually looking for transformative technologies to combat public health threats, and rapid at-home coronavirus testing would be a game-changer,” said BARDA Director Rick Bright, Ph.D. “We know that people can spread COVID-19 without showing any symptoms, and with rapid at-home testing people could take immediate action to prevent the spread of the virus.”
The pan-SARS-coronavirus antigen rapid in-home self-test project has been funded in whole or in part with Federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00061.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries (DNA Genotek, CoreBiome, Diversigen and Novosanis), OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.