Bethlehem-based OraSure Technologies Inc. said Wednesday it anticipates a fourth-quarter 2020 launch of its in-home test kits for current and past infections of COVID-19.
OraSure says oral fluid collection devices from its DNA Genotek subsidiary are already in use for sample collection in the fight against the coronavirus illness, under U.S. Food and Drug Administration Emergency Use Authorizations. Its devices are helping in the push to return to work and to school across the country, according to a news release from the company Wednesday.
The in-home test kits are being developed with $710,310 in funding announced in April and $629,217 received in June, both from the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority.
One is called the OraQuick Coronavirus Rapid Antigen Self-Test, “designed to produce a result for active COVID-19 infection within minutes, with no instrumentation needed to interpret the results and no need to transport samples to a lab for processing, enabling the detection of COVID-19 infection anytime, anywhere.”
OraSure says this “test is built on its proven OraQuick lateral flow platform, which is the foundation for OraSure’s current ‘in-home’ and professional rapid diagnostics for HIV,” the virus that causes AIDS, in addition to professionally administered Hepatitis C tests and Ebola test cleared for 510(k) FDA pre-market testing.
“Although originally intended for use with oral fluid, this test has been modified to employ an easily and comfortably self-collected lower nostril sample in order to achieve the best possible accuracy,” OraSure says in its release.
OraSure says it expects the antigen test to be a game-changer in helping to diagnose infections. “A recent Rockefeller Foundation report on testing specifically calls for rapid, convenient tests to help get to the 30 million tests per week many believe are needed by November to reduce the spread of COVID-19,” the release states.
According to mayoclinic.org, “When more COVID-19 diagnostic tests are available, people who test positive and have symptoms can get care earlier. Contacts can be traced and self-isolation or quarantine started sooner to help stop the spread of the virus.”
OraSure says its SARS-CoV-2 Antibody test employs “Enzyme-Linked Immunosorbent Assay (ELISA) using oral fluid to detect human anti-SARS-CoV-2 antibodies that would enable specimen collection in any location, promoting social distancing.”
“The test would utilize the Company’s existing OraSure oral fluid specimen collection device,” the release states. “To date, there are no commercially available anti-SARS-CoV-2 antibody tests using oral fluid samples with automated assays.”
Accurate testing for COVID-19 antibodies, according to the nonprofit Mayo Clinic, “will indicate how many people had COVID-19 and recovered, including those who didn’t have symptoms. This aids in determining who might have immunity. It can also help in contact tracing to assess who else is at risk of infection and how far the disease spread. All of this data will help improve strategies to curb the COVID-19 pandemic.”
Both the antigen and antibody tests are currently in human clinical testing. OraSure says it expects to meet or exceed applicable FDA performance requirements for both, with Emergency Use Authorization filing and subsequent commercial launch in the fourth quarter, pending regulatory approvals.
OraSure has not disclosed pricing for either test and says to expect a phased approach in the availability of the tests under the Emergency Use Authorization, or EUA.
“We will follow FDA requirements for EUA which typically start with authorization for prescription use followed by over-the-counter authorization,” spokeswoman Jeanne Mell told lehighvalleylive.com in an email. “We expect to take a phased approach. Our initial launch will be into the professional market for testing symptomatic individuals or individuals that have come in contact with people infected with COVID-19 or suspected of COVID-19 infection. The second phase will be a prescription use self-test with the same intended use population as the professional product. The third phase will be OTC where we will be looking to obtain a claim for asymptomatic individuals. The goal is for EUA of the first two phases in Q4.”
OraSure announced its COVID-19 test updates as part of its financial results for the three and six months running through June.
“In the second quarter, our work to leverage our scientific and technological expertise against the COVID-19 pandemic has already generated meaningful revenue,” President and CEO Stephen Tang says in the release. “Our sample collection devices are being used for the collection, both in at-home and professional settings, and transport of samples for COVID-19 molecular testing.”
“We are confident, given our ongoing initiative to scale up our production capacity, that OraSure will be able to deliver substantially increased volumes of collection and testing products, while ensuring that they meet the highest quality standards as we contribute to the fight against this global crisis,” he continued. “At the same time, we have continued to serve our existing customers across our business lines and to identify opportunities for business development that will contribute to longer-term sustainable growth.”
OraSure got its start in 1987 as Solar Care Technologies at the Ben Franklin TechVentures business incubator at Lehigh University, focusing on developing sunscreen towelettes. Its headquarters are at 220 E. First St. on Southside Bethlehem. Its cash and investments totaled $265.8 million as of June 30.
The company is one of several in the Lehigh Valley innovating ways to combat the spread of COVID-19.
Globally, there have been 18,354,342 confirmed cases of COVID-19, including 696,147 deaths reported to the World Health Organization. The United States has seen 4,678,610 confirmed cases of COVID-19 with 154,952 deaths, the WHO says.
Pennsylvania’s coronavirus case count rose Wednesday to 115,714 with a death toll of 7,244. New Jersey has now reported 15,842 confirmed and probable deaths related to COVID-19, with 183,327 total cases. Both state’s outbreaks began in early March.
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Kurt Bresswein may be reached at kbresswein@lehighvalleylive.com.