OraSure Hopes to Have 2 Covid-19 Tests Approved by Year-End

Products give instant results and don't require a lab or equipment

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Sep 08, 2020
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A prominent Harvard epidemiologist and expert in disease testing thinks a cheap, daily, do-it-yourself test can be as effective as a vaccine at cutting coronavirus transmission, according to an article in the Harvard Gazette. Right now, such a test is the best bet for helping society return to some semblance of normal, said Michal Mina, assistant professor of epidemiology at Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital.

One company seeking to provide a pair of tests that give instant results and can be done without equipment or a lab is OraSure Technologies Inc. (OSUR, Financial). The Pennsylvania-based company has the tests in clinical trials and said it is going to ask the Food and Drug Administration to approve both by the end of the year. One test would show if someone is infected with Covid-19. The other would determine if someone has already been infected and has antibodies that might protect against future infections.

"Our goal is to test anybody, anywhere, at any time," Dr. Stephen Tang, the CEO of OraSure, said. The likelihood of OraSure's success is enhanced by its track record. The 30-year-old company has developed products that rapidly check for HIV, hepatitis C and Ebola.

"Unlike most companies who are just getting started in this area of rapid tests, we have products that have been performing for years," he told the Morning Call.

OraSure traded as high as $19.75 as recently as a month ago, but has since backed off to just below $10.50 after the company reported disappointing results for the second quarter. Sales for the three-month period ending June 30 were down 25% from a year earlier, and at $29.3 million fell short of analyst expectations by $3.5 million. However, during a recent earnings call, Tang predicted a strong rebound in the last half of the year based in great part on its Covid tests.

Elsewhere on the testing front, Abbott Laboratories (ABT, Financial) recently made a breakthrough when the company's rapid test for detection of Covid-19 was approved by the FDA under Emergency Use Authorization. Abbott's test, which will sell for $5, is about the size of a credit card and provides results in 15 minutes without the use of any equipment.

Also vying for a share of the market is 3M Co. (MMM, Financial), which is collaborating with scientists at the Massachusetts Institute of Technology on a rapid test. Two smaller companies working on speedy tests are privately held firms, E25Bio and Sherlock Biosciences, both based in Cambridge, Massachusetts.

Also in the mix is biopharma company Sorrento Therapeutics Inc. (SRNE, Financial). The San Diego-based company recently entered a licensing agreement with Columbia University to bring to market a Covid-19 test that uses saliva and gives results in 30 minutes. Investors are looking for any sliver of good news from Sorrento, whose shares trade at just more than $6 and have been essentially flat for nine years.

Disclosure: The author holds no position in any of the stocks mentioned in this article.

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