What’s up with OraSure’s self-test?
Bethlehem company expanding as it seeks FDA authorization
When reflecting on his company’s efforts over the past year to develop a COVID-19 rapid selftest and the road ahead, Stephen Tang thinks about it like a relay race.
“You move from R&D to manufacturing to sales and marketing, and everybody has their role in the race,” said Tang, president and CEO of OraSure Technologies Inc. “Those that aren’t running right now are getting ready to run — and run quickly.”
The Bethlehem company is finishing up one leg of that lengthy race, disclosing Monday it has finalized all product development and completed clinical studies for its rapid antigen self-test, in which a person swabs their nostril, swirls it in a vial and then gets the result quickly. By the end of this month, OraSure plans to seek emergency use authorization from the U.S. Food and Drug Administration for the professional and prescription self-tests, the former for use at drive-thru sites, doctors’ offices and public health sites and the latter for at-home use by
consumers with a prescription.
While it’s hard to forecast the duration of the FDA’s review, Tang said that process could take in the ballpark of six to eight weeks. To date, the FDA has granted emergency use authorization to 335 tests and sample collection devices, but that includes only four at-home tests: two antigen prescription tests, one molecular prescription test and one over-the-counter antigen test. For that reason and others, OraSure believes significant opportunity remains for at-home testing in the United States and internationally as the bumpy vaccination rollout continues.
For one, President Joe Biden’s American Rescue Plan proposes spending $50 billion in a massive expansion of COVID-19 testing. In addition, a December report from The Rockefeller Foundation called on the U.S. government to scale up to 300 million tests per month for students, teachers and staff to reopen — and keep open — the country’s public schools.
“The best minds have said, essentially, that vaccines and testing need to work together to get us back to ‘normal,’ ” Tang said.
As OraSure readies its submissions to the FDA, Tang said the company will be “manufacturing at risk,” allowing it to build inventory of the tests in anticipation of obtaining emergency use authorization and getting the product to market.
The company’s Lehigh Valley footprint will play a major role in those efforts. In August, OraSure joined state officials in Harrisburg to announce a $7.5 million expansion in the Lehigh Valley that would help the firm keep pace with anticipated demand.
Tang said construction is ongoing at the company’s location in South Side Bethlehem to build the manufacturing lines. The expansion is expected to create 177 full-time jobs and retain 233 positions across three OraSure locations in Bethlehem and one in Bethlehem Township.
In total, OraSure is expanding its manufacturing capacity to 70 million tests per year by the third quarter of this year, annual output that includes 17 million units for its tests for HIV, Ebola and the hepatitis C virus.
The company plans to boost that capacity to 120 million tests per year by the second quarter of 2022, which takes into account an additional 50 million rapid antigen self-tests to support expected sales outside the United States.
OraSure, according to its justfiled annual report, plans to manufacture its COVID-19 rapid antigen self-test at its Bethlehem facilities and, to supply certain international markets, at a thirdparty site in Thailand.
Tang said OraSure sees opportunity for its test in the U.S. market well into 2022, especially as the vaccine rollout encounters logistical hurdles, concerns pop up over virus variants and as international travel eventually returns. Looking globally, he noted the international need for testing since many countries will not immediately have vaccines widely available.
“We do see the runway in the U.S. at least through 2022 and then the rest of the world for several years beyond that,” Tang said.
OraSure also still plans to pursue authorization for an overthe-counter test, but wants to see how the prescription self-test product performs in the market. OraSure has not announced a specific price for its self-test, but Tang said the company has pointed to a reimbursement code for a similar product, and that is in the range of $41.
In addition to the rapid test, OraSure is working with the FDA to secure emergency use authorization for its lab-based antibody ELISA test that would detect prior infection and aid health officials in community surveillance efforts.
In December, OraSure disclosed that the FDA had requested additional information as part of its review for the antibody test.
Further, strong sales of OraSure’s molecular sample collection kits for COVID-19 testing helped boost fourth-quarter net revenues to about $63 million, a result that beat analyst expectations and was up 27% from the year-earlier period.
The company on Monday reported fourth-quarter net income of $1.9 million, or 3 cents a share, that fell short of Wall Street’s expectations.
OraSure’s stock closed at $11.08 on Tuesday, up 2 cents from Monday.
With the rapid antigen selftest, it’s been a long road for OraSure to get to this point.
It was last April when OraSure announced it had won a $710,000 federal contract to develop a COVID-19 in-home test. The company, at that time, anticipated a development cycle of about four to six months, hoping to bring the test to market by late summer or early fall.
Like everyone else, Tang said OraSure learned from the science as it went and is now in a good place as it seeks emergency use authorization. He called the company’s progress on the test “remarkable,” especially since OraSure, with 570 employees companywide, is substantially smaller than many of its competitors in the multibillion-dollar diagnostic industry.
While Tang said he’s proud of where OraSure is positioned, there’s much more work to be done.
“It’s not the end,” he said. “It’s the end of the beginning, I think, for us. Once we get into market, we’re going to do what we do best, which is the commercial development and the manufacturing and the sales and marketing.”
The next leg of the relay.