U.S. grant speeds this Pa. coronavirus test to market this year

It would help get Americans back to work if we could each sit at home, run a special swab around our teeth, dip it in fluid, and have a marker pop up on the handle 20 minutes later to show whether we have a coronavirus infection. Or that we don’t.

The U.S. government is paying Bethlehem-based OraSure Technologies to speed such a test for federal emergency approval as soon as August. If it’s cleared and proves accurate, chief executive Stephen Tang says, his company hopes to be making millions of home test kits by December.

Other coronavirus tests need nurses and laboratories, and take days or hours for results. This quick home-based test, the government hopes, could make it much simpler for workers, employers and public-health officials to track the virus and avoid the shutdowns that have put millions on the jobless rolls.

In sum, he hopes his firm will design and sell the first and dominant home-based, oral, and instant-results test for coronavirus. If he succeeds, the product could be a big step toward getting Americans out of their homes and back to work.

"Rapid, at-home coronavirus testing would be a game-changer,” Rick Bright, director of the federal Biomedical Advanced Research and Development Authority (BARDA) said in an April 6 statement.

The agency granted OraSure $710,000 to help prepare its application for FDA Emergency Use Authorization to put the kits on the market. BARDA is charged with protecting the nation from chemical, biological, and nuclear threats, along with infectious diseases such as COVID-19.

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An in-home test from OraSure would ease the burden on health-care facilities, which are struggling with collecting today’s coronavirus blood and mucus tests and transporting them to labs, Andrew Cooper, an analyst of health-care and diagnostics firms, wrote to clients at investment bank Raymond James & Associates this week.

Quick home tests would reduce uncertainty, allow some to return to work and others who didn’t know they had the virus to self-isolate, and, in short, make it easier to stop spreading the disease without forcing so many to stay home just in case.

An oral test would protect doctors and nurses and lessen the need for scarce protective gear, Cooper added. Plus, such a test would be "faster, easier, and less uncomfortable for the patient” than professionally administered, lab-evaluated blood and nasal-fluids tests, he said.

He projected that demand would be many times the 40 million yearly flu tests that U.S. doctors order.

Vaccines to block coronavirus are months or years away. Testing is simpler to design, and provides a tool for communities to slow its spread without stalling everyday life.

Unlike a vaccine that stays in the body and must be tested on animals and people for toxicity and immune-system response, tests involve the quick withdrawal of blood, saliva, mouth or nose fluids, all of which are then safely checked outside the body.

» READ MORE: New coronavirus tests could be powerful tools to manage the pandemic — if they work

OraSure’s saliva and gums test is designed to quickly find coronavirus antigens, which show that a person is infected and risks infecting others, whether or not the person has symptoms. It reveals whether people need to be isolated or can go to work and be around others without fear of spreading the disease.

Many companies are developing new coronavirus tests that can be useful in identifying and treating the disease but less helpful for fighting its spread.

Tests that draw blood from the body, such as the new lab-based coronavirus tests developed by Abbott Laboratories, typically detect antibodies, which show whether a person has been exposed, but not if they are contagious.

Home-test competitors include E25Bio, of Cambridge, Mass., which has raised $2 million from Khosla Ventures to develop a kit that people could use to test their nose mucus for coronavirus.

U.K.-based BioSure , which sells HIV home-tests available in its home turf, says it, too, is developing a home test for coronavirus. Its product would test blood.

Rutgers last week gained the FDA’s emergency authorization to begin distributing a system to test for coronavirus, in saliva extracted by medical professionals, in a partnership with Thermo Fisher Scientific. This method relies on lab testing.

The 500-employee OraSure already is one of two U.S. firms that makes kits for HIV testing. Its kit retails in the U.S. for about $40, and is sold at much lower prices in countries where they are subsidized by the Gates Foundation and other public-health donors. The rival test, Home Access HIV-1 Test System, is blood-based, while OraSure’s test uses saliva.

Last year OraSure won approval for a similar test to detect Ebola virus antigens. “We should all be thankful,” Tang said, for public-health measures that have kept Ebola from becoming a worldwide killer. The experience gained by OraSure’s Ebola approval also helped speed its BARDA application toward the FDA, Tang added.

So did support from U.S. Rep. Susan Wild (D., Lehigh),and U.S. Sens. Pat Toomey (R., Pa.) and Bob Casey (D., Pa.). “From when we submitted the application, it took under a week,” Tang said.

He got to know the senators and other government contacts during the decade he ran the University City Science Center in West Philadelphia, a consortium of Penn, Drexel and other neighborhood institutions that jointly controls a string of office blocks along Chestnut and Market Streets and has been developing new locations as medical offices and biotech labs.

OraSure sales and profits have slumped since Tang took over in 2017, and its share price had declined from above $20 at its 2017 peak to a low of $6.03 on Feb 1. In a conference call with investors that month, Tang blamed a drop in payments by 23andMe, which uses OraSure kits in its genetic sampling, as well as federal prosecutions of independent labs that used the gene kits in pitching their own questionable products and services for people with genetic issues.

But OraSure shares (OSUR) have almost doubled, to about $12 a share in recent days, after the BARDA announcement boosted hopes that the company’s coronavirus tests would prove a commercial success, analyst Cooper noted.

OraSure has not listed likely prices for the tests. Tang said he’s been in talks with private companies and government agencies that may have an interest in buying or subsidizing the kits, He added that he sees employers who want staff to safely return to work as bulk buyers.

Oral testing “has not been an easy pathway,” Tang said. “We were pioneers and innovators in that field,” which requires high sensitivity in the ridged swabs used to collect mouth fluids.

While its Bethlehem factory makes tests for the U.S. market, OraSure has another plant in Thailand for foreign markets. Together they won’t be big enough to make all the screening tests needed if demand rises fast, Tang said.

Should his test make it market, he said, he would line up contract manufacturers to help produce it.