Bethlehem firm’s spit test for COVID-19 is coming closer

In the shadow of the hulking Bethlehem Steel foundry, whose long-idled smokestacks stand like tombstones for the defunct industrial giant, a Pennsylvania technology company is racing to “democratize” testing for COVID-19.

By September, Bethlehem’s OraSure Technologies Inc. hopes to have a rapid, oral-fluid self-test on the market, one as quick and simple to use as those that can detect pregnancies. Available over the counter and able to produce results within 20 minutes, it likely would sell for less than $50, though recent federal law mandates that all public and private insurance plans must cover the cost of COVID-19 testing.

“An in-home test like this will reduce the pressure on overburdened health-care systems and reference laboratories,” said Stephen Tang, OraSure’s CEO and president. “It will be easier and less painful to administer than the nasopharyngeal or oropharyngeal [behind the nose and throat] tests while at the same time protecting health-care providers.”

The 33-year-old Lehigh Valley company, which created similar tests for HIV and Ebola, began work on the new device in January. Granted $710,000 for the task by the federal BARDA (Biomedical Advanced Research and Development Authority), OraSure also raised $95 million through a June stock offering, in part to ramp up for what it hopes will be worldwide demand for the personal test.

“We’re extremely well-positioned because of the work we’ve done on these other tests, so we’ve been able to pivot very quickly into this opportunity,” Tang said.

The device faces a lot of competition and design challenges even if it achieves Tang’s vision of “a lab on a swab,” a one-step, do-it-yourself means of searching oral fluid for the COVID-19 antigens that indicate a live infection.

According to the Mayo Clinic, antigen-based tests, which look for specific proteins in the deadly virus, are often less dependable than those designed to detect antibodies, and a second test is sometimes required for confirmation. Figures aren’t yet available on the accuracy of OraSure’s, but according to the FDA, the company’s HIV test is 92% accurate in detecting positives, 99.8% for negatives.

“Ultimately,” Tang said, “we would hope that an antigen test would be highly specific and highly sensitive so that you don’t need a confirmation test, but that does remain a possibility.”

At this point in the pandemic, most of the existing COVID-19 testing has been molecular-based, in which fluid collected on a nasal swab is sent to a lab where its genetic material is processed and analyzed through the PCR (polymerase chain reaction) technique.

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Because testing remains the only reliable way to separate the infected from the noninfected, a quick and reliable system that could be conducted without medical personnel or expensive equipment could be a game changer.

While totals in the United States have risen gradually during the outbreak, the number of daily tests administered has not yet reached the five million that experts have said would be necessary by the end of June. And one recent Harvard study estimated that the goal should be 20 million a day by mid-summer.

“We can’t build labs fast enough, to get to that number,” said Tang, who lives in Bala Cynwyd and is the former CEO of the University City Science Center in West Philadelphia. “Our test essentially would democratize testing, putting the power back into the individuals’ hands to test themselves. It would allow for an element of self-control that we don’t have today.”

In the race to meet such demand, the FDA has granted emergency authorizations to more than 100 COVID-19 testing devices; a few, such as OraSure’s, can be performed by individuals in their homes. But most require the material to be then tested in a lab.

In May, Rutgers’ Clinical Genomics Laboratory won FDA approval for an in-home, oral-fluid test. But it requires that the collected sample be sent to a lab for analysis. And E25Bio of Cambridge, Mass., has developed a test for individuals that generates results in 15 minutes. But instead of saliva, it analyzes nasal samples collected by invasive swabs. Other companies have systems that rely on blood examination.

OraSure is aiming to have a prototype within weeks. It hopes at some point to be offering millions of units for sale. (It also hopes to develop a COVID-19 antibody test, which determines whether a person has had the virus in the past, by the end of July.) To get the test on the market, it will seek in the fall what is called an emergency-use authorization from the FDA, which is in effect only during a public health emergency like COVID-19.

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“At that point, we’ll start to build inventory on our own,” Tang said. “We hope to launch the product in September with millions of units for sale then.”

Whenever it’s developed and authorized by the FDA, though, it will look and work a lot like the company’s existing test for HIV, a product that’s been used by millions around the world since its development in 2004. The only new elements will be those required to specifically detect COVID-19.

“You have to have the components right,” Tang said. “The better you are at understanding them and putting them together, the better the end product will be.”

That understanding has been aided by the company’s experience with HIV and the Ebola virus. When Ebola surfaced in 2015, OraSure had a test ready in nine months. This year, soon after word of COVID-19 arose in China, company executives and scientists started shifting their focus, using the existing products as blueprints.

“We know how the process works,” Tang said.

OraSure’s test will utilize a long swabbing device that resembles a miniature canoe paddle. A porous pad at its tip will be swiped between the cheek and gum, then placed in a tube with a preset amount of developing solution. There the sample will react with reagents. If a COVID-19 antigen is present, a colored line will form in the result window.

“There are particular proteins that are linked specifically to that virus,” Tang said. “Looking for them is just a biological process. It works like a lock and key. There’s a component to the antigen, and we develop antibodies specifically to hold on to the antigen.”

OraSure stock, which was trading at about $11 a share late last week, has sold at $5.23 to $18.27 in the last year. The company reported pretax income of $22 million in 2019 on sales revenue of $154.6 million. The pandemic has slowed demand for some products, but the prospect of a COVID-19 test has kept its nearly 400 employees busy. And, should a test reach the marketplace, the Bethlehem plant, where manufacturing and research and development are headquartered, will be the center of the action.

“Everything related to our COVID-19 products would all be made in Bethlehem,” Tang said.

Pricing decisions await, but as a point of reference, Tang noted that the company’s HIV in-home test typically sells for “about $40,” less in poor and developing countries.

“OraSure has a history of rising to the occasion in challenging health circumstances,” Tang said. “We’re doing everything we can to bring our expertise with infectious disease diagnostics in sample collection to the battle against COVID-19.”