Tag: HIV

 

When Stephen Tang took over as president and CEO of OraSure Technologies in 2018 he knew he would be leading a company on the frontlines of the fight against deadly diseases around the globe.

He had served on the board of directors of the Bethlehem company since 2011 and watched OraSure bring to market the first FDA-approved in-home HIV test and, after that, a similar test for Hepatitis C and the Ebola virus. He knew the viral diagnostic tests his company develops and manufactures have saved countless lives around the globe.

But now, with the global COVID-19 pandemic, Tang and his team at OraSure are facing their biggest challenge yet, creating a test that will accurately and quickly determine if a person has been exposed to the COVID-19 virus.

“This has been one of the most fulfilling moments of our careers,” said Tang in an interview with Lehigh Valley Business. “Seeing people pulling together – even people working from home on their dining room table like I am – there’s an enthusiasm to do something that will measurably change the world for the better.”

During a recent press conference, Pennsylvania Health Secretary Dr. Rachel Levine, called the rapid antigen test that OraSure hopes to have FDA approved and to market by year’s end a “game changer.” It would be the first antigen test on the market that wouldn’t need lab equipment or trained professionals to get result and could be easily used at home, the office or in schools.

“One of the keys to stopping the spread of COVID-19 is expanding access to testing,” she said.

Such a test could have a dramatic impact on stopping the spread of the disease, saving lives and reopening the economy, Levine said.

“We are all so grateful to be working on this,” Tang said. “We see what’s going on with health care and unemployment.”

Tang noted, the virus is posing a challenge to OraSure’s overall business.

With non-essential care put on hold and care facilities shut down or converted to COVID-19-related care, sales of other tests, such as its OraQuick HIV test, were down more than 25%. Overall, HIV testing was down 50% to 70% at the height of the pandemic, so as a diagnostic test provider they still did fairly well compared to others in the industry.

“There was a migration of products to in-home testing from doctor’s offices,” he said.

Valuable tool

In fact, he said the “in-home” part of the test platform is what has made the whole testing system so valuable to global health. With HIV, for example, there was often stigma about going to a clinic and getting tested for the virus, keeping people from getting tested. That meant people with the HIV virus weren’t getting treated for the deadly disease and were potentially spreading it to others without knowing.

The problem was particularly widespread in Africa where the virus, which is often unfortunately linked to homosexuality, kept many fearful of getting tested, Tang said.

“Homosexuality is criminalized in some African countries,” he noted. Those seeking testing could face imprisonment or even being put to death.

The lack of health care infrastructure in Africa also hobbled testing for HIV, HPC and Ebola.

When OraSure was able to get emergency use approval for its rapid Ebola tests, health care workers could go door-to-door in neighborhoods facing Ebola epidemics, test people and get those exposed to the virus quickly treated and isolated to prevent the spread.

“Translate that into COVID-19. The result of having a test available at home is that you will self isolate if positive, or if not you know you can go out and not infect anyone,” Tang said. With that in mind, OraSure is working to ensure the test is accurate.

Accuracy is the one drawback of antigen tests, said Dr. Amy Slenker, an infectious disease physician with Lehigh Valley Health Network, which has been working with OraSure on the tests. The COVID-19 antigen tests that are on the market now are more likely to give false negative results than the PCR (Polymerase chain reaction) tests that are the standard in clinical settings.

The PCR test looks for the genetic material of the virus and is generally more than 95% accurate, she said. Antigen tests that look for proteins from the virus, tend to be slower to pick up a positive.

“If I get a positive that’s great. That’s rapid results that I can act on, but I can’t trust it 100% if it’s negative because of the potential for a false negative,” Slenker said.

Many uses

In similar tests false negatives can occur anywhere between 50% and 90% of the time.

That’s why Tang said OraSure is working so hard to improve the sensitivity of its COVID-19 antigen tests to reduce the possibility of an unwanted false negative. Despite lower accuracy rate, Slenker said, the rapid, in-home antigen test has many uses.

“They could potentially bring some clarity to this pandemic. They’re easy to do in workplaces, in sports facilities or in schools and they’re relatively cheap,” she said.

A retail price has not been set for the COVID-19 test yet, but Tang noted that OraSure’s home HIV test sells for between $45 and $50 in stores.

As the company gets closer to releasing the test it is ramping up production dramatically. Tang recently announced OraSure will hire 177 new workers in manufacturing, quality control and regulatory affairs to help meet the expected demand.

He told Lehigh Valley Business that while the company is used to manufacturing tens of millions of tests per year, he expects there to be a demand for more than 30 million tests per week, a manufacturing goal he hopes to meet by the second quarter of 2021.

“This is a formidable project for us,” he said.

Still, his company is facing the same production challenges that others are facing from the pandemic.

Many executives and non-production staff members are working from home, and like every manufacturer extra steps need to be taken to protect those workers.

“We’re making sure they’re taking care of themselves, and their family and working to protect workers that have to be in the facility,” he said.

Even with the challenges, he said, morale is very high at the company right now.

“Everything that this company has done over its 20-year history has put us on the way to putting out this rapid COVID-19 test,” said Tang.