|04.21.20| FDA greenlights first home testing kit for COVID-19; Digital ventilator training tool for doctors

Thanks to an updated emergency use authorization (EUA) from the FDA, LabCorp's COVID-19 RT-PCR test is now the first diagnostic test for COVID-19 that permits at-home sample collection.

Now, patients may use Q-tip-style nasal cotton swabs and saline included in LabCorp's designated self-collection kit – which the company is branding as the "Pixel by LabCorp COVID-19 Test." These samples are mailed to a LabCorp facility in an insulated package for molecular testing.

LabCorp said in an announcement that it will initially be releasing these kits to healthcare workers and first responders with symptoms of COVID-19 or potential exposure to the virus. For consumers, the self-collection kits will be available in "most states" in the coming weeks, and will require a doctor's order, according to the FDA.

"For tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site," FDA Commissioner Dr. Stephen M. Hahn said in a statement. "With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The FDA stressed that this EUA only applies to LabCorp's offering, and does not apply broadly to other at-home COVID-19 sample collection products. The agency also said that it is looking into whether Q-tip-style cotton swabs such as these might be used to safely and effectively collect samples for other diagnostic tests.

WHY IT MATTERS

The U.S. is months into its battle against COVID-19 and still faces widespread testing shortages. While any new diagnostic tests for the disease will help healthcare teams better prioritize the highest-risk patients, an at-home sample collection option allows individuals to understand their condition without exposing anyone else in their communities.

As such, today's FDA authorization is a major step toward increasing access and limiting new infections among the public and healthcare workers alike. Time will tell whether other authorized molecular tests will receive similar authorizations – or whether providers may be able to avoid contact with symptomatic patients altogether by ordering these tests for their patients via telehealth.

THE LARGER TREND

Demand for at-home COVID-19 diagnostics has been clear for some time, particularly in mid-March when a spate of companies announced new home sample-collection services for molecular testing. However, each was forced to pump the brakes when the FDA clarified its policy and warned consumers that no such tests had yet been authorized. Many of these companies highlighted the ambiguity of the agency's guidance, but adjusted or axed their offerings to fall in line with regulatory requirements.

Similar confusions came to light among those developing serology tests for the disease in early April, with at least one company mistaking its response from the agency as an EUA and falsely marketing its service. It wasn't long after that Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test received the first authentic EUA for a COVID-19 serology test.

ON THE RECORD

"LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” Adam Schechter, president and CEO of LabCorp, said in a statement. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”

In the innovation circuit it’s hard to miss the array of new technologies seeking to address the coronavirus pandemic.

“It felt like there was a whole lot of duplications and a whole lot of innovation going on in silos,” Neil Patel, president of Healthbox and executive vice president of HIMSS, told MobiHealthNews.

He was even seeing these efforts first-hand. Patel explained that his wife is an ER doctor and when the coronavirus began she began collaborating on testing efforts with other providers in her area.

“And I just started thinking how many of these calls are going on around the country?” Patel said. “I love that there is so much collaboration going on, but there has to be a role for HIMSS to play here in making this much more efficient and helping people spread their ideas and things that they’d done more efficiently.”

That was when he came up with the idea for the HIMSS COVID-19 Digital Think Tank, an online discussion forum, which allows healthcare professionals and innovators to share ideas, products and best practices.

“We felt like the best way we could help in this pandemic is to connect people working on interesting things and to help them share their innovations,”

To date, they’ve had 550 individuals create accounts and 60 people have submitted innovations. Patel said that the goal is to have more people consuming ideas than posting.

“We’re seeing a good mix of solutions that technology companies have created and most of them if not all of them are being provided for free, which I think also is a good sign of companies just feeling like they have something to give and seeing it as a sense of public service,” Patel said.

He noted that this is actually an opportunity for startups to get seen and show the value in their products.

“It’s not a bad business idea either. Some of the hardest things in digital health [are] getting stickiness and getting adoption,” he said. “So, if you can engineer some of that by getting people to adopt it at this time when there is a willingness to do so and then you give it to people to start using it and it gets sticky. Then once you get past this crisis moment it’s like 'How do I even do my work without this?' Then you have a potential to be able to sell.”

This pandemic has been the catalyst for adoption of digital tools, he said. Today all hospitals are prioritizing the same issue: coronavirus, he said. This can help innovators understand

“So, I think you can say 'What are the top 10 health systems going to be prioritizing over the next 18 months that they weren’t prioritizing before, and that are post-COVID impacts?' and kind of segment to those,” he said.

With the world united in the goal of overcoming coronavirus, he said that this initiative is just another way to help connections.

“I think there is a role for a platform to be able to bring people together,” he said. “My worry is that this is like lightning in a bottle a little bit. I don’t mean it in a good way at all but what are all the things that had to align for this to happen. It’s kind of like the push that was needed but no one wanted it to be like this.”