Startup Offers $181 At-Home Virus Tests, FDA Says Not So Fast

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The startup Nurx Inc. is best known for selling birth control online that’s delivered to customers’ front doors. But when it realized the gravity of the novel coronavirus that’s quickly spread across the globe, the San Francisco-based company saw an opening. It began pouring resources into offering at-home tests for Covid-19, the disease caused by the virus.

“Where are our patients? They’re at home,” says Chris Hall, a clinical adviser to Nurx. “We think it’s ideal to pivot our platform to be able to offer not only a home test, but a home consultation service that provides support to patients to help them make their own triage decisions.”

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A severe and unexpected shortage of Covid-19 tests in the U.S. and a sharp increase in infected people created a gaping opportunity for a slew of young telehealth companies trying to bring the digital medical experience home. The highly contagious and sometimes deadly disease has meant a rush of patients eager to steer clear of overcrowded urgent care centers and doctor’s offices. And for nimble upstarts, taking advantage of that increased demand has at times meant quickly shifting focus from birth control and Viagra to infectious disease.

In past efforts to turn health care into a quick, convenient consumer experience, many such startups waded into controversy. The coronavirus experience is proving no different, even as the White House pushes for innovation. As companies flood the market with coronavirus tests, symptom-checking chatbots, and medicine-prescribing services, they’ve already drawn objections from federal regulators wary of Silicon Valley’s speed.

On March 20, Nurx launched its $181 home test, which required patients to collect a throat swab themselves and mail it to a lab. The company planned to make more than 10,000 of them available in coming weeks. But the same day the U.S. Food and Drug Administration warned that it had “not authorized any test that is available to purchase for testing yourself at home for Covid-19.” The following day the regulator clarified that leeway given to test developers to rapidly begin processing Covid-19 tests didn’t apply to at-home testing. Nurx pulled its tests from the market.

At-home testing requiring self-collection of samples isn’t currently recommended, an FDA spokesman explained, because of concerns about everything from materials used to collect patient samples to preserving specimens and transporting them.

In the U.S., there's been a push to make testing more widely available and accessible, including the recent approval of an Abbott Laboratories test, targeted initially at hospitals and clinics, that is small and portable and can tell if someone is infected in as little as five minutes. At-home lab tests appear to have attracted an additional layer of scrutiny from regulators, though, because they operate outside of a health-care setting.

Some telehealth startups, from Nurx (pronounced NUR-ex) to Everlywell Inc. and Ro, have faced criticism for their attempts to disrupt the highly regulated health-care industry. Ro and Hims Inc., both men’s health sites, have been accused by others in the medical community of doling out prescriptions too readily and potentially flouting guidelines about marketing drugs for uses other than those for which they’ve been approved. Both companies have insisted they have strict standards for prescribing drugs but aim to make access to care more widespread. Nurx has also raised questions about some of its unusual practices. A report by the New York Times last year cited former employees describing some executives’ efforts to loosen standards for prescribing birth control, and shipping out pills that had been returned after being unsuccessfully delivered to patients from partner pharmacies. Nurx said the practice of reshipping pills ended nearly two years ago and affected only a tiny fraction of orders. The company also said it has since hired a new slate of executives, including a vice president of pharmacy, and is confident that they are following the appropriate processes.

With urgent demand to scale up testing and make online doctor visits and consultations more accessible, the companies are trying to thread the needle between a push for solutions and public safety. The U.S. Centers for Disease Control and Prevention, the national public-health institute, has urged the health-care system to embrace virtual doctor visits and self-assessment tools to help mitigate the burden of Covid-19 on hospitals and reduce opportunities for disease transmission.

The Trump administration has also relaxed certain requirements to make telehealth more accessible, including to people on Medicare, the federal program for seniors and people with disabilities. Almost overnight, telehealth companies have reported that the number of patients they’re seeing each day has as much as doubled.

On March 4, telehealth company Ro, which runs Roman, an online men’s health clinic known for its cheap prescriptions for generic Viagra, launched a digital tool that focuses on the coronavirus. Designed as an online quiz, it aims to help evaluate symptoms and connect users with a virtual doctor if necessary. “It’s about buying our health-care system time,” says Zachariah Reitano, co-founder and chief executive officer of Ro. “What telemedicine can do is triage at scale. This is the moment people are realizing the tremendous benefit that telehealth can have.”

Hims, a startup for men that offers hair loss treatments and cheap, fast online prescriptions for erectile dysfunction and premature ejaculation drugs, has expanded to offer primary care services online for $39 a visit. “Just because we’re all at home doesn’t mean we can’t pick up a cold from one of our kids,” says founder and CEO Andrew Dudum.

As news of the virus grew more dire, he says, a small team of Hims employees rushed to build the primary care service over the course of just one week, all while working remotely. “It’s been pretty much wartime here,” he says. The service offers consultations on more than 30 common conditions and prescription medicine.

Other telehealth companies have sought to cash in on the demand for medications that may have the potential to treat the virus. DocTalkGo, an online urgent care center, recently launched a website that for $89 will assess symptoms of Covid-19 and issue a prescription for hydroxychloroquine, an antimalarial drug being tested to treat the virus. However, only very small, early-stage studies have suggested the drug might be effective in treating Covid-19, even though the idea has attracted endorsements from influential figures including Tesla Inc. CEO Elon Musk and President Trump.

The FDA continues to work with developers on authorizations of at-home tests. Lemonaid Health, which offers online treatment for everything from depression to the flu, recently said it would begin offering at-home testing in partnership with Scanwell Health once Scanwell’s lab gets FDA approval. The test would be based on a blood sample rather than a mucus swab. Competition is fierce: Everlywell, which had been best known for controversial tests for food sensitivity, put aside $1 million to dole out in incentives to laboratories that could quickly begin processing Covid-19 tests.

In developing its home test kit, Austin-based Everlywell has had to consider issues that could crop up, including precautions to prevent users from reselling tests, says CEO Julia Cheek. Everlywell aimed to make its test kits available on March 23 for $135. About 30,000 tests would initially be available, with the goal of testing and diagnosing about 250,000 people each week.

However, in the days before its tests were supposed to be available to the public and as the FDA cracked down, Everlywell changed its plans. For now, its Covid-19 test will be available to “healthcare companies with workers on the front lines in order to get these tests in the hands of those who need them most urgently,” the company said in a statement.

It hopes to gain approval for general consumer testing soon, but with regulators already stretched thin, there’s no telling how long that might be.

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