Editor's note: Since the publication of this story, the FDA has released an alert warning that it "has not authorized any test that is available to purchase for testing yourself at home for COVID-19." MobiHealthNews has reached out to Scanwell Health, myLAB Box and others about their at-home services: read the updated story here.
Scanwell Health and myLAB Box are the two latest at-home diagnostics services to address the shortage of COVID-19 testing in the U.S., the companies recently announced. Both anticipate their testing kits to be available within the coming weeks.
The former, a startup best known for its smartphone-based urinary tract infection screening platform, has purchased the exclusive rights to license and distribute a serology test from Chinese firm INNOVITA. This technology – the only rapid serology test cleared by China's National Medical Products Administration – can be conducted at the consumer's home with the assistance of the Scanwell Health App.
Scanwell is planning to distribute these tests to consumers who have taken an online intake questionnaire through its telehealth partner Lemonaid Health. If approved, a Lemonaid provider will have the test mailed to the patient. The test can be completed and uploaded through the app within 15 minutes, according to the company, with patients receiving their results from the Lemonaid provider "within hours."
“We recognized that a number of healthcare organizations are struggling to evaluate patients for COVID-19 due to testing constraints,” Stephen Chen, founder and CEO of Scanwell Health, said in a statement. “While the gold standard for diagnosis is still the PCR test, given the growing shortage of swabs and reagents, a rapid serology test is beneficial in that it allows for wide-scale testing.”
The rapid serology test Scanwell is supplying demonstrated 87.3% sensitivity and 100% specificity compared to traditional tests in a Chinese clinical trial, the company said.
Scanwell is currently seeking Emergency Use Authorization from the FDA, but anticipates that the service will be available within six to eight weeks in Washington, California, New York and "other severely affected states." It's targeting a price of $70 (which includes next-business-day delivery), and looking at options for those unable to pay.
Meanwhile, myLAB Box, which offers a broad range of mail-order, at-home testing kits, announced this week that it has opened pre-sales of its more traditional COVID-19 home test for "all professional entities such as clinics, doctor’s offices, pharmacies and more," with plans for a direct-to-consumer rollout in the pipeline.
These tests would require no pre-screening to order, and only require the patient to self-collect a saliva – not a nasopharyngeal – swab sample. These samples are to be overnighted to a Clinical Laboratory Improvement Amendments (CLIA) certified, 24/7 testing lab, with results delivered one or two days from the time of shipment to the lab. myLAB Box also said that free telemedicine consultations will be made available to those who test positive for the virus.
myLAB Box said that it will be ramping up its testing capabilities over time, but is targeting up to 20,000 processed tests per day.
"The WHO and CDC agree that testing is the foundation of an effective public health response to save lives," Lora Ivanova, CEO and cofounder of myLAB Box, said in a statement. "By opening sales to professional healthcare providers first we aim to alleviate some of the challenges they are struggling with, allowing them to better serve their patients anytime and anywhere."
WHY IT MATTERS
The U.S. response to the COVID-19 pandemic has been hamstrung by widespread testing shortages, with a report from Oxford University's Our World in Data suggesting per capita testing rates 40 times lower than those of South Korea.
The provision of additional COVID-19 diagnostic tests of any kind will help healthcare teams better prioritize the highest-risk patients, while informing others of the need to self-isolate. At-home testing options can be particularly effective in this regard by preventing yet-undiagnosed patients from unnecessary community exposure.
“The option of having an at-home test mailed next day to your door gives Americans nationally a new option for how to get tested without putting others at risk of infection by driving to a lab or doctor’s office,” Paul Johnson, CEO and cofounder of Lemonaid Health, said in a statement. “Our medical team will order the test, convey the results to the patient, and help the patient understand what the test result means in terms of both the result and what to do next. The result of the test could have immediate implications for not just the patient, but their family and friends, too.”
THE LARGER TREND
The announcements of Scanwell and myLAB Box's home diagnostic offerings come alongside word from EverlyWell and Nurx of similar services. EverlyWell's kits are set to launch on Monday to the tune of 30,000 additional U.S. tests, while Nurx is aiming to provide telehealth consultations and home-testing services "within the week."
A substantial number of digital health, telehealth and direct-to-consumer efforts have emerged over the last few months as global healthcare systems find themselves overwhelmed by the pandemic. These efforts range from data-driven disease-tracking to app-based surveying to online triage and testing.