Strides forward for COVID-19 screening as FDA authorizes first consumer home collection kit, with OTC rapid test in the pipeline
The piecemeal move toward more broadly accessible COVID-19 testing took two steps forward, with the first FDA authorization for a direct-to-consumer home sample collection kit, and an EUA application for an over-the-counter rapid antigen test.
The U.S.’s move toward increasing asymptomatic COVID-19 screening to help prevent outbreaks has been limited by the requirement of some version of a doctor’s prescription in many cases, including for tests authorized for use entirely at home, or in asymptomatic populations.
On Wednesday, FDA authorized the Pixel COVID-19 Test Home Collection Kit from Laboratory Corp. of America Holdings (NYSE:LH) for use by any individual 18 years and older, without a prescription.
Samples collected at home are mailed to LabCorp. where they undergo polymerase chain reaction (PCR)-based testing. Positive and invalid results are communicated to the user via a phone call from a healthcare provider, while negative results are communicated electronically.
The same day, Brisbane-based diagnostics company Ellume announced it had submitted an emergency use authorization (EUA) application for an at-home COVID-19 rapid antigen test, with validation data in both symptomatic and asymptomatic users ages two and up.
In a simulated home-use study with 198 participants, the test had a 95% positive percent agreement with an authorized PCR-based test, a measure of sensitivity, and a 97% negative percent agreement, reflecting its specificity.
The test comes with a smartphone app that provides user instructions, displays results, and facilitates reporting. The fluorescent nanoparticle detection system, which involves optical sensors and incorporates multiple internal controls to minimize errors, is a miniaturized version of the technology used in the point-of-care immunoassay instrument from Quidel Corp. (NASDAQ:QDEL), Ellume founder and CEO Sean Parsons told BioCentury.
He said that in terms of scalability and control of interpretation of results, Ellume’s COVID-19 antigen test sits in between Quidel’s Lyra, which is read out by the company’s Sofia instrument, and the Abbott Laboratories (NYSE:ABT) BinaxNOW, which consists of a stand-alone lateral flow “card” that is read by the user.
Ellume’s test will cost about $30; BinaxNOW costs about $5. The Australian company, which has its second headquarters in California, has a home flu test partnered with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) under review by FDA.
Ellume received a $30 million grant from NIH’s Rapid Acceleration of Diagnostics (RADx) initiative to scale up manufacturing. It plans to ship more than 100,000 at-home tests per day in December, and deliver 20 million tests to the U.S. in 1H21.