- FDA announced Tuesday its first emergency use authorization for a coronavirus diagnostic test with an at-home sample collection option.
- The agency re-issued an EUA for LabCorp's COVID-19 molecular test, first given in early March, to permit testing of self-swabbed nasal specimens by individuals using the company's home collection service called Pixel. The unit already sells dozens of at-home test kits for conditions like diabetes and heart health.
- The move by FDA comes just a week after it emphasized it had not yet authorized any COVID-19 test for at-home collection, despite a slew of companies trying to market at-home products. The agency raised concerns over whether the average consumer could safely and correctly collect a specimen, but Commissioner Stephen Hahn said Tuesday LabCorp's kit is "as safe and accurate as sample collection at a doctor's office, hospital or other testing site."
The green light for the at-home test comes as the Trump administration and governors are scrambling to ramp up the nation's still insufficient COVID-19 testing capacity as states look to reopen society and their hard-hit economies. At the same time, public and private laboratories nationwide report shortages in the supply chain in getting the materials needed to run tests.
The at-home version of the test must be recommended by a healthcare provider after completing a questionnaire. The $119 price tag includes kit materials, overnight shipping, as well testing of the sample. Initially, the limited number of kits will be made available to "healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic," the company said. LabCorp did not specify the number of home test kits it's aiming to produce.
By switching from onsite clinician-collected to self-administered tests at home, LabCorp contends the healthcare system can reduce strain on clinicians who must use personal protective equipment and insert a swab in a patient's nasal cavity to collect a specimen.
LabCorp plans to make the tests available to consumers in most states, with a physician's order, in the coming weeks.
The company's kit contains nasal swabs and saline for collecting the nasal sample, which is mailed back in an insulated package for testing with results available in one to two days after it has been received by the lab.
Last week, FDA voiced several concerns about such at-home collection. On that list: "whether the components of the specimen transport media are safe for use in the home environment (since some may be toxic), proper shipment, and adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions (such as, if the specimen sits in a hot truck)."
However, the agency has given the nod to the shipping materials in LabCorp's kit and the company's ability to safely send samples to its lab. FDA also seems to have satisfied its previous concerns about whether consumers can safely and properly collect nasal specimens.
Still, according to the company, failure to collect an adequate sample or ship it within 24 hours of collection could compromise a lab's ability to run the test.
Although Hahn said LabCorp's kit is safe and accurate, he warned it's "not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home."