The Food and Drug Administration has given emergency authorization for the use of an at-home testing kit manufactured by the Laboratory Corp of America (NYSE: LH). The testing kit functions identically to those used by doctors and should be available to consumers very soon.
The FDA granted an emergency use authorization to LabCorp to manufacture and distribute the testing kit. The emergency authorization is a special approval given when no FDA approved solutions are available. LabCorp had, however, submitted data proving the safety and effectiveness of the kit before approval.
"With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home," said FDA Commissioner Stephen Hahn of the emergency authorization.
The test functions much like those used by doctors in that patients conduct a nasal swab. Patients can perform their own swab within the comfort of their own home before mailing the sample back to LabCorp for testing.
LabCorp has stated that it intends to make the testing kits available to first responders and healthcare workers immediately but announced that testing kits should become available to consumers in the coming weeks. The cost for a kit must be paid out of pocket, with the cost of each testing kit totaling $119. Those who wish to purchase a testing kit must obtain a doctor's order first, according to the FDA.
The test is expected to greatly aid in efforts to identify Coronavirus carriers and limit the spread of the virus. Additionally, because testing occurs at home rather than a clinic or dedicating testing site, no PPE is required to use the kit, which could help ease the strained supply of gloves, masks, and other protective equipment. The kit also negates the risk of medical workers becoming infected by carriers during the process of collecting samples from patients.
"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," the FDA said.