WASHINGTON, D.C. – The Food and Drug Administration announced Saturday that it has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as ...

(Reuters) - LabCorp said on Tuesday its at-home sample collection kit for COVID-19 testing would now be available to all individuals with symptoms and possible exposure to the virus, after limiting ...

A lab technician handles a test tube with a live sample from a person tested for the novel coronavirus. Photo: Andrew Milligan (Pool/AFP via Getty Images) The Food and Drug Administration (FDA) on ...

The U.S. Food and Drug Administration authorized the first at-home collection kits for novel coronavirus testing this week. The kits, made by the Burlington, N. C.–based company LabCorp, allow ...

The US approved a DIY nasal sample collection kit for coronavirus tests on Saturday, adding to an array of at-home options for a country eager to expand its COVID-19 testing. The Food and Drug ...

In recent days, the U.S. Food and Drug Administration's (FDA's) policy granting authorization to manufacturers and laboratories for desperately-needed COVID-19 test kits has created mass confusion and ...

The kit will be available only by prescription to individuals who have been screened using an online questionnaire that is reviewed by a healthcare provider. The Food and Drug Administration (FDA) has ...

EKF Diagnostics Holdings plc, the AIM listed point-of-care business, announces that it has received an initial order worth £3m from a partner from the private sector to supply PrimeStore MTM, a novel ...

(CNN) - The US Food and Drug Administration has given the green light for medical labs to test an at-home coronavirus sample kit. The FDA granted an emergency authorization to Everlywell Inc. for ...