Healio

FDA grants emergency use authorization to first mpox PCR home test

Please provide your email address to receive an email when new articles are posted on . Labcorp has received FDA emergency use authorization for its Mpox PCR Test Home Collection Kit. This test is now ...
Business Wire

Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs

SAN JOSE, Calif.--(BUSINESS WIRE)--Today, Visby Medical announced two new relationships that will expand national access to the Visby Women’s Sexual Health Test, the first, at-home, FDA-authorized PCR ...
MedCity News

PCR Comes to the Home With FDA Authorization of Visby’s OTC Sexual Health Test

PCR is a mainstay in diagnostics, but whether a sample is collected at a clinic or at home, such tests require sending a sample to a lab and then waiting for results. A new FDA authorized ...
The Digital Universe

BYU team helps create diagnostic tool that achieves accuracy of PCR tests with faster, simpler nanopore system

Over the past four years, many of us have become accustomed to a swab up the nose to test for COVID-19, using at-home rapid antigen tests or the more accurate clinic-provided PCR tests with a longer ...

AMDI™ Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel

Autonomous Medical Devices Incorporated (AMDI) today announced that the U.S. Food and Drug Administration has granted both ...
news.ucsc

New diagnostic tool achieves accuracy of PCR tests with faster and simpler nanopore system

Over the past four years, many of us have become accustomed to a swab up the nose to test for COVID-19, using at-home rapid antigen tests or the more accurate clinic-provided PCR tests with a longer ...