Medical Device Network on MSN

Roche’s test for Bordetella infections gains FDA clearance

Roche’s point-of-care polymerase chain reaction (PCR) test for pertussis and other Bordetella infections has received ...
Pharm Exec

FDA Grants Emergency Use Authorization to Roche’s Cobas Liat SARS-CoV-2, Influenza A/B, & RSV Nucleic Acid Test

The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab ...
PharmiWeb

Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic. 1 FDA CLIA-waived tests broaden access to ...
labmate-online.com

Roche receives FDA clearance, CLIA waiver, for cobas® liat tests to provide point of care diagnosis of STIs

Roche has been granted US Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection ...
Medical Device Network

Roche secures FDA EUA for PCR test

Roche plans to seek FDA 510(k) clearance for the test in the US. Credit: Louis Reed on Unsplash. Roche has received emergency use authorisation from the US Food and Drug Administration (FDA) for its ...
The Independent

20-minute flu test could save NHS up to £24m a year and free up beds, manufacturer says

From reproductive rights to climate change to Big Tech, The Independent is on the ground when the story is developing. Whether it's investigating the financials of Elon Musk's pro-Trump PAC or ...
Fierce Biotech

Roche's point-of-care whooping cough test greenlighted in US, Europe as cases surge

Designed for use in doctor’s offices, clinics and emergency rooms, the PCR diagnostic aims to deliver results in fewer than ...
PMLive

Roche receives FDA clearance for whooping cough test

Roche has received clearance from the US Food and Drug Administration (FDA) for its point of care diagnostic test for ...
Santé log

Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)

Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more precise care decisions.