GlobalData on MSN

LEX Diagnostics secures FDA clearance for VELO PCR system

The system is intended for use in urgent care clinics, primary care settings, physician office laboratories, and pharmacies.
Verywell Health on MSN

PCR vs. rapid test for COVID-19: Which should you take?

Medically reviewed by Jordana Haber Hazan, MD Key Takeaways PCR tests are very accurate and can find the virus even in people without symptoms.Rapid tests can be done at home and show results in ...
Healio

FDA-cleared GI test detects ‘most likely causes’ of diarrheal syndromes

The FDA has cleared a multiplex polymerase chain reaction test designed to detect 11 clinically relevant gastrointestinal pathogens from a single stool sample.The Xpert GI Panel (Cepheid) can identify ...
ABC7 San Francisco

FDA authorizes first breath test to detect COVID-19

WASHINGTON -- The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency ...
360Dx

Lex Dx Wins FDA 510(k) Clearance, CLIA Waiver for Point-of-Care PCR System, Respiratory Test

NEW YORK – Lex Diagnostics said on Monday that it has obtained 510 (k) clearance and CLIA waiver from the US Food and Drug Administration for its Velo point-of-care molecular diagnostic system and an ...
6abc News

FDA authorizes 1st COVID-19 antigen test, which produces results within minutes

The Food and Drug Administration has authorized emergency use of the first antigen coronavirus test, which produces results within minutes and is relatively cheap to make, according to the agency. The ...
Medscape

FDA Approves Genetic Test for KRAS Mutation in CRC Patients

July 6, 2012 — The US Food and Drug Administration (FDA) has approved the therascreen® KRAS RGQ PCR Kit to be sold as a companion diagnostic test for cetuximab (Erbitux). In addition, the FDA has ...
Morningstar

Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™ PCR Platform to Support Submission to the U.S. FDA

SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ --Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of ...
Fierce Biotech

Thermo Fisher unveils test to aid in dosing of antirejection drug

Thermo Fisher Scientific is launching a new test it says can help doctors avoid the “trial-and-error” approach typically used ...