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.
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 ...
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 ...

LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System

Ultra-fast point-of-care molecular diagnostics platform for key respiratory pathogens delivers results in under ten minutesCAMBRIDGE, United Kingdom, Feb. 16, 2026 (GLOBE NEWSWIRE) -- LEX Diagnostics, ...
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 ...
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 ...
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 ...
Seeking Alpha

Roche's first respiratory test powered by TAGS technology receives FDA clearance for SARS-CoV-2, Influenza A, Influenza B and RSV

Used with the cobas ® 5800, 6800 and 8800 systems, cobas Respiratory 4-flex simultaneously detects and differentiates the four most common respiratory viruses, helping to ensure confidence in ...
The Financial

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

The FINANCIAL — Roche on September 22 announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test ...