Nasdaq

Axim Biotechnologies Files Pre-Submission With FDA for CLIA Waiver Pathway on Lactoferrin Point-of-Care Diagnostic Test

SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...
GEN

POC Testing Predicted to Transform Healthcare

Recent advances in portable and automated molecular diagnostic systems will address the previously unmet need for decentralized, point-of-care nucleic acid testing. Rapid, accurate diagnostic systems ...
East Oregonian

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your hand, ...
JD Supra

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...
Business Insider

Mesa Biotech Receives FDA 510(k) Clearance and CLIA Waiver for Its Accula™ RSV Molecular Point of Care Test

SAN DIEGO, Nov. 27, 2018 /PRNewswire/ -- Mesa Biotech Inc., is a privately held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) ...
Morningstar

binx health and WellStreet Urgent Care Increase Access to Chlamydia and Gonorrhea Testing and Care In-clinic

The program is powered by the binx io, an FDA-cleared, CLIA-waived, molecular PCR chlamydia and gonorrhea ~30-minute test for male and female patients. Together, WellStreet Urgent Care and binx health ...