Allarity Therapeutics Announces CLIA Certification, Clearing the Path for Advancing DRP® Testing for FDA Registration

Allarity Therapeutics is now poised to run its DRP® testing in-house in a CLIA-certified laboratory environmentThe FDA requires that ...
Nasdaq

QuidelOrtho's (QDEL) Rapid Antigen Test Gets CLIA Waiver

QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
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 ...
JD Supra

Molecular Testing Expansion in Pathology: Where Strategy, Validation and Oversight Intersect

Many pathology groups have a common misunderstanding when expanding into molecular testing: underestimating the operational burden of later ...
JD Supra

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
ascopubs.org

Clinical Utility of CLIA-Grade AR-V7 Testing in Patients With Metastatic Castration-Resistant Prostate Cancer

High Expression of FGD3, a Putative Regulator of Cell Morphology and Motility, Is Prognostic of Favorable Outcome in Multiple Cancers In all, 142 (95%) of 150 questionnaires were completed by 38 ...
GEN

TrovaGene to Buy MultiGen’s CLIA Lab to Bolster Infectious Disease Testing

Firm will configure MutliGen tests on transrenal platform. Molecular diagnostics firm TrovaGene is to acquire MultiGen Diagnostics’ CLIA-certified laboratory in return for 750,000 shares of TrovaGene ...
EurekAlert!

Amplified Sciences earns CLIA certification for its first test to assess pancreatic cancer risk

Amplified Sciences — led by CEO Diana Caldwell (right) and Chief Scientific Officer V. Jo Davisson — has received regulatory clearance under the federal Clinical Laboratory Improvement Amendments ...