IVD
|2 min read
Proposed Rapid Molecular Assay Illustrates Continued IVD Investment in Point-of-Care Testing
If cleared by the FDA, bioMérieux’s rapid vaginitis panel could bring a new option to physician offices
|2 min read
FDA Clears Roche Test to Identify PTEN Loss in Prostate Cancer, Expanding Access to Targeted Therapy
Roche’s VENTANA PTEN (SP218) IHC companion diagnostic detects PTEN-deficient tumors in prostate adenocarcinoma, helping guide eligibility for TRUQAP (capivasertib) combination treatment in metastatic disease
|3 min read
Leveraging Regulatory and Best Practices as a Foundation for Scalable Clinical NGS
From validating bioinformatics platforms to finding qualified partners, there are many strategies clinical labs can adopt to stay in compliance
|2 min read
Vanderbilt Researchers Leverage Liquid Biopsies to Predict Immunotherapy Response in High-Risk Breast Cancer Patients
New study utilizes RNA sequencing of peripheral blood to monitor T-cell activity, offering a potential alternative to invasive tissue biopsies for clinical laboratories and oncologists
|3 min read
Enhancing Transplant Success with Living Organ Donation and Advanced Diagnostics
As demand for organs grows, laboratory diagnostics remain central to donor evaluation and transplant success
|5 min read
Leveraging Regulatory Clarity in LDTs to Drive Laboratory Innovation
What steps should your lab take in response to shifting LDT oversight?
Updated |2 min read
AliveDx's MosaiQ® Platform Registered with FDA as Class II 510(k) Exempt, Enabling US Labs to Adopt High-Throughput Automated Immunoassay Testing
MosaiQ is a next-gen immunoassay platform delivering automated, multiplexed testing and actionable insights for complex conditions
|3 min read
Greener Clinical Lab Testing Now Within Reach: New Solutions from Siemens Healthineers
The Atellica instruments from Siemens Healthineers are now My Green Lab ACT Ecolabel certified
|2 min read
District Court Overturns FDA’s LDT Rule: What the Ruling Means for Clinical Labs Now
Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced
|3 min read
UK and European Experts Release Landmark Clinical Guidance for Breast Cancer Prevention
This new publication sets the standard, enabling more personalized and targeted breast cancer prevention and detection
|3 min read
Ensuring Quality Pediatric Care Through Laboratory-Developed Tests
ADLM congressional briefing explains the importance of laboratory developed tests for pediatric care and the FDA rule that will limit access to these critical tests
Updated |2 min read
What BD Selling Its Diagnostics Business Could Mean for Clinical Labs
Becton Dickinson’s plans will shift the IVD market and possibly create a stronger contender
|2 min read
