Latest Headlines
-
QIAGEN Enhances Bioinformatics Workflows With New Secondary Analysis Solution For Oncology And Inherited Disease Applications
5/2/2024
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the availability of QCI Secondary Analysis, a cloud-based software-as-a-services (SaaS) solution enabling high-throughput secondary analysis for use with any clinical next-generation sequencing (NGS) data.
-
Valar Labs Announces Validation Of First Histology-Based Test To Predict Response To BCG In Bladder Cancer
5/1/2024
Valar Labs, the developer of computational histology AI tests for predicting response to cancer therapies, announced new data today which is being presented on Saturday, May 4, 2024 at the 2024 Annual Meeting of the American Urological Association (AUA) as a podium presentation (PD30-03).
-
Concert Expands Diagnostic Benefit Program To Manage Laboratory Testing For Health Plans
5/1/2024
Concert has expanded its Diagnostic Benefit Program, formerly known as the Genetics Benefit Program, to provide payment and clinical policies and payment accuracy capabilities across routine and advanced laboratory testing, enabling health plans to provide their members with access to these important clinical services at lower total costs, the company announced today.
-
Quest Diagnostics To Acquire PathAI Diagnostics To Accelerate AI And Digital Pathology Adoption In Cancer Diagnosis; Forms Licensing Agreements With PathAI
5/1/2024
Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, and PathAI, a global provider of artificial intelligence-powered technology for pathology, today announced a multi-faceted collaboration designed to accelerate the adoption of digital and AI pathology innovations to improve quality, speed and efficiency in diagnosing cancer and other diseases.
-
Lyric And Concert Expand Partnership To Deliver Laboratory Payment Accuracy Solution
5/1/2024
Lyric, an AI-first leader in payment accuracy, has expanded its partnership with Concert to deliver payment accuracy across a rapidly expanding set of advanced and routine laboratory tests, the companies announced today.
-
AdvaMed Statement On The Release Of FDA Rule On Laboratory-Developed Tests
4/29/2024
Today, AdvaMed, the Medtech Association, released the following statements from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s final rule for Laboratory Developed Tests (LDTs):
-
GenomOncology Introduces Expanded Support For Germline Testing In GO Pathology Workbench
4/29/2024
GenomOncology (GO) revealed today an upgraded version of GO Pathology Workbench, their software platform for tertiary analysis and reporting of next generation sequencing (NGS) and other molecular testing results.
-
Labcorp Receives FDA Approval For First Companion Diagnostic For Use With Pfizer's Newly Approved Gene Therapy To Treat Patients With Hemophilia B
4/29/2024
Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy.
-
The Association For Diagnostics & Laboratory Medicine (Formerly AACC) Opposes FDA Ruling On Laboratory Developed Tests; Urges FDA To Involve All Stakeholders In Modernization Of Laboratory Developed Test Regulation In Order To Preserve Patient Access To V
4/29/2024
"We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) strongly disagree with the Food and Drug Administration's (FDA's) decision to issue a final rule placing laboratory developed tests under duplicative FDA authority, in addition to these tests' current regulation under the Centers for Medicare & Medicaid Services (CMS).
-
FDA Takes Action Aimed At Helping To Ensure The Safety And Effectiveness Of Laboratory Developed Tests
4/29/2024
Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.