clinicaladvisor.com

First genotyping test approved for hep C

HealthDay News — The FDA has approved a new test to help healthcare providers identify the genotype of a person’s hepatitis C infection. The Abbott RealTime HCV ...
GEN

FDA Gives Nod to Abbott’s HCV Genotyping Test

FDA this week approved its first genotyping test for patients with hepatitis C virus (HCV), Abbott’s RealTime HCV Genotype II. The test can differentiate genotypes ...
GEN

FDA Gives Osmetech’s Cystic Fibrosis Genotyping Test a Thumbs Up

It can be used to screen adults as a method to detect the disease in progeny. Osmetech received FDA clearance for its eSensor® Cystic Fibrosis Genotyping Test for use on the eSensor® XT-8 System. This ...
FiercePharma

BioReference to Launch Groundbreaking Solid Tumor Genotyping Test through its GenPath Oncology Laboratory

ELMWOOD PARK, N.J.--(BUSINESS WIRE)-- BioReference Laboratories, Inc. (NASDAQ: BRLI) and its GenPath Oncology business unit and through its exclusive commercialization agreement with the Massachusetts ...
Labroots

Automation and Emerging Methods with New Guidelines for HPV Self-collection and Extended Genotyping w/ Live Q&A

The American Society for Colposcopy and Cervical Pathology (ASCCP) has issued new guidelines reflecting the importance of extended genotyping in HPV testing to support an enhanced standard of patient ...
FiercePharma

SaneVax Inc. Protests FDA Approval of Roche’s cobas HPV Genotyping Test

TROY, Mont.--(BUSINESS WIRE)-- In an April 22, 2011 letter to FDA Commissioner; Dr. Margaret Hamburg, Norma Erickson on behalf of the SaneVax Inc. Board of Directors, criticized the FDA for not ...
MobiHealthNews

Cue Health to develop Omicron genotyping COVID-19 test and other digital health briefs

Diagnostic company Cue Health announced on Thursday that it will create an Omicron-genotyping COVID-19 test. The test will be used in professional care settings to specifically detect the Omicron ...
Nature

Clinical relevance of partial HPV genotyping in cervical cancer screening

Partial human papillomavirus (HPV) genotyping is increasingly used to triage high-risk (HR)-HPV-positive women in national cervical cancer screening. This study evaluated whether separate triage for ...
Nasdaq

BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities

BD Onclarity™ HPV Assay is the only FDA-approved HPV assay to individually identify and report genotypes beyond 16, 18 and 45 FRANKLIN LAKES, N.J., July 22, 2020 /PRNewswire/ -- BD (Becton, Dickinson ...
Fierce Healthcare

BioReference to Launch Groundbreaking Solid Tumor Genotyping Test through its GenPath Oncology Laboratory

ELMWOOD PARK, N.J.--(BUSINESS WIRE)-- BioReference Laboratories, Inc. (NASDAQ: BRLI) and its GenPath Oncology business unit and through its exclusive commercialization agreement with the Massachusetts ...