Skip to content Skip to footer
Subscribe Now
Roche
NEWS

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Shots: Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help…
December 2, 2025

Read more

NEWS

Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinoma The OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib) OncoMate MSI Dx Analysis System…
November 12, 2025

Read more

NEWS

BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System

Shots: BD has received 510(k) clearance & CE Mark for its EBP & EBP plus panels on the BD COR System to detect gastrointestinal bacterial pathogens from a single stool swab using PCR-based testing EBP detects multiple enteric bacterial pathogens, incl. Salmonella, Campylobacter (jejuni, coli), Shigella/Enteroinvasive E. coli, & Shiga toxin-producing E. coli, while EBP plus…
November 4, 2025

Read more

Visby Medical
NEWS

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Shots: The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options Visby Medical Women's Sexual…
March 31, 2025

Read more

Viewpoints_Michael Scheffler
VIEWPOINTS

Michael Scheffler, Vice President, Head of Life Science PCR at QIAGEN Shares Insights on the Addition of New Biopharma Products to its Digital PCR Portfolio

Shots: Michael spoke about the addition of new biopharma products through QIAcuity series of digital PCR (dPCR) instruments to its digital PCR portfolio He also talked about how QIAGEN’s dPCR assays are quicker than systems as it was launched in four different master mixes allowing experiments leading to precise results The interview gives an understanding of…
October 12, 2022

Read more