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Image: FDA approval enables the OncoMate MSI Dx Analysis System to identify patients who may benefit from Merck’s KEYTRUDA anti-PD-1 therapy. (Photo courtesy of Promega)

Microsatellite Instability Test Gains FDA Approval for Immunotherapy Selection

A new PCR-based test gains FDA approval to identify MSI-high solid tumors and help guide KEYTRUDA treatment. More...
11 Nov 2026
Image: The collaboration aims to expand access to the technology through a regulated clinical diagnostics pathway in Japan.

Partnership Aims to Bring Blood-Based Alzheimer’s Testing to Japan

C2N Diagnostics and LSI Medience have partnered to seek approval and commercialize the PrecivityAD2 test in Japan. More...
11 Nov 2026
Graphical overview of the study design and colorectal cancer risk stratification using blood-detected mosaic chromosomal alterations (mCAs). The schematic summarizes mCA detection and genomic features, factors associated with mCA carriage, and the integration of mCAs with germline polygenic risk and lifestyle factors for colorectal cancer risk assessment. (Image Credit: ©Science Bulletin)

Blood-Detected Chromosomal Changes May Refine Colorectal Cancer Risk Assessment

New data show blood-detected mosaic chromosomal changes refine colorectal cancer risk stratification beyond genetics and lifestyle. More...
11 Nov 2026
Image: The panel expands Cepheid’s respiratory testing portfolio on the GeneXpert platform, offering laboratories greater flexibility in selecting tests based on clinical needs. (Photo courtesy of Cepheid)

Multiplex PCR Test Gains CE Marking to Support Respiratory Infection Diagnosis

A new multiplex PCR test gains CE-IVDR marking, enabling rapid single-sample detection of 13 respiratory pathogens. More...
11 Nov 2026
Image Credit: Adobe Stock

AI Tool Automates Variant Curation and Interpretation for Cancer Whole-Genome Sequencing

Inocras is presenting the first public results from its multimodal agentic AI framework at the AMP 2026 Annual Meeting & Expo. More...
11 Nov 2026
Image: Figure 1 from Lim J, et al. “Amplification of RNA for Identification of Zika and HCV in Whole Blood.” Science Advances, 2026. https://doi.org/10.1126/sciadv.aeb6129. Licensed under CC BY-NC 4.0. Created in BioRender: https://BioRender.com/mr4p5qy.

Portable Test Detects Zika and Hepatitis C RNA from Whole Blood

A new test detects Zika and HCV RNA directly from whole blood at point of care in hours without lab equipment. More...
11 Nov 2026
Image: VITEK PRO combines microbial identification and antimicrobial susceptibility testing on a single platform to support routine microbiology workflows and antibiotic selection. (Photo courtesy of bioMérieux)

Automated Microbial Identification and Susceptibility System Gains FDA Clearance

bioMérieux has received FDA 510(k) clearance and IVDR CE marking for VITEK PRO, its new automated microbial ID/AST system. More...
11 Nov 2026
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