Researchers from the PRECISE-SG100K study have identified over 2,500 new genetic-protein associations by analyzing data from 10,000 participants, advancing biomarker discovery in large-scale, multi-ethnic cohorts.
MolDX has proposed a draft Local Coverage Determination to establish Medicare coverage criteria for optical genome mapping in hematologic neoplasms, with public comment open through Oct. 11, 2026, according to Bionano Laboratories.
QIAGEN has launched QIAsymphony Connect, an IVD-compliant platform for automated nucleic acid extraction, supporting up to 96 samples per run and compatible with existing QIAsymphony reagents and consumables.
The FDA will review GRAIL’s Premarket Approval application for the Galleri multi-cancer early detection blood test on Sept 23, 2026, evaluating data from the PATHFINDER 2 and NHS-Galleri studies.
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VolitionRx has published peer-reviewed data on its Capture-Seq technology, reporting over 99% pure ctDNA isolation from plasma and 95% detection of early-stage cancers in validation cohorts.
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Cancer Cell Diagnostics has launched the CellSight DNA test, a liquid biopsy that isolates intact circulating tumor cells for genomic profiling from a single blood draw, enabling analysis of over 500 genes and key biomarkers.
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Concert has issued a coverage policy deeming the EsoGuard Esophageal DNA Test medically necessary for eligible patients, with multiple client health plans now adopting the policy.
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Co-Diagnostics has submitted a Dual 510(k) and CLIA waiver application to the FDA for its PCR-based flu and RSV test, aiming to enable point-of-care use on the Co-Dx PCR Pro instrument.
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Roche has launched two new research PCR assays for Cyclospora cayetanensis detection, expanding lab testing options amid a US outbreak and adding flexibility for gastrointestinal pathogen research.
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SOPHiA GENETICS and AstraZeneca have signed a multi-year agreement to develop and deploy decentralized companion diagnostics for solid tumors and blood cancers, aiming to expand local lab access to precision oncology testing.
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Clinical labs are adopting broader cancer diagnostics—including whole-genome sequencing and multi-omic testing—to deliver more comprehensive molecular insights and improve disease monitoring.
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Researchers at Johns Hopkins validated an AI-powered blood test that accurately detects liver cancer in diverse populations, using the DELFI platform to analyze cell-free DNA fragments.
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GenomOncology and PacBio have introduced an integrated workflow for somatic whole-genome sequencing in oncology, combining PacBio’s HiFi WGS analysis with GenomOncology’s reporting platform for standardized clinical lab reporting.
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10x Genomics and Lausanne University Hospital have begun a multi-year study using single cell and spatial technologies to identify biomarkers predicting treatment response in patients with advanced solid tumors.
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Alveo Technologies and UTMB have partnered to develop point-of-care diagnostics for Lassa fever, deploying molecular sensing platforms at clinical sites in Nigeria and Sierra Leone to support real-time pathogen detection.
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HerAnova Lifesciences reported real-world data on its HerResolve multi-omic blood test for endometriosis at the 2026 Midwest Reproductive Annual Symposium, showing consistent performance across 197 cases in diverse clinical settings.
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OnsiteGene has unveiled myNAT, a handheld, battery-powered real-time PCR instrument capable of 40-cycle runs in under 10 minutes, with a target cost of under $5 per test, according to the company.
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RNA-based testing improves detection of MET exon 14 skipping in NSCLC, identifying mutations missed by DNA-only assays, according to new research. Findings may impact eligibility for targeted therapies.
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