A new federal directive tasks HHS with launching rapid diagnostic R&D for vector-borne diseases, emphasizing decentralized molecular testing as part of a broader strategy to improve local pathogen surveillance.
The FDA has cleared Qiagen’s QIAstat-Dx BCID GN Plus AMR Panel, enabling U.S. labs to detect 13 gram-negative bacterial pathogens and 18 resistance markers in about one hour on the QIAstat-Dx system.
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.
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Researchers have optimized the PROSPR method to isolate extracellular vesicles directly from whole blood, revealing protein and lipid signatures not detected in plasma.
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Researchers at Xuanwu Hospital have developed an ultrasonic blood test method that detects Alzheimer’s with over 90% accuracy by measuring plasma amyloid-beta seeding activity.
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Pillar Biosciences, LC-SCRUM-Asia, and LSI Medience will collaborate on a two-year, 2,000-patient liquid biopsy lung cancer screening project in Japan, using cfDNA and cfRNA testing.
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Researchers at CeMM and the Ludwig Boltzmann Institute have developed AI-based “tissue clocks” that estimate organ-specific biological age from blood samples, potentially improving chronic disease monitoring, according to a Nature Medicine study.
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Zepto Life Technology received up to $8.9 million from NIAID to develop a plasma cell-free DNA liquid biopsy platform aimed at improving diagnosis of invasive fungal infections.
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QIAGEN has received FDA clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, enabling detection of 20 pathogens and 10 antimicrobial resistance markers from positive blood cultures in about one hour.
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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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