UnitedHealth Group Covers Shield Blood Test for Colorectal Cancer Screening
The Shield test is now available to eligible members aged 45 and older, expanding access to screening options for colorectal cancer.
Category: Company News
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Quest Gains New York Approval for Haystack MRD Cancer Monitoring Test
The approval allows Quest Diagnostics to offer its minimal residual disease test for patients in all 50 states.
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Volta Labs Launches Automated Library Prep for Oxford Nanopore Sequencing Kits
The Callisto Sample Prep System application is optimized for the PromethION platform to support whole genome sequencing workflows.
Co-Diagnostics Develops Strategy for Ebola Bundibugyo Virus Assay
Co-Diagnostics has completed its assay development strategy for Bundibugyo virus, following the WHO’s emergency declaration and CDC’s updated traveler screening measures amid ongoing Ebola outbreaks in the DRC and Uganda.
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Tempus Launches AI-Powered Prostate Cancer Test for Metastatic Patients
Tempus has launched the ArteraAI Prostate Test, a CLIA-certified, CAP-accredited AI tool for metastatic hormone-sensitive prostate cancer, offering personalized risk estimates and designed to support treatment decisions, according to the company.
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FDA Approves Guardant Health’s New Blood-Based Cancer Test for Advanced Tumors
The FDA has approved Guardant360 Liquid CDx, a blood-based test that integrates genomic and epigenomic profiling for advanced cancer, offering a broader genomic footprint and faster results.
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TGen Launches 72-Hour Whole Genome Sequencing Test for Multiple Myeloma
TGen has launched JAYseq, a clinical whole genome sequencing test for multiple myeloma that delivers results in 72 hours, enabling rapid identification of genetic changes and immunotherapy targets, according to the institute.
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Cleveland Diagnostics Receives ISO Certification, Advancing Expansion for Prostate Cancer Test
Cleveland Diagnostics has received ISO 13485:2016 certification for its IsoPSA Assay, supporting scaled U.S. commercialization following recent FDA approval for prostate cancer risk assessment.
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FDA Clears Customizable Gastrointestinal Pathogen Assay
Diasorin has received FDA 510(k) clearance for its customizable LIAISON PLEX Gastrointestinal Flex Assay, allowing labs to select from 24 targets to tailor testing based on patient needs and operational priorities.
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Labcorp Launches AI-Powered App to Help Patients Understand Test Results
Labcorp has launched MyLabcorp, a mobile app that uses OpenAI models to help patients interpret lab results and track health trends. The company cites growing consumer demand for AI-powered health information and clinical context.
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Medicare Expands Coverage for Cancer Immunotherapy Monitoring Test
CMS has expanded Medicare coverage for Personalis’ NeXT Personal MRD test, now allowing immunotherapy monitoring in late-stage solid tumor patients, supported by recent clinical evidence from Vall d’Hebron Institute of Oncology.
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BillionToOne Launches Non-Invasive Prenatal Confirmation Test Using Fetal Cells
BillionToOne has launched Unity Confirm, a non-invasive prenatal test that isolates fetal cells from maternal blood to confirm high-risk screening results, addressing the gap between NIPT and invasive diagnostics.
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FDA Clears New Genomic Test for Solid Tumors
The FDA has cleared Datar Cancer Genetics’ CellDx-Tissue, a genomic profiling assay that analyzes 517 cancer-associated genes from solid tumor tissue to support clinical decision-making, according to the company.
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Caris Life Sciences Seeks New York State Authorization for Blood-Based Cancer Test
Caris Life Sciences has applied to the New York State Department of Health for authorization of Caris Assure, a blood-based molecular profiling test for cancer using whole exome and transcriptome sequencing of 22,000 genes.
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Amplified Sciences Launches Study for Pancreatic Cyst Diagnostic Assay
Amplified Sciences has launched the PanAMP multicenter study to assess how its PanCystPro assay impacts clinical management decisions for patients with radiographically confirmed pancreatic cystic lesions.
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Alzheimer’s Blood-Based Biomarker Testing Integrated into Clinical Workflows
Lucent Diagnostics and Tempus AI have partnered to integrate blood-based Alzheimer’s biomarker testing into clinical workflows, aiming to expand access and improve detection accuracy for neurologists.
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Roche Receives CE Mark for Alzheimer’s Disease Blood Test
Roche has received CE mark approval for its Elecsys pTau217 blood test, designed to aid in Alzheimer’s disease diagnosis by detecting amyloid pathology in patients with cognitive decline.
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Bio-Rad Expands Antibody Labeling Kits for Flow Cytometry and Western Blot
Bio-Rad has expanded its TrailBlazer StarBright Dye Label Kits to 32 options, now available in Europe for flow cytometry and fluorescent western blot applications, according to the company.
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