OGT has expanded its SureSeq Universal NGS Unique Dual Index portfolio, enabling up to 384 uniquely indexed samples per run on Illumina platforms, quadrupling previous capacity and supporting higher-throughput workflows, according to the company.
A University of Washington study found the panel cross-reacts with 78 gut bacteria species, resulting in over 250,000 false-positive norovirus results since 2019.
A federal court ordered Guardant Health to pay more than $245 million to TwinStrand Biosciences and the University of Washington in a patent infringement case. Guardant Health is appealing the judgment.
Researchers at MUSC Hollings Cancer Center have developed the ADLiB liquid biopsy platform, which uses machine learning to prioritize lymphoma diagnosis, identifying high-risk patients with up to 95% accuracy.
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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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Caris Life Sciences has launched in-house PTEN IHC testing to identify prostate cancer patients eligible for FDA-approved, biomarker-guided therapy, supporting precision treatment for PTEN-deficient mAPMN/S prostate cancer.
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The Enhancing CLIA Act, introduced in Congress as H.R. 8890, proposes modernizing the CLIA framework for laboratory-developed tests and reaffirms CMS—not FDA—oversight of LDTs, signaling potential regulatory changes for labs.
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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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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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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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YD Bio and Numia Health have launched a six-month pilot in British Columbia to evaluate cross-border blood-based cancer testing, supporting up to 50 patient episodes with laboratory analysis performed at a CLIA-certified U.S. facility.
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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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The funding will support regulatory certification and the commercial launch of rapid tests for Lyme disease and sexually transmitted infections.
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As Cyclospora infections surge in the US, laboratories face increased pressure to quickly differentiate cases, with the CDC reporting 1,947 confirmed infections and 98 hospitalizations across nine states as of July 24.
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The FDA has cleared Roche’s cobas BV/CV assay, a molecular test that detects bacterial vaginosis and Candida vaginitis from a single swab, enabling streamlined diagnosis on the cobas platform, according to Roche.
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New analysis suggests that higher-sensitivity testing could lower annual spending by more than $3 billion by reducing misdiagnosis.
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The program connects researchers with certified laboratories offering single-molecule PCR testing, technical support, and bioinformatics expertise.
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