A multicenter study led by Children’s Hospital Colorado finds that skin biopsy fibroblast assays can help diagnose primary mitochondrial diseases, potentially reducing the need for invasive muscle and liver biopsies.
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 Aptitude’s next-generation Metrix COVID Test, which the company says offers 3-fold higher sensitivity and 30% faster results compared to its EUA version.
Pillar Biosciences has introduced the oncoReveal Myeloid v2 Panel, expanding its NGS assay from 58 to 80 genes and enhancing FLT3-ITD detection while maintaining existing laboratory workflows.
The multiplex PCR assay detects 13 viral and bacterial respiratory pathogens from a swab.
General practitioner requests for AMH fertility tests rose more than 13-fold from 2011 to 2021, despite research showing these tests cannot predict natural conception, according to a Flinders University study of 1.4 million health records.
Werfen has launched a web-based platform designed to centralize autoimmune testing data, automate workflows, and integrate with laboratory information systems for high-volume clinical labs.
Siemens Healthineers has launched the FDA-cleared Innovance D-Dimer 2.0 assay, designed for rapid exclusion of DVT and PE in outpatients and optimized for STAT laboratory testing.
Lund University has received a $19.4 million NIH grant to clinically validate a new blood biomarker test for Alzheimer’s, assessing MTBR-tau243 and p-tau217 for improved disease staging and diagnostic accuracy.
Revvity has introduced the CE-IVDR-certified GSP T1D 3plex kit, a multiplex dried blood spot assay for early type 1 diabetes screening in children, designed to support population-level programs.
A Johns Hopkins study reports that adding three urine biomarkers to standard assessments raises the accuracy of predicting deceased donor kidney transplant success from 80% to 86%.
The Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards for detecting cystic fibrosis mutations.
Tampa General Hospital is the first in the Southeast to implement the MeMed BV host-response test in its emergency workflow, reporting a 33% reduction in cefepime use and 13% fewer hospitalizations, according to hospital-led research.