China’s NMPA has approved Quanterix and Innovita’s HD-X and SR-X immunoassay platforms and four blood-based neurology biomarker tests, expanding access to Alzheimer’s diagnostics in the Chinese clinical lab market.
Using microfluidic shear stress, the system detaches living cells from excised tissue to support pathology workflows and downstream diagnostic testing.
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.
An ancillary analysis of the phase III NRG/RTOG 0815 trial shows Veracyte’s Decipher Prostate test can predict which intermediate-risk prostate cancer patients benefit from adding hormone therapy to radiation.
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.
Garvan Institute researchers have developed a long-read nanopore DNA test that screens over 300 genes, diagnosing inherited muscle diseases in cases missed by standard testing.
Ambulance crews using point-of-care high-sensitivity troponin tests and the HEART score safely avoided ED transport for over one-third of chest pain patients, according to a study presented at the European Emergency Medicine Congress.
CND Life Sciences has opened a dedicated Innovation Laboratory in Scottsdale, Ariz., to expand assay development and biomarker research for neurodegenerative diseases, operating separately from its CLIA-certified clinical lab.
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.