Researchers found high-grade precancerous lesions or cervical cancer in 12 women who tested positive for high-risk HPV, including several with normal cytology results.
Tempus AI’s xR RNA sequencing assay has received EU IVDR Class C certification, enabling continued clinical and biopharma access in the EU for gene fusion detection in solid tumors beyond the 2028 regulatory transition deadline.
A study of 60,449 lab results found that using broader screening thresholds doubled detection rates of primary aldosteronism compared to Endocrine Society guidelines, according to research in Hypertension.
The expanded partnership deploys the cloud-based HALO AP platform across enterprise laboratories to support emerging biomarker workflows and ADC pipeline diagnostics.
The new software aims to streamline genomic analysis, help researchers identify disease-related genetic variants, and support studies involving large datasets.
A global survey of 231 labs in 41 countries, published by IOF and IFCC, reveals significant inconsistencies in bone biomarker testing methods, reference intervals, and quality assessments, highlighting a need for greater harmonization.
The project will analyze immune cells from blood samples to help researchers understand how differences in the immune system influence disease risk, progression, and treatment response.
Variability in APTT assay results remains a challenge due to differences in reagents, activators, and detection systems, according to Sysmex, highlighting the need for lab-specific reference ranges and quality control protocols.
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.
IMS Solutions, a University of Birmingham and Imperial College London spin-out, has raised £1.1 million to commercialize mass spectrometry-based steroid biomarker tests for adrenal cancer and PMOS, with clinical validation underway.
UNC and Tulane researchers have developed a CRISPR-based microfluidic assay that identifies 15 nontuberculous mycobacteria species directly from clinical specimens in 3.5 hours, with over 97% sensitivity, according to a recent study.
Biodesix, in collaboration with Bio-Rad and Thermo Fisher Scientific, is advancing decentralized tumor-informed and tumor-naïve MRD assays designed for clinical labs, with validation underway at Memorial Sloan Kettering Cancer Center.
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.
A multicenter study from Johns Hopkins Medicine found that an FDA-cleared rapid urine assay detected 92% of invasive aspergillosis cases, offering results within hours and supporting faster, noninvasive diagnosis in clinical labs.