The US Food and Drug Administration in May granted 510(k) clearances for tests and testing systems by Abbott, Hologic, and Becton Dickinson, among others.

A blood test identified patients with a treatable neurometabolic disease in a prospective trial, suggesting that it can be used to improve diagnosis of a condition that is currently detected using an invasive procedure.

Cue Health, a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.

According to Kalorama estimates, the Romanian IVD market, serving 18.8 million residents, grew to $464 million in 2022.

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that it has entered a strategic collaboration with Merck KGaA, Darmstadt, Germany to develop FoundationOne®Liquid CDx and FoundationOne®CDx as companion diagnostics in the U.S. market for selected marketed and pipeline treatments.

Global life sciences company Labcorp has introduced a new liquid biopsy test called Labcorp Plasma Focus.

Cepheid announced that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients with Acute Myeloid Leukemia (AML).

Agilent Technologies Inc. (NYSE: A) reported revenue of $1.72 billion for the second quarter ended April 30, 2023, an increase of 6.8% compared to the second quarter of 2022 and up 9.5% on a core(1) basis.

Welcome and thank you for being a part of the 20th China Association of Clinical Laboratory Practice Expo (CACLP) and the 3rd China IVD Supply Chain Expo (CISCE), which are set to kick off from 28-30 May 2023 at Nanchang Greenland International Expo Center.

Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B) and respiratory syncytial virus (RSV).

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

The major controlling party of Leadman, signed a cooperation agreement with GoBroad Health Group to build a research hospital project in Guangzhou Sino-Singapore Knowledge City.

Boulder, Colorado-based Transformative Biotech announced on Thursday that it has acquired extraction-free, direct-to-PCR technologies from Summit Biolabs for undisclosed terms.

OmicsEdge and Almaden Genomics said on Thursday that they have partnered on a service to analyze patient genomic data in clinical trials.

GenScript Biotech and Boan Biotech announced a collaboration for the development and production of GenCircleTM dsDNA, a small circular double-stranded DNA vector without resistance markers, a key ingredient in gene and cell therapy.