DiaSorin said Tuesday that it has secured CE marking for an immunodiagnostic assay to aid diagnosis of severe conditions including sepsis, septic shock, kidney diseases, and lower respiratory and urinary tract infections, and the firm is launching the assay in Europe.

Roche announced that the cobas® HPV test for use on the cobas® 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions.

Looking at the overall environment, the receding of the COVID-19 testing dividend, the slowdown of conventional business growth, and the pressure from the collection policy have all brought the IVD industry into an adjustment period.

HumaDX Tech Co., Ltd. (abbreviated as "HumaDX") completed its A2 round of financing in the first quarter of this year, with this round jointly invested by Wenrun Investment and Sunland Fund.

Results from the 100,000 Genomes cohort in the U.K. show that RNA sequencing has the potential to increase the number of diagnoses given to individuals with rare disease.

Asep Medical has entered a definitive agreement with Seaspring for sepsis diagnosis technology Sepset.

MGI Tech Co., Ltd. (referred to as MGI) announced that it has entered into a comprehensive cooperation with AddLife AB, one of Europe's largest clinical testing and laboratory equipment channel providers based in Stockholm, Sweden, to accelerate the expansion of MGI's sequencing instrument and laboratory automation equipment in the Nordic region.

T2 Biosystems said on Friday that it is collaborating with Vanderbilt University Medical Center to implement and evaluate the firm's T2Bacteria Panel in clinical settings.

In the decade since Foundation Medicine first launched its FoundationOne genomic profiling test to look for specific biomarkers in tumor tissue samples, it has racked up dozens of FDA approvals allowing the test to serve as a companion diagnostic for a broad spectrum of cancer drugs.

South Korean liquid biopsy firm IMBdx said Thursday that it is expanding an ongoing collaboration with AstraZeneca under a project called PROSPER 2.0, which aims to improve access to targeted therapies for individuals with metastatic prostate cancer in markets outside the US.

Life sciences proteomics firm Seer on Wednesday announced an expanded collaboration with Thermo Fisher Scientific.

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that our flagship comprehensive genomic profiling (CGP) product, OncoScreenTM Plus, was featured in a phase 3 multi-regional clinical trial (MRCT), along with FoundationOneCDx, in support of advancement in breast cancer treatment.

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.