Trinity Biotech plc. received U.S. FDA 510(k) clearance for its lab-based hemoglobin diagnostic system, the Premier Resolution system, which the company hopes will allow it to regain its market leading position in hemoglobin variant detection. The Premier Resolution system is an automated analyzer which quantifies fetal hemoglobin and hemoglobin A2 and detects more than 200 hemoglobin variants. The device is a modern successor to the company’s Ultra system which once held a leading position in the U.S. hemoglobin variant diagnostic market.

Laboratory for Advanced Medicine & Health Group (LAMH)’s subsidiary Guangzhou Youze Biotechnology Co. Ltd. received marketing approval in China for its methylation test, which the company says is the first methylation test kit for liver cancer on the market in the world.

An estimated 10% to 20% of adolescents worldwide struggle with mental health issues. According to the CDC’s most recent Youth Risk Behavior Survey, nearly 60% of teen girls in the U.S. reported feeling sad every day for at least two weeks in the previous year and 22% of high school students considered taking their own lives. Yet despite these trends, the majority of mental health conditions in young people go undiagnosed and untreated.

Mirxes Holding Company Ltd. raised $50 million in a series D funding round to expand its cancer early detection blood tests, including its lead product stomach cancer blood test Gastroclear, in the Asia Pacific region. Mirxes uses RNA technology to develop diagnostic solutions for the early detection of diseases.

With more drugs for Alzheimer’s disease (AD) gaining FDA approval and an aging population at increased risk of dementia, the need for AD diagnostics is only going to grow. An estimated 6.7 million Americans live with Alzheimer’s today, with that number projected to hit 14 million by 2060, according to the CDC.

A new bacteriophage-based rapid test has the potential to identify the specific pathogen causing a urinary tract infection (UTI) at the point of care, enabling targeted use of antibiotics.

The test uses naturally occurring phages identified as predators of Escherichia coli, Klebsiella and Enterococci that are genetically modified to make any bacterium they invade bioluminescent.

In a proof-of-concept study, researchers at ETH Zurich, Switzerland, were able to reliably detect the pathogenic bacteria in a urine sample in less than four hours. That compares to the 18 – 30 hours it takes to culture samples in a central lab and to identify a specific microbe using conventional diagnostics.

Magentiq-Eye Ltd. received U.S. FDA 510(k) clearance for its Magentiq-Colo, an artificial intelligence (AI) gastrointestinal software system that helps detect lesions in real time during colonoscopy procedures. With the rate of colorectal cancer expected to increase steadily through the decade, the company hopes that Magentiq-Colo will offer the gastroenterology community and its patients a significant increase in the adenoma detection rate.

Fuzionaire Diagnostics Inc. has changed its name to Fuzionaire Theranostics Inc. to better reflect the company’s pipeline of paired fluorine-18 PET diagnostics and radioligand therapies to find and treat cancer.

Rapidai Inc. landed $75 million in a series C financing led by Vista Credit Partners. The funds will be used to fuel development of additional indications and expand market reach of its artificial intelligence (AI)-powered clinical decisionmaking and workflow support technology. With this latest round, the San Mateo, Calif.-based company has raised approximately $100 million, according to Crunchbase.

News from Truvian Health Inc. that its benchtop blood testing platform can deliver results similar to those generated by central laboratory is promising for the diagnostic sector still coming to terms with fraudulent claims from companies such as Theranos Inc. and Arrayit Corp. that their various technologies were able to run an array of tests with just a few drops of blood.