Anbio Biotechnology Ltd. launched the Anbio AF-100S, an automated, compact and affordable fluorescent immunoassay (FIA) solution that it hopes will transform the field of clinical diagnostics and empower healthcare providers. The AF-100S FIA is a handheld point-of-care immunodiagnostic solution that provides rapid, accurate and reliable results for a wide range of analytes.

With the spotlight at this week’s Alzheimer’s Association International conference firmly fixed on the first approved therapies, advances in diagnosing the neurodegenerative disease - on which effective use of new drugs will hang - attracted less attention. However, hand-in-hand with the development of anti-amyloid drugs, development of blood-based biomarkers has made significant progress and they now have the potential to form the basis of easy to access and low cost tests.

ArteraAI Inc. released data from a study it said validates the first-ever artificial intelligence (AI)-derived biomarker predicting the benefit of androgen deprivation therapy (ADT) for stripping prostate cancer of the testosterone it requires to grow.

Neko Health AB reported it has secured $67 million in investment capital to develop its artificial intelligence (AI)-driven full body scanner beyond its home country, Sweden. This series A round was led by Berlin-based Lakestar Advisors GmbH, with participation from Atomico (UK) Partners LLP from London and General Catalyst Group Management LLC from Cambridge, Mass. “Our new concept in body digitization technology, capable of rapidly collecting large amounts of health data, will enable us to identify illness at an early stage and take preventive action,” Hjalmar Nilsonne, CEO and co-founder of Neko Health told BioWorld.

T2 Biosystems Inc. received a third FDA breakthrough device designation with its direct-from-blood molecular diagnostic test for Candida auris. The test joins its T2resistance panel and T2Lyme panel in gaining the breakthrough recognition and the increased access to the FDA that comes with it as the company seeks final approval or clearance. The C. auris test enables identification of the challenging pathogen in three to five hours instead of the several days often required to grow a culture traditionally.

Researchers at Harvard Medical School have developed a new tool that promises to improve the way pathologists see and evaluate a tumor, by providing detailed clues about the cancer.

In a pivotal milestone for Memed Ltd., the U.S. FDA cleared its Memed BV test on whole blood samples, which will help health care providers distinguish between bacterial and viral infections. The test, which yields results in as little as 15 minutes, can reduce the risk of unnecessary prescriptions which is a key driver of antibiotic resistance.

Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.