The U.S. FDA’s effort to regulate lab-developed tests was predictably controversial, but the final rule drew a second lawsuit, this time from the Association for Molecular Pathology.

Skin biopsies could be a thing of the past thanks to the development of a new non-invasive microneedle patch to pre-screen for skin cancer. Dermr Health Solutions Pty Ltd. founder and CEO Stefan Mazy told BioWorld that the fledgling genomics startup company is pushing the boundaries of science with its Dermr patch that quickly and painlessly extracts live skin cells in 15 seconds, drastically cutting the time and discomfort associated with traditional biopsy procedures.

The first patenting from Hemeo BV describes its development of Vantage, an artificial intelligence powered clinical decision support software for coagulation management.

Molecular Health GmbH believes that the integration of all the different types of data currently used to aid in the analysis of health conditions will be essential to the future of diagnostics.

The U.S. National Institutes of Health sponsored a study that was designed to establish whether there are any biomarkers that are strongly associated with the constellation of symptoms known as long COVID, but the study shed little light on the question.

The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.

An artificial intelligence algorithm developed at Sheba Medical Center in Israel can identify patients at high risk of pulmonary embolism as soon as they walk through the hospital doors, a study published in the Journal of Medical Internet Research found. Using only information available from the patient’s medical history, the machine learning tool flagged high-risk patients before the initial clinical checkup occurred.

The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP) urged the agency to reconsider the COVID-19 experience.

Seoul, South Korea-based Adel Inc. raised ₩17 billion (US$12.39 million) in bridge financing to advance its pipeline of Alzheimer’s disease therapies, including its tau antibody-based ADEL-Y01 candidate, currently in a U.S.-based phase I study.

In what represents just the second PCT filing to have emerged from Valar Labs Inc., the company’s co-founders – Joshi Anirudh, Viswesh Krishna, and Damir Vrabac – describe their development of an AI-derived histologic signature for predicting patient outcomes to treatments for pancreatic cancer.