The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in 2016, the test requires patients to sit in front of an all-in-one tablet-looking device and follow a series of moving targets. The goal is to identify ocular tremors, a persistent issue with Parkinson’s patients that prevents steady fixation on objects and images. The noninvasive test, which measures an individual’s ability to follow objects on a screen, could help doctors not only confirm the difficult-to-diagnose disease, but also detect it at earlier stages.

The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.

HONG KONG – Neurophet Inc., a South Korean AI-based brain disease diagnostics company, has secured ₩6 billion (US$5.1 million) in series A funding. The med-tech startup produces solutions based on Segengine, the company’s own technology that automatically segments brain magnetic resonance (MR) images into 107 regions within a minute.

Huntington’s disease is a fatal hereditary disease that results in the progressive breakdown of nerve cells in the brain. It erodes a person’s physical and mental abilities, usually beginning in their 30s and 40s, and to date has no cure. Now Austin-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to develop companion diagnostics (CDx) for Wave’s investigative allele-selective therapeutic programs targeting the genetic cause of the disease.

LONDON – Mologic Ltd. has started recruitment in a 263-patient trial to validate its urine-based home test for anticipating exacerbations of chronic pulmonary obstructive disease (COPD). The lateral flow immunoassay self-test detects five biomarkers of the lung disease in urine that are indicative of inflammation and infection.

Urinary tract infections (UTIs) are a common reason for women to visit their doctor. While virtual doctor visits have been possible to detect UTIs, patient-reported symptoms typically have drove diagnoses. Now, Los Angeles-based Scanwell Health is bringing its at-home smartphone-enabled test and treatment service for UTIs to all 50 states. Scanwell said its offering its the first U.S. FDA-cleared urine testing app available over-the-counter without a prescription.