Six minutes of walking data collected by a smartphone sensor could provide population level health screening, researchers reported in PLOS Digital Health. The study tracked more than 100,000 people as they went about their day wearing activity monitors similar to motion sensors used in smartphones. The sensors captured information on intensity from short burst of walking to predict five-year mortality risk, independent of age and sex.
Oncores Medical Pty Ltd. reported positive data from its first in-cavity trial of its quantitative micro-elastography (QME) imaging system, a hand-held imaging tool that helps surgeons differentiate between cancerous and healthy breast tissue at the point of surgery.
Just as the U.S. FDA gathered industry leaders to address the issues posed by pulse oximeters that provide inaccurate measurements for individuals with darker skin, Biointellisense Inc. released its own FDA-cleared technology that provides accurate readings regardless of skin tone. The challenge of inaccurate readings for people with darker skin came to the fore with the COVID-19 pandemic as fingertip pulse oximeters emerged as a convenient method of monitoring for hypoxia at home and in clinics, but frequently overreported oxygen levels in the blood of people of color, leading to delayed treatment.
A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.
The U.S. FDA’s interest in regulating lab-developed tests (LDTs) occasionally prompts the agency to engage in a little saber-rattling about rulemaking if Congress should fail to pass legislation granting the FDA explicit authority to regulate these tests.
Jiangsu Cowin Biotech Co. Ltd. has raised ¥1.14 billion (US$156 million) in a listing on the Shanghai STAR Market. Its shares opened at ¥42.96 apiece, plunged over 13% by the middle of the day but closed at ¥43.62 on the first trading day on Oct. 25.
Deepull Diagnostics SL has raised €13 million (US$12.71 million) in a series B round to advance development of a PCR-based rapid diagnostic for the early diagnosis of sepsis and acute infections.
HKSH Medical Group (HKSH) has adopted droplet digital polymerase chain reaction (ddPCR) for minimal residual disease (MRD) monitoring to track the status of patients with leukemia.
Aural Analytics Inc. and Hhitt Inc., dba Hitcheck, teamed up to offer a cognitive assessment application that could quickly answer the question, “Should he play?” after a hit to the head during a game. Considering the controversy over Miami Dolphins quarterback Tua Tagovailoa’s loss of consciousness following his second head injury in two games last month, the cognitive assessment tool, which includes clinical-grade speech analytics, comes none too soon.
Pharus Diagnostics Inc. emerged from stealth mode to streamline precision medicine-based cancer screening with its new multi-cancer early detection liquid biopsy test. Spun out from Hsinchu, Taiwan-based Quark Biosciences Taiwan Inc. in July 2022, Pharus is developing solutions to detect cancer early via Oncosweep, its multi-cancer early detection (MCED) liquid biopsy test that evaluates microRNA (miRNA) within the body.