Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
Investors showed some love to French remote patient monitoring and cardiac data startup Implicity SAS, contributing $23 million to the company’s series A financing round. New investors Crédit Mutuel Innovation and Bpifrance led the round with support from BNP Paribas Development and returning seed investors Serena, Xange and Karista.
China’s Amoy Diagnostics Co. Ltd. (Amoydx) signed a development and commercialization agreement under which Amoy will develop multiple companion diagnostics for Astrazeneca plc across China, the E.U. and Japan.
A research team from the Grenoble Institute for Neuroscience (GIN) recently discovered a blood biomarker capable of detecting the onset of Parkinson's disease (PD) from a very early stage. This discovery represents the findings of a multi-model, translational study published in the Journal of Clinical Investigation.
Health tech firm Qure.ai Technologies Private Ltd. has secured a $40 million investment from investors including Novo Holdings and Healthquad to expand its portfolio of automated artificial intelligence (AI)-based imaging diagnostics. The company’s suite of technologies incorporates deep learning and AI to interpret radiology images such as X-rays, CTs, and ultrasounds in less than a minute.
Vivosense Inc. aims to improve clinical trial recruitment and outcomes by developing new digital biomarkers and clinical outcome assessments (COAs) that use data from wearable devices, a goal made a touch easier by its successful completion of a $25 million series A financing round. The company’s platform is designed to detect and rigorously interpret subtle shifts in physiology using body-worn sensors.
Neogenomics Inc. stunned investors, reporting that Mark Mallon would step down as CEO and board member, effectively immediately. Tuesday’s unexpected announcement – coupled with news that first-quarter revenue could miss prior guidance – sent Neogenomics stock (Nasdaq: NEO) down 29.8% to close at $12.49, and triggered a 52-week low of $11.00 earlier in the day.
Cancer Research UK took a significant hit when its U.K.-wide charity shop chain had to close last year because of the pandemic. But, according to latest figures, its commercial arm could help it to bounce back after seeing its income more than double in the recent biotech boom. The organization reported record levels of investment in its spinout companies, which more than doubled in 2020-2021 compared with the previous year, jumping from £400 million (US$555 million) to £822 million (US$1.14 billion)
Two players in the gene sequencing space, Illumina Inc. and Pacific Biosciences, have scotched their planned $1.2 billion merger roughly two weeks after the U.S. Federal Trade Commission posted a 5-0 vote to seek an injunction against the merger.
HONG KONG – Fujifilm Corp. has entered an agreement with Hitachi Ltd. to acquire Hitachi Ltd.’s diagnostic imaging-related business to further expand Fujifilm’s health care business. Prior to the acquisition, Hitachi will found a new company and implement an absorption-type company split whereby the new company will absorb the business.
