Startup Aplife Biotech is tapping into the rapidly growing market for biosensors that can expand the capacity of hand-held devices to screen for thousands of pathologies from a single drop of blood. Using technology developed in Argentina to print DNA structures on microchips, the company’s goal is to screen as many as 20 million probes with the potential to convert molecular interactions into electrical signals, opening a path for med-tech developers and manufacturers to explore new solutions for personalized health care.
The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse.
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
For the next three years, the government of Shanghai will hand out R&D subsidies up to ¥100 million ($15.6 million) per year to each biopharma company in the municipality to support innovative medicines. Med-tech players can also each receive up to ¥15 million a year for developing innovative devices.
A new study by Laboratory Corp. of America Holdings (Labcorp) has found that nearly 9 in 10 COVID-19 patients continue to have antibodies to SARS-CoV-2 proteins 10 months after infection. Published in The Lancet-affiliated Eclinicalmedicine, the study provides real-world evidence of the persistence of SARS-CoV-2 antibodies in infected individuals, though the authors said more research is needed to determine if, and to what degree, protection against reinfection persists.
With the support of the NIH’s National Institute of Child Health and Human Development and the National Institute of Mental Health, researchers at Duke University’s Center for Autism and Brain Development have developed a mobile app that can quickly screen toddlers for autism spectrum disorder without the need for specialized skills.
HONG KONG – Genetron Holdings Ltd. is teaming up with JD Health International Inc. to develop full-cycle cancer management solutions encompassing both online and offline components. The partnership will focus on the six key areas of consumer health care, digitization of liver disease management, government medical associations, sharing of customer screening resources, industry, and user education as well as the consolidation of oncology doctors and experts on a single platform.
A check up by Khosla Ventures determined that Docbot Inc. was healthy enough for the prominent biotech investor to take the lead in a $4 million series A round. The new funds bring the artificial intelligence company to a total of $8.5 million in capital raised to date. Other participants included Bold Capital Partners, Collaborative Fund and Boutique Venture Partners.
PARIS – Biosynex SA signed a binding offer to acquire 100% of the stock in Avalun SAS, a company developing the Labpad in vitro diagnostic device that provides rapid biological test results from small sample volumes. In Europe, Avalun is currently marketing a follow-up test for patients on anticoagulation therapy using antivitamin K agents, and a test for automated antigen detection for COVID-19.
Veriskin Inc. has emerged from stealth mode with a noninvasive technology for skin cancer diagnosis and screening. The hand-held device, called Truscore, is designed to help nonexpert users quickly ascertain if a suspicious skin lesion is cancerous. Truscore works by detecting and interpreting force-induced hemodynamic differences between normal and malignant skin sores. It uses a proprietary artificial neural network-based artificial intelligence algorithm and protocols to differentiate skin cancers from other harmless skin conditions.