The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
HONG KONG – The third pre-revenue med-tech firm to list on the Hong Kong Stock Exchange in a month, New Horizon Health Technology Co. Ltd. raised HK$1.9 billion (US$245.08 million) in an IPO that began trading Thursday, Feb. 18. New Horizon placed 76.6 million shares at HK$26.66 apiece and said part of the funds will help the company commercialize its FIT-DNA test Coloclear to screen for colorectal cancer.
Braincool AB has scored a breakthrough device designation from the U.S. FDA for its Cooral system, a medical cooling technology for therapeutic hypothermia and oncology. The status acknowledges Cooral’s potential to prevent oral mucositis (OM), a complication of chemotherapy.
Personal Genome Diagnostics Inc. (PGDx) secured $103 million in a series C fundraising round led by Cowen Healthcare Investments and other stars of the med-tech investment world. Participants included Northpond Ventures, Vensana Capital, Rock Springs Capital, Kern Capital, Sands Capital, PFM Health Sciences, Windham Ventures, New Enterprise Associates, Innovatus Capital Partners, Catalio Capital Management, and others.
KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined. And after 40 years, they look to be getting a targeted therapy, or even two.
Hologic Inc. is teaming up with Google Cloud to use machine learning technologies to improve the accuracy and timeliness of cytology for cervical cancer screening. Marlborough, Mass.-based Hologic, which makes both Pap and human papillomavirus (HPV) assays, is already using artificial intelligence (AI) and machine learning in its new digital cytology platform that is available in Europe. The multiyear collaboration with Mountain View, Calif.-based Google Cloud will start with innovating that product further by enhancing the deep learning component of the system.
Mckesson Corp. has brought together several oncology organizations, life sciences companies, and patient advocacy groups to increase understanding of non-small-cell lung cancer (NSCLC) and leverage targeted therapies to improve outcomes. The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG) study will observe and analyze 12,000 community-based, metastatic NSCLC patients to learn more about barriers to molecular testing for targeted therapies, how those therapies are being used, and to expand opportunities for participation in clinical trials.
PERTH, Australia – Wellington, New Zealand-headquartered Volpara Health Technologies Ltd. has acquired Boston-based CRA Health LLC for $18 million up front and an additional $4 million to be paid over the next 18 months in earnouts. Volpara’s digital health solutions use imaging and artificial intelligence (AI) for early detection of breast cancer. The company’s clinical functions for screening clinics provide feedback on breast density, compression, dose, and quality, while its enterprise-wide practice software management helps with productivity, compliance, reimbursement and patient tracking.
In a task made more challenging by COVID-19, the EU and the World Health Organization are rolling out separate plans to take down cancer in Europe. The European Commission Feb. 3 announced its Europe’s Beating Cancer Plan, the first comprehensive European cancer initiative in nearly 30 years. A day later, WHO/Europe launched its United Action Against Cancer, billing it as a “pan-European cancer movement” to galvanize support and cooperation from grassroots to governments with the long-term goal of eliminating cancer as a life-threatening disease in the region.
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.