Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology.
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.
HONG KONG – Lucence Diagnostics Pte Ltd., a genomic medicine company headquartered in Singapore, has secured $20 million in series A investment. The company is focused on inventing liquid biopsy tests for cancer screening and personalizing care.
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make that tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.
PERTH, Australia – Telix Pharmaceuticals Ltd. raised AU$40 million as it prepares regulatory packages and commercial strategies in Europe, the U.S. and Australia.
Liquid biopsy startup Freenome Inc., of South San Francisco, reeled in $160 million in a series B financing that was led by RA Capital Management and Polaris Partners. The funds are earmarked to advance Freenome's multiomics blood testing platform for early cancer detection and to grow its laboratory and software capabilities.
LONDON – Monitoring low-density lipoprotein cholesterol (LDL-C) levels in patients with coronary heart disease (CHD) fails to identify those who are at highest risk for heart attack or death, according to a new study that used alternative biomarkers to assess the risk of further events.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
LONDON – Cytox Ltd. is launching a genetic test that can predict the risk of developing Alzheimer's disease and is able to single out which people presenting with symptoms of mild cognitive decline will go on to most rapidly develop Alzheimer's disease.
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