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.

Patent holders are wasting their resources when they ask the U.S. Court of Appeals for the Federal Circuit for an en banc rehearing on diagnostic claims that have been declared ineligible because they cite a law of nature.

LONDON – Monitoring low-density lipoprotein cholesterol (LDL-C) levels in patients with coronary heart disease (CHD) fails to identify those who are at the highest risk for heart attack or death, according to a new study that used alternative biomarkers to assess the risk of further events.

The ultimate vision is pretty fantastical: A variety of synthetically engineered bacteria working together to diagnose – and even secrete proteins to treat – various inflammatory conditions or other immune-associated diseases. But researchers at the Wyss Institute at Harvard University and Harvard Medical School have taken another step along the path toward that goal.