The U.S. FDA has granted Datar Cancer Genetics Ltd. a breakthrough device designation for a blood test to detect early-stage prostate cancer. The circulating tumor cell (CTC) detection blood test can identify early-stage prostate cancer in men of age 55-69 years at around 99% accuracy.

Inivata Ltd. published new data from a prospective clinical study assessing its Radar diagnostic test in head and neck squamous cell carcinoma (HNSCC). Results from the Liquid Biopsy for Minimal Disease Detection in HNSCC (LIONESS) study suggest the assay demonstrated 100% specificity in patients with no recurrence and 100% sensitivity in patients with clinical recurrence. The personalized assay can track up to 48 tumor-specific variants in a patient using a blood sample. Last year the test was granted breakthrough device designation by the FDA.

Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.”

PARIS – Damae Medical SAS has just raised nearly $6 million to develop new technology to detect skin cancer noninvasively without need for a biopsy. This series A round was led by BNP Paribas Développement SA and supported by original investors Kurma Partners SA and professional private equity fund, Paris Saclay Seed Fund.

As attention turns to new drugs that can address the growing burden of Alzheimer’s disease (AD) in an aging global population, Retispec Inc. has developed a noninvasive test that may be able to detect early signs of the neurodegenerative disease decades before clinical symptoms appear – and when therapies appear to be most helpful in slowing or reversing Alzheimer’s. By using “off-the-shelf” ophthalmic equipment, the Toronto-based company’s solution enables assessment by optometrists or other eye professionals during a standard eye exam.

PARIS – Resilience SAS raised $46 million in a series A round to ramp up European distribution of its mobile application intended for remote monitoring of breast cancer patients, in partnership with the Gustave Roussy Center in Villejuif, France. This funding round was led by two Parisian venture capital funds specializing in digital health – Cathay Innovation SAS and Singular Capital Partners SAS – along with Dutch-based Exor Seeds NV, German-based Picus Capital GmbH and Seaya Capital Gestion, SGEIC, SA, from Spain.

The Royal Academy of Engineering in the U.K. has revealed a new batch of 70 entrepreneurs, including some developers of med-tech solutions, for its Leaders in Innovation Fellowships Global (LIF Global) program. This comes just two months after the LIF Advance edition of the initiative, which had 15 chosen. The selected entrepreneurs will receive equity-free support over the next six months from the training and mentorship program.

Scientists from Healthbiocare GmbH, System Biologie AG and the University of Austria have published data indicating pan-cancer detection could be achieved by combining genetic and epigenetic biomarkers in plasma. The scientists developed a classification model that distinguished between healthy subjects and patients with solid tumors with 95.4% accuracy, 97.9% sensitivity, and 80% specificity.