LONDON – Liquid biopsy specialist Inivata Ltd. has been granted a U.S. FDA breakthrough device designation for its Radar assay for detecting residual disease or relapse, following treatment for cancer. The personalized assay, which tracks a set of up to 48 genetic variants isolated from excised tumor tissue, is built on Inivata’s approved Invision platform for detecting circulating tumor DNA (ctDNA) in blood samples.

PARIS – Median Technologies SA has unveiled a new clinical development plan for its Ibiopsy platform to provide early diagnosis of lung cancer in at-risk populations using low dose CT scans. Median executives said they hope to demonstrate the potential of deep learning in identifying lung lesions and characterizing them as malignant or benign.

Histosonics Inc. is testing its investigational histotripsy technology to destroy liver tumors in two clinical trials in the U.S. and Europe, with the goal of seeking regulatory clearance for the platform in 2022. The technology uses the science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted primary and metastatic liver tumors from outside the body.

Agilent Technologies Inc. will acquire Resolution Bioscience Inc. for $550 million in cash at closing and up to an additional $145 million based on performance milestones. The deal will expand Agilent’s cancer diagnostics offerings and its presence in next-generation sequencing (NGS) technology for the fast-growing precision medicine market. The acquisition is expected to close in April 2021.

PERTH, Australia – The fight against diffuse intrinsic pontine glioma may finally see some progress, after experiments using 3D models of the tumor in animal studies showed that a combination therapy of the polyamine inhibitor AMXT-1501 (Aminex Therapeutics Inc.) and the ornithine decarboxylase 1 inhibitor difluoromethylornithine could eradicate cancer cells.

Grail Inc. is teaming up with Quest Diagnostics Inc. to support the upcoming launch of its multicancer blood test. The early cancer detection test, called Galleri, is slated to begin rolling out in the second quarter of 2021. Quest’s 2,200 patient service centers and network of 5,000 mobile phlebotomists will help to collect blood samples for Galleri once the test becomes available in the U.S.

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.