C2i Genomics Inc. reported the formal launch of its C2inform minimal residual disease diagnostic across Europe, after obtaining CE marking for the cancer test. The Cambridge, Mass.-based company also has completed several clinical trials it ran with research partners to validate the technology and will be presenting data in different cancers at the American Association for Cancer Research in New Orleans, April 8-13.

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.

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.

University of Edinburgh spinoff Biocaptiva Ltd. is taking its cell free DNA (cfDNA) capture device to clinical trials in 2022 following promising preclinical results. The company’s platform technology is designed to increase the quantity of cfDNA available for liquid biopsy testing. Current liquid biopsy practices obtain cfDNA via a venous blood draw but the concentration of tumor-derived ctDNA can be too low for comprehensive testing. Biocaptiva’ device emerged from research at the University of Edinburgh investigating liquid biopsy technologies.

With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.

In a lively discussion at the 40th annual J.P. Morgan Healthcare Conference, panelists from leading diagnostics companies debated the best way to screen for cancer – and whether diagnostic testing does more harm than good in some circumstances. Kevin Conroy, CEO of Exact Sciences Corp., noted that he expected liquid biopsies to have an “enormous impact on making earlier cancer detection a routine part of medical care” with his company currently developing a blood-based test for colon cancer as well as a multicancer test and one for minimal residual disease.

Quidel Corp. reported a definitive agreement to acquire Ortho Clinical Diagnostics Holdings plc in a nearly $6 billion deal expected to close in the first half of 2022. The $24.68 per share offered by Quidel represents a nearly 25% premium over Ortho’s closing price as of Dec. 22. Quidel will also assume $2 billion in debt. In addition, Laboratory Corp. of America Holdings (Labcorp) said it would acquire Baltimore-based Personal Genome Diagnostics Inc., which offers a portfolio of genomics-based liquid biopsy and tissue-based diagnostic products, for $450 million in cash at closing plus up to $125 million contingent on achieving specific performance milestones. That deal is also expected to close in the first half of 2022, pending approval by both companies’ shareholders.

Astrazeneca plc has signed an agreement with liquid biopsy testing company Saga Diagnostics AB to develop dPCR assays. Lund, Sweden-based Saga Diagnostics will develop Sagasafe dPCR assays towards undisclosed methylated targets for analysis of tissue samples and liquid biopsies. The assay is part of Saga’s portfolio of “ultrasensitive technologies,” comprising Sagasign for personalized monitoring of cancer burden and minimal residual disease.

Diacarta Inc.’s diagnostic assay, Coloscape, could be the first to meet the Centers for Medicare and Medicaid Service (CMS)’s strict standards for Medicare coverage of a liquid biopsy for colorectal cancer screening if results seen in a Plos One study are borne out in larger trials and the test gets the nod from the FDA. That is a lot of ifs, but the study posted strong results: 100% specificity and 92.2% sensitivity for cancer and 95% specificity and 62.5% sensitivity for precancerous lesions.