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.

LONDON – Inivata Ltd. is extending efforts to bring its liquid biopsies into routine use, in two new clinical trials in lung cancer. The first will attempt to show increased speed in getting advanced non-small-cell lung cancer (NSCLC) patients on to the most appropriate therapies. The second study aims to demonstrate that detecting circulating tumor DNA (ctDNA) will single out those early-stage lung cancer patients who have residual or recurring disease after surgery and need further treatment with chemo- or immuno-therapies.

Oncology genomic testing company Berry Oncology Corp.’s latest research results showed promising data for its Hifi platform-based technology, its CEO Jun Zhou said during the first International Biopharma Industry Week held in Shanghai. With the Hifi liquid biopsy test, users can receive early screening of six cancers, including liver cancer, lung cancer, gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, with an overall sensitivity of 87.6%, specificity of 99.1%, and overall tissue of origin precision in 82% of positive cancers.

A pan-cancer liquid biopsy solution that was developed by Twist Bioscience Corp. and Anchordx Medical Co. Ltd. has been launched globally. The companies will market the Twist Alliance Pan-Cancer Methylation Panel (Pan-Cancer Panel) jointly. The Pan-Cancer Panel is a solution for pan-cancer study including DNA methylation library preparation and targeted enrichment for next-generation sequencing (NGS).

Savicell Diagnostics Ltd. has reported high accuracy results from a study validating its liquid biopsy platform Immunobiopsy. Haifa, Israel-based Savicell said the platform achieved high accuracy identifying lung cancer across stages I to IV. In a cohort of 245 participants, the Immunobiopsy test achieved 97% sensitivity and 97% specificity among patients with lung cancer.