Burning Rock Biotech Ltd.’s share price flared up on Tuesday morning on news of U.S. FDA breakthrough device designation for its Overc multi-cancer detection blood test (MCDBT). The stock closed on Dec. 30, 2022, at $2.26 and rose sharply on the announcement to open at $2.89. By the end of the day, however, the stock had sunk to $2.15.

Some of the most exciting news out of the European Society for Medical Oncology Congress 2022 in Paris surrounded the rapidly evolving field of multi-cancer early detection (MCED), which offers the dual benefits of identifying malignancies at a more easily treated local stage and enabling screening for the 70% of cancers that lack recommended screening tests.

Pillar Biosciences LLC hopes to build a stronger foundation for its multi-cancer in vitro diagnostic, Oncoreveal Dx. The company filed a supplemental application for U.S. FDA premarket approval of eight additional types of cancer, which the agency accepted for review. The assay received FDA premarket approval for use in non-small cell lung cancer (NSCLC) and colon cancer in August 2021.

For a non-invasive cancer, ductal carcinoma in situ (DCIS) has spread rapidly—at least in research studies. Multiple companies presented results of diagnostic tests and genomic analysis that offer guidance for selecting treatment options for stage 0 breast cancer at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, which concluded in Chicago on June 7. Several of these studies reliably predicted which patients can safely be selected for active surveillance without surgery, who would benefit from endocrine or radiotherapy following surgery and who would be best served by risk-reducing surgery such as double mastectomy.

The American Society of Clinical Oncology (ASCO) updated its guidelines to recommend use of Biotheranostics Inc.’ Breast Cancer Index (BCI) molecular gene-expression test to aid decisions on extended endocrine therapy in certain patients with the most common type of breast cancer.

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.

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.

The U.S. Preventive Services Task Force (USPSTF) appears on the verge of expanding colorectal cancer screening to individuals ages 45 to 49, based on its latest draft recommendations. If it does, Exact Sciences Corp. is ready. A study in Cancer Prevention Research demonstrated that the Madison, Wis.-based company's Cologuard multitarget stool DNA test had better than 95% specificity in individuals with nonadvanced precancerous lesions or negative findings on colonoscopy.

Shares of early cancer detection company Exact Sciences Corp. soared Tuesday morning on news it is acquiring two liquid biopsy screening companies, Thrive Earlier Detection Corp. and Base Genomics Ltd., for $2.56 billion and selling $869 million of common stock to institutional investors.