With an at least $60 billion total addressable market, the liquid biopsy sector offers abundant opportunity for multiple companies to swim to the top. The six largest companies in the pool have just dipped their toes in the water, with a total penetration of only 10%, a white paper from RBC indicates.

Samsung Life Science Fund made its first strategic investment of the year into C2N Diagnostics LLC, underscoring the rising potential of blood-based diagnostics in detecting and monitoring the risk of Alzheimer’s disease for the masses.

Grail Inc.’s multi-cancer early detection test, Galleri, preferentially screens for aggressive prostate cancer, addressing concerns about overdiagnosis and subsequent overtreatment of indolent cancers, a study published in JCO Precision Oncology demonstrated.

The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.

Novigenix SA reported interim European validation data for its whole blood RNA signature for early detection of precancerous colorectal lesions. The data was presented in early July at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona.

Even without an oracle, it is clear that Delfi Diagnostics Inc.’s $225 million series B fundraising round positions the company well to further develop its liquid biopsy tests for early cancer detection and monitoring. Delfi’s liquid biopsy platform uses a whole genome fragmentation analysis approach for both individual cancer and multicancer detection.

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.