Molika Ashford covers personalized medicine and molecular diagnostics for GenomeWeb.
New companies claimed stakes during the year, established firms solidified their plans and data, and Grail launched the first genomic multi-cancer early detection test.
The company had previously planned to develop IVD kits for the US market but is now aiming to launch a lab-developed test in the second half of 2022.
The company failed in its first bid for breakthrough device designation but has now split out new specific indications for which it is building more persuasive utility data.
The company believes its fixed-panel, informatically guided approach can help capture the most possible patients with signs of residual or recurring cancer.
New data from a Japanese Phase II study have solidified a path forward for pertuzumab plus trastuzumab in HER2-positive colorectal cancer patients.
As economic and practical challenges of next-gen sequencing have eased in recent years, more groups are bringing comprehensive cancer genomic testing in house.
The company said it expects to launch an in-licensed lung cancer treatment decision assay next year, alongside its own multi-cancer early detection and MRD products.
The company will compete against established comprehensive genomic sequencing assays, but hopes to provide better immunotherapy prediction.
The company is validating early promising data for an exosomal-protein based signature to identify asymptomatic individuals with early pancreatic cancer.
The company has slightly extended its timeline for launching a Lyme disease test to focus on marketing its COVID assay for immunocompromised individuals.