The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
The European Commission will review CHMP's opinion based on the Keynote-177 data and is expected to issue a final decision in the first quarter of 2021.
The partners are starting by testing patients with colorectal and thyroid cancers using the 648-gene Tempus xT assay, but could expand to other areas in the future.
The test, called Immunoscore, is designed to predict the risk of relapse in early-stage colon cancer by measuring host immune responses at tumor sites.
The company hopes the data will help convince clinicians to adopt the algorithm in CRC as it pushes forward validations for other areas like pancreatic and ovarian tumors.
Persephone Biosciences has launched a prospective, longitudinal study to evaluate 4,000 patients' gut microbiomes and link them with cancer treatment response.
The firm will collect stool and blood samples from 4,000 cancer patients and determine whether their microbiome composition affects their response to therapy.
