Under the agreement, Biodesix will use the Thermo Fisher Ion Torrent Oncomine Pan-Cancer Cell-Free Assay to generate data to apply for FDA premarket approval.
With two FDA-cleared platforms available, the technology is drawing clinicians interested in reaping its near-term benefits while preparing for its future impact.
The British team believes its classifier can identify men who will need treatment within five years, minimizing the need of repeated checkups for low-risk patients.
In issuing a proposed limited local coverage determination for Opko Health's 4Kscore, Novitas changed course from a previously issued non-coverage determination.
Authors concluded that all three assays — Oncotype DX, EndoPredict, and Prosigna — met Canadian thresholds for cost-effectiveness and urged caution in considering the findings.
Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
The study said that a revision of USPSTF's guidelines would lead to more equitable lung cancer screening for African American smokers at high risk for the disease.
The firm, which markets a clinical immunosequencing assay for leukemia and multiple myeloma, had originally expected to sell its shares at $15 to $17 apiece.
The firm expect to raise gross proceeds of $15 million, or $17.25 million if the offering's underwriter exercises its option to purchase additional shares.
The researchers said that their approach using 11 plasma protein biomarkers could enable early detection of ovarian cancers and reduce unneeded, associated surgeries.
