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.
The partners are working together to advance tests that will identify which cancer patients have Notch activating mutations and fusions.
The deal, which is initially for five years, also covers the Eurasian Customs Union, with an option for other countries in the area.
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.
The antibody, called leronlimab, is a CCR5 antagonist under development by CytoDyn for a variety of indications including HIV and breast cancer.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
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.
The test measures levels of seven auto-antibodies to tumor-associated antigens, and is designed to detect all forms of lung cancer at any stage.
The agreement consists of a $100 million revolving credit facility, a $100 million initial term loan, and a $50 million delayed-draw term loan.
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.
Guardant told a federal judge that it believes Foundation Medicine and Personal Genome Diagnostics are coordinating to invalidate its patents.
The firm said it needs more time to ensure that the DetermaVu assay is providing the most consistent and sensitive results for patients.
AnchorDx, based in Guangzhou in southern China, will use Illumina's MiSeqDx sequencer to develop IVD cancer test kits and data analysis software.
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 deal covers the PlexBio IntelliPlex diagnostic instrument platform and reagent kits for oncology and infectious disease testing.
The researchers said that their approach using 11 plasma protein biomarkers could enable early detection of ovarian cancers and reduce unneeded, associated surgeries.