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.
Nasdaq told the company that its shares have failed to meet a minimum $1 per share closing price for 30 consecutive days and may face delisting action.
Using a fingerstick, the Mylan HIV Self Test can be completed at home and detects whether HIV antibodies are present in about 15 minutes.
The Elisabeth Severance Prentiss Foundation gift will expand research into the use of saliva to monitor lithium levels in patients with bipolar and other disorders.
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.
The project, called Seq&Treat, will be implemented in Brazil, China, Georgia, India, and South Africa starting in October.
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 firm is validating a mild TBI biomarker-based diagnostic kit for use by paramedics, first responders, and other healthcare professionals.
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.
Rapid Biosensor Systems said its point-of-care pre-production breath system has achieved high performance during TB field testing in Ethiopia and India.
The test uses unique PCR chemistries as well as a streamlined sample prep method to detect resistance mutations without DNA extraction.
The funding will be used to support clinical validation and expand market access for the firm's endometriosis diagnostic test.
The antibody, called leronlimab, is a CCR5 antagonist under development by CytoDyn for a variety of indications including HIV and breast cancer.
The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
The firm's CEO said it is continuing to develop its distributor network to make its tests available in centralized and decentralized settings globally.
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.