In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.
An Australian research group is developing a diagnostic test that uses an engineered toxin to detect an abnormal sugar in the blood of ovarian cancer patients.
The FDA granted the assay's status based on its ability to detect both ovarian and pancreatic cancer in asymptomatic individuals over the age of 65.
Years after several high-profile failures, activity is up among researchers looking to multi-analyte protein assays for monitoring and detection of the disease.
The investment bank cited disappointing first quarter financial results, a slow uptake to the business, and competitive pressures for the downgrade.
The firm is using $350,000 in recently awarded NIH funds for a clinical study of its glycan test for predicting response to chemotherapy in ovarian cancer.
Currently available screening methods have not been shown to reduce mortality in the general population, USPSTF said.
The Seoul-based company also recently raised $1.9 million in series B funding and is targeting between $7 million and $8 million to close the round.
NGeneBio said this week that its next-generation sequencing panel has been approved as an IVD, the first NGS test to be cleared in Korea.
The drugmaker will use Myriad's expanded molecular diagnostic panel to evaluate best responders to a combination of Lynparza and Avastin in clinical trials.