The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
Research presented at ACMG by Invitae suggests that clinically actionable variants in cancer patients are missed by germline testing that is not done with expanded panels.
As of January the project had returned 290 positive results for CDC Tier 1 conditions from 23,500 participants who had undergone exome sequencing.
Clinical researchers at AACR discussed a wide range of approaches focusing on several different potential use-cases in the detection or assessment of early cancers.
VolitionRx's platform uses the company's Nucleosomics technology for identifying and quantifying nucleosome structural features such as histone modifications.
The company's assay relies on a set of 15 methylation and microRNA markers to determine whether a woman has breast cancer.
The device, called the MasSpec Pen, was developed by University of Texas researchers to help more quickly and accurately assess margins during cancer surgery.
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.