The company's approach involves using both fluorescence in situ hybridization and next-generation sequencing to provide clinicians with information.
Formerly called OncoCell MDx, the Royal Oak, Michigan-based firm aims to complete a validation study for the prostate cancer risk assay within the next two months.
The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.
Researchers in the US and the United Arab Emirates found that RNA-seq in B-lymphoblastoid cell lines can help identify pathogenic variants that DNA testing missed.
The LCD for the RNA gene expression test will take effect on Feb. 10, 2020, the Medicare contractor said.
While NanoString will commercialize its nCounter for research use applications, Veracyte will move its current assays onto the platform to reach a global audience.
Veracyte has also acquired Nanostring's Prosigna breast cancer and LymphMark lymphoma assays and plans to develop diagnostic tests using the nCounter platform.
The number of technologies to be assessed is vast, and ranges from liquid biopsies and molecular imaging to immunohistochemistry and RNA-seq.
The assay, being developed in partnership with Johnson & Johnson, will complement computed tomography imaging by combining 26 genes and clinical variables for lung cancer detection.
For the three months ended Sept. 30, the firm reported total revenues of $31.0 million, beating analysts' average estimate of $30.1 million.