The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.
The company will now be able to market the test, which algorithmically weighs molecular markers and clinical information, in all 50 US states.
The test is based on RNA sequencing and is used to differentiate between idiopathic pulmonary fibrosis and other lung diseases in order to avoid surgery.
The addition of the Y chromosome detection will enable the firm to refine its already-approved MaternalFetalScreen T1 test to provide personalized risk assessment.
The PhosphorusOne test uses next-generation sequencing to analyze 375 genes covering 170 inherited conditions and 175 different drug reactions.
The tests are designed to detect genetic variations including SNPs, insertion-deletions, copy number variations, and variations in segmental duplications.
The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.
The test is the first whole-genome-based cancer test to receive approval from New York State's Department of Health.
With the approval, MDxHealth can now offer its liquid biopsy molecular diagnostic assay in all 50 US states.
NYSDOH's move away from susceptibility testing for isolates that are known to be pan-susceptible will be coordinated with similar international efforts.