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.
The tests can detect several species of Borrelia burgdorferi, the tick-borne parasite primarily responsible for all Lyme disease cases in the US.
Despite the astronomical costs, it may prove challenging to reverse course and discontinue Zika testing according to a commentary article accompanying a NEJM study.
The approvals allow the company to offer its PCR-based expression profile cancer risk tests in the state.