The test showed 90 percent sensitivity and 75 percent specificity in a 250-patient blinded study, even without the addition of clinical risk information.
CMS says fee hike would bring in $62.1 million, an amount necessary to maintain critical regulatory functions of the CLIA program into fiscal year 2022.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
The lab will test samples reimbursed only by the federal government. Attis expects it will test a baseline of 3,000 toxicology samples per month by the end of 2018.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
