The firm is moving into a larger facility after its first full year of profitability and planning new hires to support its plans to bring liquid biopsy kits through the FDA.
The collaboration aims to eliminate barriers to testing for chronic kidney disease by standardizing the method for testing for the condition, thereby improving the comparison of test results between labs.
Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.
The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.
The agency said that its action on MSK IMPACT "advances a policy framework that paves the way for the efficient review and availability of other NGS-based cancer profiling tools."
Pathoquest will compare its iDtect blood test with standard testing methods to identify microbes causing infections in patients with febrile neutropenia.
More than a third of the first 10,000 patients receiving MSK-IMPACT harbored actionable mutations, and 11 percent of the first 5,000 enrolled in a clinical trial.
