New York State Department of Health
Under LDT Final Rule, Labs May Face Tough Choice Between FDA, New York Regulatory Paths for Tests
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The US Food and Drug Administration has established an enforcement discretion policy for LDTs approved in New York, setting up an alternative path to market.
Quadrant Laboratories Gets NYS Department of Health OK for Fragile X Syndrome Genetic Test
The company's saliva-based test, which is run out of its Syracuse, New York-based lab, is now available for physicians in all 50 states to order.
Pathnostics UTI Test Nabs New York State Approval
The molecular test identifies organisms and resistance genes combined with pooled antibiotic susceptibility results.
Castle Biosciences Gains New York State Approval for Pittsburgh Laboratory
The company can now serve NY state patients from either of its two facilities, in addition to populations across other US states under its existing CLIA certifications.
New York State Department of Health Approves Smart In Media Digital Pathology Solution
The whole-slide imaging-based method for digital slide scanning can be used with fine needle aspirates specimens.