CLIA

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.

Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.

The fluorescent immunoassay was cleared to run on the next-generation Sofia 2 platform and runs using a finger-stick whole-blood specimen.

CLIP program requirements are comparable to requirements for CLIA accreditation but might be modified to meet Department of Defense mission needs.

The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.

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.

The company is developing a proprietary technology for the detection of RNA- and DNA-based genetic alterations in blood samples.

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