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CLIA

The firm said that its rapid flu detection platform helps reduce the subjectivity of interpreting test results and can be used in a broad range of healthcare settings.

The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.

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.

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