As regulatory changes and technical advances reshape the clinical lab, directors are seeing a shift in responsibilities and the expertise required for the job.
The firm said it needs more time to ensure that the DetermaVu assay is providing the most consistent and sensitive results for patients.
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.