With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
The company's Acucy Influenza A&B test detects viral nucleoprotein antigens from nasal and nasopharyngeal swabs.
The lab can now receive US specimens for testing with its LiquidHallmark blood test that detects cancer-causing gene mutations and viruses.
The biotech company focuses on early cancer screening and detection and sells a multi-cancer screening and detection test in China.
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.