The company is developing a proprietary technology for the detection of RNA- and DNA-based genetic alterations in blood samples.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
The list of regulated analytes needs to be reviewed and updated so that external quality controls are in place to protect patients, proficiency testing providers said.
The company has developed a suite of tests designed to measure immunoglobulin E and immunoglobulin G levels for allergy and dietary wellness testing.
The test, which received FDA clearance in late 2017, runs in as little as 18 minutes.
The lab is located within Novogene's sequencing center at the Sacramento campus of the University of California, Davis.
According to the firm's CEO, there's a need for a portable hemoglobin measurement system that can deliver lab-quality results in the clinic within seconds.
Industry groups representing lab personnel strongly oppose CLIA's current practice of allowing personnel with nursing degrees to perform moderate- and high-complexity testing.
Lab industry groups hope to change CMS's controversial 2016 decision allowing nurses to perform complex lab tests.
The Xpert Xpress Flu can detect both influenza A and B virus in 20 minutes from either nasopharyngeal or nasal swabs.