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Currently under development by a number of IVD firms, these protein tests offer quick turnaround, ease of use, and amenability to large scale production.
The high-specificity serology test is also available in countries accepting the CE mark, and the company has begun shipping the test globally.
Data amassed by analytics firm Diaceutics suggests fewer patients are coming into healthcare facilities and missing the chance for diagnosis, molecular testing, and treatment.
Illumina had sought to exclude the Harmony test from the US Market, while Ariosa had sought to overturn the jury verdict with a post-trial maneuver.
On the company's earnings call on Wednesday Roche provided some details about its work on a serology test to determine immunity for patients who have had COVID-19.
Emergency testing related to the SARS-CoV-2 pandemic strongly increased, but routine testing declined due to fewer regular health checks.
The test, which is used to screen for cervical cancer, was previously approved by the agency for use with the Cobas 4800 system.
The PCR-based tests, which detect SARS-CoV-2 nucleic acid, are limited to use in the labs where they were developed, according to the FDA.
The new rate applies to clinical diagnostic lab tests using high-throughput technologies that can process more than 200 specimens per day.
Seegene said Monday that the Health Canada approval will enable hospitals and licensed labs there to run the assay immediately for high-volume testing.