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The test was developed by Nal von Minden, which licensed its exclusive commercial rights in the US and Canada to Teracero.
The agency released two templates including a new one for developers of tests that detect or correlate to neutralizing antibodies against the coronavirus.
The company uses next-generation sequencing data to track the health of transplanted organs and stem cells over time.
The company's fourth quarter revenues rose to $12.7 million, while full year revenues rose to $42 million.
For the three months ended Dec. 31, the Boulder, Colorado-based firm reported revenues of $27.0 million compared to $8.3 million in 2019.
Still early in its clinical testing operations, the company shrank its net loss to $6.3 million or $.09 per share during the quarter.
The FDA said tests with strong performance in symptomatic patients can be authorized for over-the-counter use without first being validated in asymptomatic individuals.
The startup will use the funds to support R&D and to launch its Qsant urine test to help determine if a patient's body is rejecting a kidney transplant.
The survey found analysis, interpretation, and reporting requirements can take more than six hours per test but that reimbursement for tests doesn't account for this work.
The partners will assess Stella's assay by quantifying proto-oncogenes in Barrett's esophagus tissue that have progressed to cancer, and those that have not.