NEWS: Molecular Testing Company, ChromaCode, Gets Emergency FDA Approval For COVID-19 Test

A molecular testing startup has received Emergency Use Authorization (EUA) of its test for the coronavirus.

ChromaCode, with HQ in Carlsbad, first launched the test in April for hospitals and labs, in line with the FDA’s EUA regulations. See related article here.

“Customers continue to experience extraordinary increases in testing volume; our ability to enable labs to process thousands of samples in one day using existing laboratory equipment means they can rapidly scale testing to meet high demands,” Greg Gosch, ChromaCode’s co-founder and CEO, said in a recent press release.

The test is intended to detect severe acute respiratory syndrome coronavirus 2 from nasopharyngeal swab specimens from patients suspected by their healthcare provider of having contracted the coronavirus.

Later this year, ChromaCode intends to leverage its multiplexing tech to launch a similar test, but one that combines multiple respiratory viruses into a single test in anticipation of the upcoming flu season.

ChromaCode’s test, according to the company, enables “frictionless adoption” by running on standard instruments — with no hardware/software changes required.

Onsite training is not required as training is performed via a web-based application.

The company also claims that it provides “full security and data privacy with HIPAA compliant cloud software that does not store protected health information.”

ChromaCode’s platform is built on the use of data science tech — including proprietary signal processing techniques — and cloud-computing algorithms to boost the performance of commonly used molecular diagnostics instruments and reagents.

About The Author

Deirdre Newman is a long-time journalist, who's covered OC startups for a few years.

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