While ethnicity-based screening remains the consensus approach for identifying disease-causing mutations, the American population is becoming increasingly admixed, meaning that genetic laboratories often have to run multiple panels on the same individual.
The vote of confidence is a stepping stone for the company to seek 510(k) approval for an H1N1 test on its platform; to tackle the point-of-care diagnostic market; and to further develop tests for other infectious diseases.
By obtaining emergency use authorization from the FDA, Potomac Falls, Va.-based TessArae becomes the first array firm to have received an EUA to sell chips for the monitoring and early diagnosis of the H1N1 influenza A virus.
For TessArae, which specializes in developing pathogen-detection arrays, the deal with GeneDx is the first of its kind. The company said this week that it intends to pursue more opportunities in the genetic disease-testing arena.