The company also said that it had received EUA from the US Food and Drug Administration for a non-prescription version of its COVID-19 sample collection kit.
The products combine next-generation sequencing and analysis with the company's NGSengine software to provide high-resolution HLA genotyping information.
The firm said its test eliminates the need for automated extraction systems in a high-volume PCR laboratory, reducing processing time, cost, and labor.
The company, which had received a request from the FDA for more information on the test, is planning additional studies before resubmitting the application.
The firm's CEO said that the deprioritization of its submission for a standalone SARS-CoV-2 assay running on its Verigene I molecular diagnostic instrument is puzzling.
While the tests from Clinomics, UPenn, and Inno Diagnostics detect the SARS-CoV-2 virus, Princeton BioMeditech's test differentiates between SARS-CoV-2 and influenza.
The test uses primers and probes from Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit with a modified results interpretation algorithm.
Reuters reports that France is to recommend that people under 55 who received one dose of AstraZeneca's SARS-CoV-2 vaccine receive a different vaccine for their second dose.
