NEW YORK — BioPorto said on Wednesday that it has received CE marking for its point-of-care NGALds kidney injury test.
The Danish firm also said that its test for SARS-CoV-2 is currently under clinical testing at the University of California, Davis, with results due in early 2021.
The NGALds test is designed to measure levels of neutrophil gelatinase-associated lipocalin, a diagnostic biomarker for acute kidney injury, within 15 minutes. It is based on the company's generic rapid assay device (gRAD) platform for custom lateral flow assay development and requires no instrumentation.
The company said the test is suited for near-patient use, complementing its automated NGAL Test, which already has CE marking.
BioPorto said that its SARS-CoV-2 test, which is also based on the gRAD platform, is being tested by UC Davis collaborators using samples from about 150 COVID-19 patients. Pending positive results, the company said it will submit this test to the US Food and Drug Administration for Emergency Use Authorization, as well as pursue CE marking.
In 2018, BioPorto announced an agreement with Roche for the global distribution of the NGAL Test for use with the Cobas c 501 and Cobas c 502 analyzers.