BioPorto Diagnostics A/S (CPH:BIOPOR) has gained the CE mark in Europe for its NGALds test, the first based on the group's proprietary Generic Rapid Assay Device (gRAD) platform for the development of lateral flow assays.
The NGALds test is designed to deliver a semi-quantitative NGAL (neutrophil gelatinase-associated lipocalin) result in under 15 minutes, without the need for laboratory instrumentation or complex user training. This makes it ideal for near-patient settings such as physician offices and urgent care clinics, where a quick assessment of the risk of kidney injury can help clinicians to better triage patients.
As an outpatient test, it will complement in-patient hospital use of BioPorto’s automated assay, The NGAL Test.
“I am very pleased with the rapid progress of NGALds, and of bringing the first test developed with our gRAD platform to market. As the first in a series of gRAD-based tests that we are creating, including tests for SARS-CoV-2 (COVID-19) and sepsis, it highlights the capabilities of gRAD. It also reinforces our focus on kidney disease, emphasizing the versatility of our NGAL technology and our commitment to improving kidney health through better diagnostics,” said Peter Mørch Eriksen, CEO of BioPorto in a statement.
The group said the commercial launch of the NGALds test will be initiated immediately in Europe through BioPorto’s distribution partners and the company’s sales team. At a later stage, BioPorto plans to seek regulatory approval of the test in other markets, it added.
SARS-CoV-2 point-of-care test completed
In parallel with the development of NGALds, BioPorto said it has also implemented an accelerated gRAD development process to create a rapid test for the SARS-CoV-2 virus which causes coronavirus (COVID-19). The goal is to offer a simple test that can quickly and accurately identify infected patients using a non-invasive sample, delivering a result in under 15 minutes, at a price significantly less than molecular tests.
After completing successful antibody pairing, device prototyping and production agreements, on December 23, 2020, BioPorto said it provided test kits to the University of California, Davis in the US to test samples from approximately 150 COVID-19 patients.
Results are expected in early 2021 and, if positive, BioPorto said it plans to proceed with steps to submit an Emergency Use Authorization (EUA) request to the US Food and Drug Administration (FDA) and a CE mark filing in the EU for the COVID-19, gRAD-based test.
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