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Biopix-T Gets CE Mark for Point-of-Care Platform, Molecular SARS-CoV-2 Test

NEW YORK — Greek molecular diagnostics company Biopix-T has secured a CE-IVD mark for its SARS-CoV-2 test, called COV19 qcLAMP kit, and for the point-of-care Pebble qcLAMP Platform it runs on.

Based in Heraklion, the capital of the island of Crete, Biopix-T was founded in 2019 to commercialize technology developed by researchers at the Institute of Molecular Biology and Biotechnology of the Foundation for Research and Technology – Hellas, or IMBB-FORTH.

The company's analysis device relies on real-time quantitative colorimetric loop-mediated isothermal amplification, or qcLAMP, and is being positioned as a rapid, precise alternative to real-time PCR, the standard technique for molecular SARS-CoV-2 testing.

Biopix-T obtained the CE-IVD marks for the assay and device under the European In Vitro Diagnostic Directive, which will remain in force until May 2022, when Europe transitions to the newer In Vitro Diagnostic Regulation.

According to the firm, its test has a turnaround time of 30 minutes. It relies on nasal, saliva, or pharyngeal swab specimens collected from patients. The handheld device weighs less than 300 grams and can be used to test samples at the point of need.

CEO George Papadakis said in a statement that the device could be used to provide results to "all points of care as well as other points of interest, such as airports, cruise ships, companies, community services, but also hotels, border entry points, or immigration hot-spots."

To support the product development and certification process, Biopix-T secured an undisclosed amount of initial funding from the Patras Science Park, located outside of Patras, Greece, as well as about €1.5 million ($1.7 million) in a round led by Athens-based Metavallon VC and Bulgaria's Eleven VC. The company also carried out a clinical study of its test with partners at the University Hospital of Heraklion in Crete, as well as assessment studies with the Hellenic Pasteur Institute of Athens and a private Swiss lab.

Additional clinical studies, supported by a €2.4 million European Horizon 2020 grant awarded last year, are underway.

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