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Progenika Biopharma Lands CE Mark for NGS Familial Hypercholesterolemia Test

NEW YORK (GenomeWeb) – Grifols subsidiary Progenika Biopharma today announced it has received the CE mark for its Seqpro Lipo IS next-generation sequencing-based diagnostic assay for familial hypercholesterolemia.

The kit is the first NGS-based test for the disease, which affects roughly one in 300 people and is characterized by high levels of LDL cholesterol, the firm said in a statement. The test looks at six genes associated with the condition: LDLR, APOB, PCSK9, APOE, STAP1, and LDLRAP1. Progenika said that it can run 96 patient samples at once on the Illumina MiSeq sequencer, which reduces operating time.

Progenika added that its CLIA-certified US laboratory has provided genotyping services in clinical trials for anti-PCSK9 drugs for familial hypercholesterolemia.

Last year, Progenika received CE-IVD certification for its ID Core XT bead array-based molecular blood group typing assay.