Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine
Niki BioSolutions' subsidiary DiamiR Biosciences received NYSDOH CLEP approval to expand its APOE Genotyping test to dried blood spots, plasma, and urine specimens, on top of previously approved blood, buccal swab, saliva, and tissue. The new specimen types enable at-home or point-of-care collection with ambient-temperature shipping, removing phlebotomy and cold-chain requirements, and plasma compatibility allows APOE genotyping on the same sample used for the company's microRNA-based brain health assay.
Key figures
- Drug Name
- APOE Genotyping test
- Approval date
- 2026-10-23
- New specimen types
- ["dried blood spots (FTA card)","plasma","urine"]
- Initial clep approval
- August 2025
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