Niki BioSolutions receives NYSDOH approval to add urine, plasma and dried blood spots to APOE test
Niki BioSolutions' subsidiary DiamiR Biosciences was granted Clinical Laboratory Evaluation Program (CLEP) approval by the New York State Department of Health. The approval expands the company’s APOE Genotyping test to include dried blood spots, plasma and urine specimens, in addition to the previously approved blood, buccal swab, saliva and tissue samples. The company said the new specimen types will enable at‑home or point‑of‑care collection and allow the test to be run on the same plasma used for its brain‑health biomarker assay.
Why it matters
The expanded specimen options could broaden the test’s accessibility and appeal to clinical trial sponsors and decentralized testing programs, potentially increasing test volume for Niki BioSolutions. The company indicated that the new formats may reduce collection barriers and support integrated genetic‑biomarker workflows.
Key facts
- 1The NYSDOH CLEP approval was dated October 23, 2026. stocktitan.net
- 2The approval adds dried blood spots (FTA card), plasma and urine to the list of approved specimens for the APOE Genotyping test. stocktitan.net
- 3The test was previously approved for blood, buccal swab, saliva and tissue specimens in August 2025. stocktitan.net
- 4Alidad Mireskandari, Ph.D., President and Chief Operating Officer of Niki BioSolutions, said the expansion advances the objective of making testing more accessible. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.