NEW YORK — Telo Genomics, a developer of telomere-based cancer testing technology, said Tuesday that it has received Clinical Laboratory Improvement Amendment certification for its clinical laboratory from the US Centers for Medicare and Medicaid Services.
With the certification, Toronto-based Telo said it can offer its clinical laboratory services within the US, as well as develop, validate, and distribute TeloView — an image analysis software platform that uses the 3D features of telomeres as structural biomarkers of genomic instability at the single-cell level — in all jurisdictions that recognize CLIA accreditation.
"The CLIA designation is a game-changing milestone for Telo on its path towards commercialization," Jay Wohlgemuth, managing partner of Trusted Health Advisors, an adviser to Telo, said in a statement. "Offering the TeloView portfolio of tests as CLIA tests will empower the ongoing partnership development efforts with key industry players in the diagnostic landscape, particularly in respect to ongoing discussions in smoldering and minimal residual disease in multiple myeloma."
Telo has been developing TeloView for a range of applications including liquid biopsies for the prediction of multiple myeloma progression through a collaboration with the Mayo Clinic. It also recently struck a deal with contract research organization Emery Pharma under which the partners are jointly offering their cellular and molecular bioanalytical solutions for clinical research and development.