KIYATEC Inc., a pioneer in patient-specific cancer diagnostics, has achieved two major regulatory milestones that strengthen its position in the precision oncology landscape. The company's laboratory has secured both the prestigious College of American Pathologists (CAP) accreditation and New York State approval for its innovative 3D Predict diagnostic platform.
Advancing Laboratory Excellence
The CAP accreditation, widely regarded as the gold standard in laboratory quality assurance, validates KIYATEC's commitment to maintaining exceptional standards in laboratory operations. This certification, combined with the company's existing CLIA certification (Certificate #42D2130169) and established CPT Code (0248U), reinforces the clinical reliability and accessibility of their diagnostic technology.
Revolutionary Approach to Cancer Treatment Planning
KIYATEC's proprietary 3D cell culture platform stands out as the only technology supported by peer-reviewed evidence demonstrating correlation between its therapeutic response predictions and actual patient outcomes. This breakthrough represents a significant advancement in functional precision oncology, moving beyond traditional one-size-fits-all approaches to truly personalized treatment strategies.
Impact on High-Grade Glioma Treatment
The platform's approval holds particular significance for patients battling high-grade gliomas, including glioblastoma, where therapeutic advances have remained stagnant for decades. The 3D Predict Glioma test provides oncologists with crucial insights for treatment decision-making, marking the first meaningful progress in this challenging area of oncology in years.
Clinical Implementation and Future Directions
"We're thrilled to see our 3D Predict platform gaining this recognition," stated Eric Perreault, CEO of KIYATEC. "These approvals mean so much because they're not just about validating our science – they're about making a real difference in patients' lives. I'm passionate about ensuring that more patients and their doctors have access to the personalized insights these tests provide."
The platform's unique ability to predict individual patient responses to specific cancer therapies represents a paradigm shift in oncology diagnostics. By analyzing live tumor cells in a three-dimensional environment, KIYATEC provides oncologists with actionable data to optimize treatment selection and potentially improve patient outcomes.