Visiopharm and Boston Cell Standards Announce Partnership to Develop Joint IHC Technology for Magnani-Taylor Regulatory Proposal
“The higher proposed assay requirements will raise the quality of IHC testing to ensure accurate results, which will benefit pathologists, oncologists and, ultimately, patients,” said Dr. Steven Bogen, CEO, Boston Cell Standards. “However, aligning IHC laboratory testing globally requires that labs have access to enabling quality assurance tools that, until recently, were not available -- calibration standards and image analysis quantification software to measure the calibrator test results.”
- Visiopharm and Boston Cell Standards today announced a partnership to develop a joint technology solution that enables labs to meet key provisions of regulatory changes proposed in a groundbreaking editorial recently published in Archives of Pathology & Laboratory Medicine.
- If adopted, the proposal would represent a significant shift in the IHC lab regulatory landscape, requiring labs to incorporate rigorous assay control methods and calibration.
- Modern clinical laboratory quality assurance protocols include reference standards, assay calibration, quantitative controls, and standardized units of measure.
- Visiopharm developed Qualitopix™, a groundbreaking AI-driven image analysis software for IHC assay control quantification and tracking (Levey-Jennings analysis).