Visiopharm and Boston Cell Standards have announced a partnership to develop a joint technology solution that enables laboratories to meet key provisions of regulatory changes proposed in a recent groundbreaking editorial.
In a July 2023 Archives of Pathology & Laboratory Medicine online editorial, Dr Barbarajean Magnani and Dr Clive Taylor proposed that clinical immunohistochemistry (IHC) quality assurance requirements mirror those of all other clinical laboratory assays. If adopted, the proposal would represent a significant shift in the IHC regulatory landscape, requiring labs to incorporate rigorous assay control methods and calibration. The editorial highlights the absence of quality assurance protocols from IHC and urges their adoption. Without these enabling tools, different IHC laboratories can – and often do – return different results from the same sample.
Pictured is a chromogenic IHC image of a normal kidney targeting the protein CD10.
“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 laboratories 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.”
In light of these potential regulatory changes, Visiopharm and Boston Cell Standards are partnering to integrate IHC calibration standards with image analysis software for quality assurance. Boston Cell Standards pioneered the industry’s first calibration standards. Visiopharm developed Qualitopix, a groundbreaking AI-driven image analysis software for IHC assay control quantification and tracking (Levey-Jennings analysis). Together, they represent the only commercial system capable of meeting the proposed higher assay regulatory requirements.
The companies are planning to complete the initial integration and start clinical testing in 2023.