by Denny Lam
To date, a prototype has been developed and tested with success. It will be manufactured and available for purchase November-December 2017. The PRS has been listed with the FDA Class 1 as a slide by slide calibrator.
The College of Pathology has long sought a product like our PRS because they realize there is a high rate of failure in IHC staining which leads to misdiagnosis.
A recent paper, An Audit of Failed Immunohistochemical Slides in a Clinical Laboratory: The Role of On-Slide Controls, found that the failure rate of IHC staining can be as high as 9%. (Department of Pathology, Laboratory Medicine Program, University Health Network †Department of Laboratory Medicine and Pathobiology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada Keck School of Medicine, University of Southern California, Los Angeles, CA.) The paper concludes that in the era of automated IHC staining platforms, on-slide controls allow for the proper identification of IHC slides that should be failed by the IHC laboratory. For this reason, on-slide controls represent a powerful tool for preventing the reporting of false-negative/false-positive tests.
We will be exhibiting our PRS solution at International conferences for pathology this year, including:
The image above shows part of our design for the machine producing our PRS. All drawings are now completed. The machines are under construction and we expect them to be finished by September 2017.
Jee Shum, Chief of R&D
Mr. Shum has more than 40 years experience in product manufacturing, which has included stadium class light message boards, computers, pick & place assembly robotics, and laser engraving. Mr. Shum has owned and managed a number of successful companies both in the USA and foreign, with the most recent being American PC. Additionally, Mr. Shum is experienced in negotiating and managing manufacturing in China.
R&D efforts have included:
Frederick Husher, Chief of R&D
Mr. Husher has more than 40 years experience in R&D, product development, and business development. Mr. Husher has worked for Tektronix, University of New Mexico, Megiddo, US Military Joint Services, Amtech, Gtech, Beckman Coulter, Veracel, Barfield EADS, JAF Development Corp, and Crane Cams in various Electrical Engineering and Management positions.
R&D efforts have included:
The Process Record Slide (PRS) contains an array of immunohistochemical (IHC) reactive targets that are co-resident with an applied patient tissue section. Both the target array and patient tissue section go through the full IHC processing experience together. The target array's reactivity to one or more of the staining reagents records the cumulative experience of the co-resident tissue section. Human origin materials are not used as part of the target arrays. Thus, each PRS contains its own unique IHC processing experience record for the co-resident tissue section. Slide-to-slide analysis of the PRS array data can be used in quality control of the IHC process using statistical variance tracking. The PRS target array provides digital imaging with calibrating targets that uniquely expresses the staining experience of the co-resident tissue section.
With our PRS, you will be able to: