Date: Jul 04, 2004 Source: NIH Success Stories (
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Technology Developed:
MarkPap technology (formerly CAP-PAP test) is a specific biomarker-based in vitro diagnostic investigational medical device for detection of abnormal cells in cervico-vaginal specimens. The biomarker is the cervical acid phosphatase (CAP), which is visualized as a red intracellular deposit on a bluish Papanicolaou background (PAP). It clearly highlights abnormal cells and serves as a "stop light" for sceeners to prevent overlooking abnormal cells. The test increases accuracy (better sensitivity, equivalent specificity) of cervical cancer screening.
Uses of Technology/Products/Service:
Cervical cancer is a preventable disease if detected on time. In spite of efforts and improvements, the rate of false-negatives is still high. Using MarkPap technology in two clinical laboratory trials on 2,000 subjects/specimens, we have seen 50% increase in detection of abnormal specimens and 50% decrease of false-negatives in comparison with the standard. The MarkPap Research Kit (manufactured by Ricca Chemical Company, Arlington, TX) and the MarkPap Solution are available for research purposes only in the US. The test is made very simple, customer-friendly and inexpensive that could be easily implemented in every laboratory performing Pap test.
Benefit to Company:
The financial support from NIH/NCI SBIR program was crucial for the development of MarkPap technology from an original idea to commercial products (test, kit and solution). SBIR phase-1 grants helped to prove the feasibility of the new concept on both slides and liquid-based specimens, and the phase-2 SBIR grant helped to prove the safety and efficacy of the new technology in comparison with the standard clinical practices. A Continuation phase-2 SBIR grant application, intented to acquire data required for FDA Pre-Marketing Approval, is pending review in July 2004.
How Product Was Commercialized:
BioSciCon is looking for partners to commercialize the technology for intended application.
Other Comments Related to Company's Success Story:
For the first time in Pap test history MarkPap technology introduces control slides for QC/QA. The screening time is also shorter, because of the marker, providing better productivity for less liability. Together with a better accuracy for lowerr cost, the new technology is intended to be used, after the FDA approval, for mass primary cervical cancer scereening to save women's lives and reduce the cost of health care.
