This article has been corrected to note that the OncoTect 3Dx technology is slideless and the sample size for the study is 10,000 rather than the previously stated 100,000.
NEW YORK (GenomeWeb News) – IncellDx today said that is partnering with BioReference Laboratories to conduct a study comparing the firm's OncoTect 3Dx technology with other Pap smear systems.
IncellDx's OncoTect 3Dx uses a proprietary flow cytometry-based technology to improve and automate processing and is slideless. The study is expected to evaluate the firm's technology versus liquid-based Pap smear systems, such as ThinPrep and SurePath, in over 10,000 samples. Menlo Park, Calif.-based IncellDx expects the study to last three to six months.
IncellDx and BioReference expect the study will provide sufficient data to plan a US Food and Drug Administration trial for the OncoTect 3Dx technology.
Bruce Patterson, CEO and founder of IncellDx, said that the liquid-based cytology market represents a $5 billion opportunity. "Our OncoTect 3Dx technology has the potential to increase the sensitivity and specificity of the liquid-based Pap smear while it simultaneously reduces the cost and turnaround time," he added.
Elmwood Park, NJ-based BioReference Laboratories is a clinical lab firm offering esoteric, molecular diagnostics, pathology, genetic, and women's health testing services. Its Chairman and CEO, Marc Grodman, also is chairman of the board of IncellDx.
Earlier this year BioReference invested $6 million in IncellDx.