FDA and EU filings for blood-based circulating tumor cell diagnostic are projected for 2013.
Cancer diagnostics firm Parsortix signed a two-year agreement with the Cancer Research UK-funded Paterson Institute for Cancer Research to help accelerate development of the firm’s circulating tumor cell (CTC) biomarker platform. The Paterson Institute has expertise in validating biomarkers based on CTCs, and Parsortix’ partnership with the Institute’s Clinical and Experimental Pharmacology Group (CEP) will provide expertise to facilitate development and commercialization of its CTC capture device.
The collaboration will have a number of aims, according to Parsotix, which is 90% owned by technology commercialization firm Angle. These include conducting cancer patient blood studies to independently confirm performance of the Parsortix device and optimize its design, develop research and clinical applications using cancer biomarkers, evaluate the Parsortix cassette CTC in comparison with other CTC platforms, and carry out comparative studies to support future regulatory submissions in the EU and U.S.
Parsortix separation device enables the isolation and identification of very rare cell types in blood including CTCs based on parameters such as size, shape, and deformability. The approach doesn’t rely on antibody binding, like other cell-separating platforms, which the firm says reduces the likelihood of false positives or false negatives.
“The Parsortix cell separation technology offers the potential for improved capture of CTCs from cancer patient blood and, since it does not rely on antibody affinity capture, has the potential to be both more effective and more widely applicable than existing techniques,” comments Caroline Dive, Ph.D., group leader for clinical and experimental pharmacology at the Paterson Institute. “We hope to be able to recover viable CTCs from the Parsortix device and be able to detect useful predictive and/or pharmcodynamic biomarkers, which will enable both an improvement in patient treatment and better targeted, more effective clinical trials of new cancer drugs in the future.”
Angle says it projects establishing sales of the Parsortix product for research purposes as early as mid 2012. The ultimate aim is to file for FDA and European approval of the product by mid 2013 for clinical use in the early detection of cancer and treatment-related or posttreatment monitoring of cancer patients.
The Parsortix platform is in addition capable of isolating intact fetal cells in peripheral maternal blood, and work is separately ongoing to develop the technology as a noninvasive alternative to amniocentesis and chorionic villi sampling for fetal diagnostics.