Centocor Inc. officials, seeking unmet diagnosticmarkets, determined pathologists weren't performingcertain tests because of time and specificity limitations.Their answer: the Rapid Rare Event Detection system, orRRED.
The system is being developed to rapidly identify andcharacterize rare events _ such as occult tumors or fetalcells in maternal blood _ giving it an advantage in someapplications over flow cytometry or polymerase chainreaction.
Centocor, of Malvern, Pa., showcased the newdiagnostics platform for the first time at the recentAmerican Society of Hematology meeting in Seattle. It isbeing developed in collaboration with XL Vision Inc., aSebastian, Fla., developer of electronic imaging products.
Centocor is providing diagnostic reagents while XLVision developed the computer-controlled microscopethat quickly can scan for rare events. "We do the reagentsthat can light up the cells so the microscope can findthem," said Jerry Fishlin, Centocor's director of cellularanalysis.
In oncology, the lead application area, the systempotentially could detect hidden tumor deposits in bonemarrow, blood and lymph nodes for a number of tumortypes; quantify tumor cells in marrow or blood duringtherapy; analyze stem cell harvests for removal of allresidual tumor cells; and aid in the selection andevaluation of patients in trials.
The second expected application of the technology wouldbe for the detection and analysis of fetal cells for prenatalgenetic testing. Infectious diseases is a third potentialtarget area. The process is adaptable to the detection ofboth antigens and nucleic acids.
"Nobody has had the time or resources to really identifyrare events, cells that happen one in a million or evenmore," Fishlin said. "Using this technology we're goingto be able to detect minimal residual disease to an extentnobody has done before. This has the potential to gobeyond polymerase chain reaction with a higher degree ofsensitivity. Not only will you be able to characterize acell, you will retain the image."
Diagnostics, particularly using monoclonal antibodies,has provided a foundation for Centocor's since the early1980s. The company's diagnostic royalty revenues nowtotal about $40 million per year.
"The therapeutics are starting to get approved and we'relooking at the diagnostics division to see where we cancreate synergies," said Timothy Cost, Centocor's seniorvice president, investor relations and strategic operations."The RRED is complementary to our cancer program.
"We tried to develop a technology to fit a market need,"Cost said. "We think it's an excellent technology, animportant platform for the company. Now it's a matter ofgoing out there and seeing what the market will be."
Centocor currently is seeking marketing partners forRRED, as it does for all its products.
Fishlin said Centocor has developed several workingprototypes. The system now is being set for testing in betasites in the U.S. and Europe, where proof-of-principlestudies will involve, among other things, relapsepredictions from blinded archive slide material. Reagentsmade specifically for the system will be tested. "Once weput it through that first challenge in the real world we'llstart some clinical trials," Fishlin said.
He said RRED could be on the market as early as 1997. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.