Duet with ALK and FISH

ABBOTT PARK, Ill.—Abbott and BioView Ltd. of Rehovot,Israel, have entered into an agreement in which BioView will develop automateddigital imaging software for use with Abbott's molecular diagnostic test todetect rearrangements of the anaplastic lymphoma kinase (ALK) gene in patientswith advanced non-small cell lung cancer (NSCLC).

The imaging software scans lung tissue specimens that havebeen tested for the ALK gene rearrangement with Abbott's fluorescence in-situ hybridization (FISH) technology.

Under terms of the agreement, BioView will perform theappropriate studies to obtain regulatory approval for its Duet AutomatedScanner to include an indication for automated imaging and analysis of Abbott'sVysis ALK Break Apart FISH Probe Kit.

Abbott plans to utilize the BioView product in its ownclinical trials for future regulatory approval for end-to-end automation of thepreparation, scanning and scoring of formalin-fixed paraffin-embedded (FFPE)non-small cell lung cancer tissue specimens, probed with the ALK Kit.

"We have pioneered the concept of tailoring workflows of ourinstruments to specific customer needs," says Alan Schwebel, BioView's CEO. Onthe technology side, he says, the company has asked the question, "How muchcost do you want to put into your instruments?" BioView has focused on small,state-of-the-art enhancements such as oil objectives and upgraded filters."Each one by itself may be small," Schwebel notes, "but when you put them alltogether, they make a difference."

"Automated imaging with the BioView system will assistpathologists in analyzing ALK FISH signals and help provide objective andactionable results to aid physicians in making informed treatment decisions forlung cancer patients," said John Coulter, head of Abbott's moleculardiagnostics business. "BioView has applied their technology successfully foruse with Abbott's PathVysion FISH test for breast cancer patients and UroVysionfor bladder cancer, and the technology offers exciting opportunities to furtherautomate FISH testing."

After receiving regulatory approvals, the parties plan toco-promote the BioView product worldwide, in compliance with applicableregulatory rules. In addition, the companies are exploring the possibility ofincorporating BioView Scanning Automation to further automate Abbott's futureFISH assay development.

The Duet System is intended for in-vitro diagnostic use as an aid to the pathologist in thedetection, classification and counting of cells of interest based on color,intensity, size, pattern and shape. Duet has U.S. Food and Drug Administration(FDA) clearances for the automated imaging and analysis of certainhematopoietic cells, amniotic cells, cells in urine specimens and FFPE breasttissue specimens.

BioView is engaged in clinical trials that will supportfuture global regulatory submissions for the use of the company's automatedscanning microscope and image analysis system with Abbott's Vysis ALK FISHtest. The imaging system is designed to scan specimen slides after FISHanalysis and enable automated enumeration to assist in determining fluorescentsignal counts in lung tissue samples. This can aid the pathologist indetecting, classifying and counting cells examined with the ALK FISH test onany computer screen and/or fluorescent microscope. The scans can be convertedinto electronic files for permanent medical records and allow consultationswith other physicians locally or remotely. In addition, Abbott plans to conductclinical studies to develop a version of the Vysis ALK FISH kit for use withits VP2000 Processor to automate the sample pretreatment steps.

Abbott's Vysis ALK FISH Probe test is FDA-approved and isalso available in South Korea, Japan, Israel, Canada and Europe as a companiondiagnostic, to detect rearrangements of the 2p23 chromosome of the ALK gene inNSCLC patients. The test is performed on lung tissue specimens with aready-to-use kit that includes positive ALK control slides and a probe that ispremixed with a buffer optimized for use in the formalin-fixed, paraffinembedded protocol.