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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 automated digital imaging software for use with Abbott's molecular diagnostic test to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in patients with advanced non-small cell lung cancer (NSCLC).
The imaging software scans lung tissue specimens that have been tested for the ALK gene rearrangement with Abbott's fluorescence in-situ hybridization (FISH) technology.
Under terms of the agreement, BioView will perform the appropriate studies to obtain regulatory approval for its Duet Automated Scanner to include an indication for automated imaging and analysis of Abbott's Vysis ALK Break Apart FISH Probe Kit.
Abbott plans to utilize the BioView product in its own clinical trials for future regulatory approval for end-to-end automation of the preparation, 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 our instruments to specific customer needs," says Alan Schwebel, BioView's CEO. On the technology side, he says, the company has asked the question, "How much cost 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 all together, they make a difference."
"Automated imaging with the BioView system will assist pathologists in analyzing ALK FISH signals and help provide objective and actionable results to aid physicians in making informed treatment decisions for lung cancer patients," said John Coulter, head of Abbott's molecular diagnostics business. "BioView has applied their technology successfully for use with Abbott's PathVysion FISH test for breast cancer patients and UroVysion for bladder cancer, and the technology offers exciting opportunities to further automate FISH testing."
After receiving regulatory approvals, the parties plan to co-promote the BioView product worldwide, in compliance with applicable regulatory rules. In addition, the companies are exploring the possibility of incorporating BioView Scanning Automation to further automate Abbott's future FISH assay development.
The Duet System is intended for in-vitro diagnostic use as an aid to the pathologist in the detection, 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 certain hematopoietic cells, amniotic cells, cells in urine specimens and FFPE breast tissue specimens.
BioView is engaged in clinical trials that will support future global regulatory submissions for the use of the company's automated scanning microscope and image analysis system with Abbott's Vysis ALK FISH test. The imaging system is designed to scan specimen slides after FISH analysis and enable automated enumeration to assist in determining fluorescent signal counts in lung tissue samples. This can aid the pathologist in detecting, classifying and counting cells examined with the ALK FISH test on any computer screen and/or fluorescent microscope. The scans can be converted into electronic files for permanent medical records and allow consultations with other physicians locally or remotely. In addition, Abbott plans to conduct clinical studies to develop a version of the Vysis ALK FISH kit for use with its VP2000 Processor to automate the sample pretreatment steps.
Abbott's Vysis ALK FISH Probe test is FDA-approved and is also available in South Korea, Japan, Israel, Canada and Europe as a companion diagnostic, to detect rearrangements of the 2p23 chromosome of the ALK gene in NSCLC patients. The test is performed on lung tissue specimens with a ready-to-use kit that includes positive ALK control slides and a probe that is premixed with a buffer optimized for use in the formalin-fixed, paraffin embedded protocol.