Automated Scans of FISH Test Slides of Lung Cancer Cells Preserve Results, and Enhance Objectivity
ABBOTT PARK, IL, Nov. 28, 2012 – Abbott and BioView, Ltd. 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 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.
"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."
BioView is engaged in clinical trials that will support future global regulatory submissions for the use of BioView'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.
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.
About ALK FISH Testing
Abbott's Vysis ALK FISH Probe test is FDA-approved as well as 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.
FISH (fluorescence in-situ hybridization) technology has a variety of uses. It can identify whether too many, or too few, copies of a particular gene are present in the body's cells or whether certain genes have rearrangements that play an active role in disease progression. Since the technology works especially well for identifying genetic markers in solid tumors, cancer diagnostics are one of the fastest growing applications.
About Abbott Molecular
Abbott Molecular is a leader in molecular diagnostics – the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential to aid with early detection or diagnosis, can influence the selection of appropriate therapies, and may assist with monitoring of disease progression.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
More information about Abbott is available on the company's Web site at www.abbott.com.