OpGen's Collaboration With Henry Ford Hospital's Hermelin Brain Tumor Center Will Enable Researchers To Determine Effectiveness of Drug Therapies For Patients.

Business Editors

MADISON, Wis.--(BUSINESS WIRE)--Feb. 19, 2004

Single Molecule DNA Mapping Pinpoints Genetic Variation

OpGen, Inc., the leader in single molecule DNA analysis technology, today announced that it has commenced an Optical Mapping study of a deadly type of brain tumor, known as oligodendroglioma. OpGen is working with the Hermelin Brain Tumor Center, a division of the Henry Ford Health System in Detroit, and Professor David C. Schwartz of the University of Wisconsin, Madison, inventor of Optical Mapping.

Optical Maps will enable researchers to pinpoint and characterize lesions in the genome to determine what is happening at the DNA level and how well a patient will respond to treatment.

According to Dr. Bogler, associate scientist at the Hermelin Center, and the cancer biologist driving this effort, chromosomal deletions of chromosome 1p and 19q correlate strongly with response to a range of therapies. "It is crucial to understand the nature of these rearrangements," said Dr. Bogler. "The fact that these deletions affect response to such different treatments, including various drug combinations and radiotherapy, indicates that something fundamental is going on here, and understanding these events could be crucial in developing new treatments for this, and possibly other lethal cancers."

However, it has not been possible to identify the critical genes using current technologies. "One of the main challenges is that the pieces of DNA involved in the 1p/19q mutation are very large," added Dr. Bogler. "OpGen's unique analysis system is very elegant and simple and perfectly fills a niche between actually sequencing all of the DNA, which would take years and be prohibitively expensive, and what we have been doing, which is using PCR reactions to sample small islands along the chromosome."

"My personal interest, for a number of years, has been to develop single molecule systems to discern at high resolution, chromosomal aberrations involved in cancer," said Dr. David C. Schwartz, Kellett Professor of Genetics and Chemistry at the University of Wisconsin, Madison and a founder of OpGen. "Our goal in this project has been to put together a diverse and synergetic team of investigators to add new functionality to the Optical Mapping platform that will be able to pinpoint the molecular underpinnings of cancer from any type of solid tumor or other forms of cancer--we intend to demonstrate this capability by conducting the first high-resolution scan of this tumor."

OpGen and Professor Schwartz have been working with a group of statisticians and mathematicians, which include Dr. Michael Waterman, Professor of Biological Sciences and Mathematics at the University of Southern California. Dr. Waterman, a member of OpGen's Scientific Board, is helping to develop new algorithms to bring out all genetic variations that occur in gliomas.

In addition to the 1p/19q deletions, OpGen's genomic analysis system may also allow Hermelin Center's researchers to identify additional genome rearrangements affecting outcome and treatment response and to study other primary and metastatic brain tumors. The Hermelin Center is sending tumor samples to be analyzed by OpGen and Professor Schwartz to construct the first optical maps. OpGen plans to analyze multiple tumor samples within the next two years and has applied for additional funding to expand the study.

"David's vision is to be able to analyze EVERY patient's genome quickly and cost-effectively, to identify new drug targets and diagnostic products, and this collaboration represents another significant step forward towards that goal," said Colin Dykes, OpGen's Chief Scientific Officer. "The ability to identify changes in single molecules, each representing different cells in the tumor, offers a unique perspective on this disease that can help doctors to select appropriate treatments and dosage, and support new approaches to both drug discovery and drug development."

"We hope that the information gleaned in this early stage will eventually lead us to an understanding of which genes are involved so that we can understand the biological basis of gliomas," added Dr. Bogler. "If we can find a way to make brain tumors more sensitive to treatment, then that would open the door to new therapies and new approaches."

Currently, the standard treatment for brain tumors is surgery to reduce the mass and release pressure on normal tissue pushing on the skull. The surgery is then followed-up by chemotherapy treatments. About 20 percent of the 20,000 primary brain tumors diagnosed every year in the U.S. are oligodendrogliomas.

OpGen, Inc. is commercializing technology that will revolutionize modern medicine by providing the first means for rapid, cost-effective comparison of whole genomes in populations. Such whole genome analysis will enable practical pharmacogenomics, forensic microbiology, and whole genome molecular diagnostics. Optical mapping, the technology that makes this all possible, is the first and only publicly validated system for single DNA molecule analysis. OpGen, Inc. uses optical mapping to produce information across whole genomes in a single, cost-effective manipulation, with no requirement for prior sequence information, PCR, synthesis, cloning or probes. This information can be used for DNA sequence validation, comparative genomics, biodefense, and molecular diagnostics. For more information, please visit the Web site at www.opgen.com.