February 13, 2007 »»» CS-Keys in Forefront of Fight Against Cancer Claire Deselle and Linda Malkas share a common passion: the development of methods to detect cancer at critically early stages, when treatments and cure rates are at their most successful. So it was natural the two -- who knew each other through a previous business project -- would team up again at CS-Keys. Deselle, CS-Key's chief executive, and Malkas, a co-founder and the company's lead researcher, are trying to create cancer-specific biomarkers that can diagnose malignant cells at very early stages. Breast cancer is CS-Keys' main focus, but the technology holds promise for other cancers, such as colorectal, prostate, ovarian and esophageal types. While CS-Keys is still relatively new -- it was formed in February 2005 -- the research it is based upon stretches back two decades, when Malkas was a biochemist researching how human cells replicate their DNA. Malignant breast cells replicate DNA differently than noncancerous cells, Malkas and her research team discovered. What they learned: Nonmalignant cells contain a basic protein, nmPCNA, while malignant cells have that protein in addition to its acidic variation, caPCNA. The key, then, became how to identify caPCNA within a cell. That's where the biomarker comes in. Malkas and company recently developed an antibody, caPCNAab, which specifically recognizes caPCNA in malignant breast tissue. "We had two different pathologists actually go and use it," Malkas said. "And, actually, it was very good at telling the difference, calling out cancer from normal cells. And it appears that it can pick up early disease." That exciting work in the laboratory led Malkas to co-found CS-Keys with her husband, Robert Hickey; Dr. Lauren Schnaper; and Derek Hoelz to find a way to apply that discovery in the real world. To help find commercial uses for the product, Malkas teamed with Deselle, who handles much of the hard work of running a startup, including raising venture capital. The company's first step was to acquire a license from Indiana University in February 2006 for the new technology. The CS-Keys team then approached BioCrossroads, which invested $285,000 through its $6 million Indiana Seed Fund. Next, Midwest-based Triathlon Medical Ventures agreed to an undisclosed seed investment as well. "That's really when the company took off, and that's when I came onboard full time," Deselle said. "We hit the ground running." Carrie Bates, a managing partner at Triathlon, sits on the board of CS-Keys. She cited three main reasons she decided to invest in the company. First, the biomarker CS-Keys discovered is an important cancer diagnostic tool that needs to be developed further. Secondly, it could have many commercial applications in the treatment of other cancers and for therapeutic products. And lastly, she said, she and her colleagues were "very impressed" with the co-founders of CS-Keys and its management. Her company is working with Deselle now to arrange more funding. "This can influence the way doctors do their jobs," Bates said. "It also could have many applications using the same core research done by the co-founders." CS-Keys' biomarker for diagnosing breast cancer employs a stain used by pathologists. The stain turns cancerous cells in breast tissue brown, making them stand out under a microscope. Without the stain, it can be difficult for pathologists to distinguish cells that pose a cancer risk, Deselle said. Benefits to using the stain could include earlier, faster and more accurate diagnoses. Another benefit of the biomarker: It could lessen the anxiety felt by patients when a pathologist is unable to make a definitive diagnosis and must resort to a watchful, and often long, waiting period. Deselle and Malkas hope to enter clinical studies for the biomarker/breast-cancer connection by the end of the year. Approval by the Food and Drug Administration could take another two years after that. Moving forward in the fight against cancer can't happen soon enough for them. "This is really a passion for us," Deselle said. "When we talk about this to people, we have never met anyone who isn't somehow touched by cancer. Everybody has a cancer story." Malkas knows this all too well, both through her work and from a personal standpoint: She lost her father to the disease. "If I had one goal," she said, "and I have said it out loud in many forums, long before I ever knew there was going to be a CS-Keys, if we can make a few less tears because of cancer . . . that's something that will help right there." Back to NEWS HEADLINES