Early-stage in vitro diagnostics company Martell Biosystems is seeking approximately $3 million in venture capital to help set up shop in downtown Rochester, MN, to develop a noninvasive, DNA amplification-based blood test to diagnose breast and other types of cancer. Martell needs the funding to finalize a licensing deal for the core technology with the University of Pennsylvania, where it was developed, according to Phil Messina, the company’s president and COO. “We’ve signed a definitive term sheet with [UPenn],” Messina says. “The final licenses will be signed when we secure the capital for the company.” Martell’s core technology — fluorescent amplification catalyzed by T7 polymerase technique, or FACTT — was developed by Mark Greene, MD, PhD, John W. Eckman professor of medical science at UPenn, and Hongtao Zhang, a research assistant professor of pathology and laboratory medicine.
In FACTT, a capture antibody binds to an antigen of interest in a sample. A biotinylated detection antibody then binds to a non-overlapping epitope on the antigen, and streptavidin is used to link this detection antibody to a biotinylated, double-stranded DNA molecule that serves as the amplification module. Next, the amplification module is transcribed by T7 RNA polymerase, producing multiple copies of RNA from the DNA template and amplifying the signal in a linear fashion. Finally, a fluorescent dye is used to detect the amount of RNA, which is directly proportional to the amount of antigen in the original sample. Martell is billing FACTT as a more sensitive version of enzyme-linked immunosorbent assays, which still represent the gold standard of immunoassay-based clinical testing but are limited to nanomolar concentrations of antigen, according to the company. FACTT can detect sub-femtomolar concentrations of antigen — about 100,000 times as sensitive as ELISA, Messina says. Consequently, the technique can be used to detect exceedingly small amounts of protein in a sample and serve as the basis for noninvasive blood tests for various diseases.
“We’re starting with the HER-2 biomarker [for breast cancer], which is measured on the surface of the tumor cell but is also present in very small amounts in the blood,” Messina says. The company believes that noninvasive diagnostic tests based on FACTT will dramatically enhance the ability to detect tumors early, when treatment can be most effective. Because the presence of HER-2 is indicative of tumors that may respond to treatment with Herceptin, early and accurate detection of the biomarker could help identify HER-2-positive tumors earlier than mammography, reduce the need for invasive biopsies, improve selection of patients for Herceptin therapy, and help monitor therapeutic response to the treatment, according to Messina.
UPenn owns one published patent and several patent applications surrounding FACTT. Once the licensing deal is finalized, Martell hopes to begin developing and validating the breast cancer test, with the ultimate goal of obtaining reference lab certification from Minnesota and 510(k) clearance from the U.S. Food and Drug Administration, Messina says. Martell’s license with UPenn also is expected to cover veterinary applications, “so that’s a possibility,” Messina adds. “But right now we are focused on breast cancer with ovarian cancer to come next.”
Source: GenomeWeb