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Martell Biosystems Seeks Investors to Develop Non-Invasive Breast Cancer Dx

NEW YORK (GenomeWeb News) – Early-stage in vitro diagnostics company Martell Biosystems is seeking approximately $3 million in venture capital to help set up shop near the Mayo Clinic in downtown Rochester, Minn., to develop a non-invasive, DNA amplification-based blood test to diagnose breast and other types of cancer, according to a company official.

Martell also needs the funding to finalize a licensing agreement for the core technology with the University of Pennsylvania, where it was developed, Martell President and COO Phil Messina told GWDN recently.

"We've signed a definitive term sheet with [UPenn]," Messina said. "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, a professor of pathology and laboratory medicine 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.

Then, 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.

According to Martell, FACTT can detect sub-femtomolar concentrations of antigen — about 100,000 times as sensitive as ELISA, Messina said.

The upshot is that the technique can be used to detect exceedingly small amounts of protein in a sample, and thus serve as the basis for non-invasive 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 said. "When you have very low concentrations of blood analytes, you need a very sensitive and accurate way of detecting them.

Messina said that the company believes that diagnostic tests based on FACTT will allow tumor detection as early as seven days and, more importantly, will be non-invasive.

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 Martell.

FACTT also will likely be compatible with high-throughput, liquid-handling robots, and as such Martell has had preliminary discussions with a few vendors in that space about potential collaborations, Messina said, though he didn't elaborate.

Thus far Martell has received nearly $500,000 in funding from local angel investors and through grants and loans from the state of Minnesota and city of Rochester, and is looking to tack on about $100,000 more to complete its first financing round, Messina said.

That would allow the company to finalize a lease on approximately 4,500 square feet of space within the Minnesota BioBusiness Center, an eight-story, 124,000-square-foot facility located adjacent to the Mayo Clinic and housing the Mayo Foundation for Medical Education and Research as its anchor tenant.

Martell hopes to move into the space in the spring, and turn it into R&D labs, office space, and eventually a CLIA-certified reference lab, Martell said. "We've been working on this with the city of Rochester for about the last nine months," he said. "We received some nice incentives to move there, and of course the Mayo Clinic is a big draw for us because we need a large pool of talent nearby."

And although Martell has no formal relationship with the Mayo Clinic as yet, the company has begun discussions with various researchers within the clinic's Cancer Center about how it can play a role in helping Martell develop its FACTT-based diagnostic tests.

UPenn owns one published patent and several patent applications surrounding FACTT, to which Martell will own the rights once it brings in additional venture capital funding.

Once the licensing deal with UPenn is finalized, Martell hopes to begin developing and validating the breast cancer test in its newly leased lab space, with the ultimate goal of obtaining reference lab certification from Minnesota and 510(k) clearance from the US Food and Drug Administration, Messina said.

He also said that Martell's business plan anticipates that the company will be acquired within three to five years, and will be logging more than $40 million in sales for a 15 percent market share after five years.

Martell's license with UPenn also is expected to cover veterinary applications, Messina said, "so that's a possibility. But right now we are focused on breast cancer with ovarian cancer to come next." In addition, Messina noted that the company is eyeing future development of a colon cancer diagnostic.

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