Risk and reward

Mira Dx licenses triple-negative breast cancer risk variant from Yale University

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NEW HAVEN, Conn.—Mira Dx, a spinoff company born from Yale University, announced in late February that it has licensed technology from the university based on the acceptance of a pivotal breast cancer study that appeared in the January issue of the journal Cell Cycle.

The study relates to the incidence of triple-negative breast cancers, the most deadly manifestation of the disease, which comprises somewhere between 15 and 20 percent of all incidences of breast cancer.

Mira Dx operates a CLIA lab out of New Haven, Conn., and currently runs a test to identify women at risk of epithelial ovarian cancer, PreOvar.

With the new published research, Mira Dx is prepared to charge forward into this new area, and attempt to tackle the problem of which far too many women live in fear.

Hundreds of thousands of women—and some men—in the United States are diagnosed with breast cancer each year. Nearly 40,000 die from the disease annually.

The researchers in the study reported in Cell Cycle honed in on three variants in BRCA1 that are polymorphic in breast cancer populations. The study reported that haplotype analysis including these variants revealed that breast cancer patients harbor five rare haplotypes not generally found among control groups.

Three of these rare haplotypes contain the key variant of BRCA1, rs8176318. These rare finds suggest that new genetic markers for breast cancer risk may have been found.

While numerous BRCA1 coding sequence mutations are associated with breast cancer risk, such mutations in BRCA1 account for less than 5 percent of breast cancer risk. The research identified microRNA-disrupting variants in and around BRCA1 that are polymorphic in breast cancer populations.

The key variant, rs8176318, shows significant cancer association for predicting the risk of developing triple negative breast cancer, especially for African-American women.

Now that published research points to success with the variant, Mira Dx will forge ahead with its own work in its area of specialization, microRNAs.

Mira Dx was formed in February 2008 by researchers at Yale University to discover gene-based laboratory tests conducted on newly discovered miRNAs. Mira Dx is applying miRNA discoveries to develop molecular diagnostics, which will provide individualized information on the likelihood of disease occurrence and response to certain types of therapy.

The Office of Cooperative Research at Yale's website says Mira Dx has obtained "initial seed funding." Numerous requests for comment to Yale went unanswered.

"There is a real need for tools that can help women who have a family history of breast cancer to better understand their risk," says Martin Van Verhoef, president and CEO of Mira Dx. "We are pleased to continue our advancements in the field of miRNAs in cancer risk and plan to make this information available to women in 2011 in the form of a new triple-negative breast cancer risk test."

Van Verhoef has led Mira Dx since November 2010. He says the company will also look at other cancers to battle over time. The company, he says, was created as a pathway to ensure that important, verified discoveries can be commercialized.

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