This story was first published on Dec. 11.
Arrayit Diagnostics has obtained an exclusive license to use ovarian cancer biomarkers identified at Wayne State University in a future test.
Under the agreement, Houston-based Arrayit Diagnostics, a majority-owned subsidiary of Sunnyvale, Calif.-based Arrayit, gains worldwide rights to develop and commercialize a protein microarray-based diagnostic using the biomarkers. They were developed by WSU researchers Michael Tainsky, Sorin Draghici, and Madhumita Chatterjee. Financial terms of the agreement with WSU were not disclosed.
Arrayit and WSU also began a research project to further develop the marker panel by screening a "much larger test population than previously studied in prior, related research projects." Tainsky, who is director of molecular biology and genetics at WSU's Karmanos Cancer Institute and professor of pathology at the university’s School of Medicine, will serve as principal investigator of the six-month project, Arrayit said.
Tainsky said in a statement that he and other WSU researchers have used Arrayit's technology to develop their biomarker set, and that the partners are in "late-stage development of a simple blood test for the early detection of ovarian cancer that holds tremendous potential to materially … impact the survivability and quality of life of ovarian cancer victims."
The deal with WSU is the latest in a string of collaborations initiated by Arrayit to jumpstart the diagnostics subsidiary it founded earlier this year. Arrayit believes such a test could enable clinicians to screen for early-stage ovarian cancer in asymptomatic women.
Ovarian cancer often presents with non-specific symptoms during its initial stages, and is diagnosed only when later-stage symptoms appear and the disease has metastasized, according to the National Cancer Institute.
In an e-mail to BioArray News, Tainsky noted that he and fellow WSU researchers have published several papers on their technique. For instance, a 2006 Cancer Research paper showed that the approach can pair high-throughput selection with array-based serologic detection of antigens that indicate the presence of cancer. High-throughput selection is accomplished by biopanning an ovarian cancer phage-display library using serum immunoglobulins from an ovarian cancer patient as bait, according to the paper's abstract.
In that study, protein arrays containing 480 selected antigen clones revealed 65 clones that interacted with immunoglobulins in sera from ovarian cancer patients but not with sera from healthy women or patients having other benign or malignant gynecologic diseases. This year, Tainsky and colleagues described the approach in Methods in Molecular Biology.
Based on an internal estimate, Arrayit said that the market for an early-stage ovarian cancer diagnostic test could exceed 66 million tests each year in the US and swell to 175 million when factoring in Western Europe and Japan.
Arrayit said that it plans to file a pre-market approval application for its diagnostic test with the US Food and Drug Administration in the "near future." If the test kit is approved, Arrayit Diagnostics will market and distribute it worldwide, the company said. Representatives from Arrayit did not respond to an e-mail seeking additional comment.
Arrayit opened its diagnostics subsidiary in Houston in August with the intent to commercialize several array-based tests for cancer, neurodegenerative diseases, and other disorders (see BAN 8/18/2009).
Since going public earlier this year, Arrayit has expressed an interest in the molecular diagnostics market. "There is a very large opportunity for Arrayit to participate in moving arrays from research into clinical diagnostic use," CEO Rene Schena told BioArray News in May. "That is one of our main focuses as a public company" (see BAN 5/12/2009).
Beyond the deal with WSU, Arrayit is involved in several other collaborations that could lead to future tests. In April, for instance, Arrayit announced a partnership with researchers in the neurodegenerative division of the Parkinson's Institute and Clinical Center, also located in Sunnyvale. The institute researchers will use Arrayit's Human Genome H25K array to look for biomarkers linked to Parkinson's disease (see BAN 4/14/2009).