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Signal Genetics to Buy ChipDx, Gaining Cancer Test Pipeline, Bioinformatics Resources

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This article has been updated from a version posted Feb. 3 to include comments from Signal Genetics and ChipDx executives

Two New York diagnostic firms developing tests on the Affymetrix GeneChip platform joined forces last week, when Signal Genetics announced an agreement to acquire all of the assets of ChipDx, including prognostic tests for lung, breast, and colon cancers, as well as a predictive algorithm, web-based interface, and IP.

Both companies are privately held and did not disclose financial details of the acquisition. Greg Richard, executive vice president of sales and marketing for Signal, told BioArray News this week that his company made the transaction to "expand and enhance our pipeline and product portfolio."

It is the second such deal for Signal in the past year: In July, Signal announced a five-year, $13.3 million collaboration with Quebec City-based DiagnoCure. Under that agreement, Signal acquired DiagnoCure's US Clinical Laboratory Improvement Amendments-compliant service laboratory and was granted a worldwide exclusive license to its Previstage GCC Colorectal Cancer Staging Test (BAN 7/5/2011).

Signal in 2010 launched a gene-expression test called My PRS for stratifying multiple myeloma patients between those with high and low risk for relapse and overall survival. Last month, the company launched a second test called MyPRS Plus to provide more genetic information on each patient. Signal subsidiary Myeloma Health offers the tests (BAN 12/10/2010).

Signal is also the parent company of Respira Health, which focuses on lung cancer tests; and CC Health, which will market tests for colorectal cancer.
In its latest deal, Signal gains ChipDx tests BreastGeneDx, LungGeneDx, and ColonGeneDx. BreastGeneDX uses a 200-gene predictive gene expression signature to identify a patient's risk of disease recurrence for up to 10 years, according to ChipDx's website. The company's predictive algorithm has been validated by analyzing approximately 1,000 patients from multiple treatment centers, including individuals with ER-positive, ER-negative, and lymph node-positive and -negative tumors, the firm claims. The test also identifies the molecular subtype of a patient's tumor as basal, luminal A/B, HER2, or triple negative.

Richard said that Signal hopes to launch BreastGeneDx by the middle of this year. Once available, the test will compete with other multivariate assays for breast cancer recurrence prediction, such as Genomic Health's Oncotype Dx and Agendia's MammaPrint. Last year, ChipDx published a comparison of its assay and Oncotype Dx's assay on its website.

Based on an earlier study that compared OncoType assessments of breast cancer risk to clinical outcomes in a cohort of patients who did or did not receive adjuvant tamoxifen therapy, ChipDx performed the same statistical analysis on a similar series of patients, analyzed with its 200-gene signature. The company concluded that both methods were "statistically significant and independent of tumor size and grade."

Signal is also considering combining some of its internal test development programs with ChipDx's. Richard said that the company hopes to have a lung cancer test, "either from the Signal pipeline, the ChipDx pipeline, or both," by the end of this year. On its website, ChipDx claims its LungGeneDx test can classify early-stage lung adenocarcinoma patients as high or low risk for relapse, and predict response to the chemotherapy drugs cisplatin and vinorelbine. The firm has not provided additional information on the test.

Richard added that Signal might decide to pair its colon cancer test development effort with ChipDx's. ChipDx has developed ColonGeneDx, a 163-gene signature test that stratifies colon cancer patients into high- and low-risk recurrence groups. He did not provide a timeline for when this third test could become available.

BioArray News spoke with ChipDx CEO Ryan van Laar in December 2010 about ChipDx's pipeline (BAN 12/10/2010). Van Laar will now join Signal as head of bioinformatics, and all of ChipDx's employees will join Signal, which currently has 25 employees, according to Richard. Prior to founding ChipDx, van Laar worked at Agendia as a senior bioinformatician from 2005 to 2008.

Signal CEO Joe Hernandez said in a statement that the addition of ChipDx's bioinformatics capabilities is also an important component of the deal as they "drastically reduce our time to market." He specifically mentioned ChipDx's web-based interface, which will "be used to enhance Signal's physician web portal and allow for remote interpretation of test algorithms."

Van Laar told BioArray News this week that ChipDx's setup includes an Affymetrix GeneChip quality control system designed for clinical use, and is compliant with the US Health Insurance Portability and Accountability Act of 1996 for securely storing patient information.

Hernandez also said that the addition of ChipDx and its test menu will "provide economies of scale" to MyPRS Plus. Richard explained that by adding ChipDx's menu to its offering, Signal can "optimize our lab facilities by running more than one Affy-based test in them." When asked if Signal plans to continue offering tests on the GeneChip platform, Richard said the firm would "to the extent that they are gene expression assays." Van Laar added that the company plans to use microarrays for now, but will be "investigating other technologies in the future."

In the statement, Hernandez said that Signal would rely on its "recently established sales team as well as commercial partners to launch the acquired products." Richard clarified that since last August, Signal has invested in two new sales teams, one for its MyPRS test and one for its Previstage GCC in colon cancer. They are now "deployed nationwide," he said.

Signal currently maintains marketing partnerships with Caris Life Sciences, NeoGenomics Laboratories, and Pronto Diagnostics to sell its MyPRS test (5/31/2011). NeoGenomics markets MyPRS to hospital-based hematologists and oncologists in the US, while Caris markets MyPRS to community-based hematologists and oncologists. Pronto distributes MyPRS in Israel.


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