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Signal Genetics Gains CLIA Lab, Broadens Test Menu in $13.3M DiagnoCure Deal


This story has been updated to include comments from a company official.

By Justin Petrone

Signal Genetics and DiagnoCure this week announced a collaboration arrangement valued at $13.3M over the first five years.

Under the terms of the agreement, Signal Genetics 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.

New York City-based Signal paid $5.7 million to acquire DiagnoCure's West Chester, Penn.-based CLIA lab and will pay a minimum of $5.1 million in annual installments and royalty payments over the first five years of the license agreement.

In addition, Signal will pay DiagnoCure $2.5 million under an R&D agreement to advance genomic tests being developed in the Quebec City-based firm's laboratories. All payments will be made in cash.

Founded in 2010, Signal Genetics is the parent company for three subsidiaries: Myeloma Health; which offers myeloma-related diagnostics; Respira Health, which focuses on lung cancer tests; and the newly founded CC Health, which will market tests for colorectal cancer.

Signal Genetics launched the Myeloma Prognostic Risk Signature test, or MyPRS, last December via its Little Rock, Ark.-based CLIA laboratory. MyPRS is based on the Affymetrix GeneChip microarray platform and uses a gene-expression signature to predict a patient's progress and enable personalized treatment decisions, according to the firm.

Signal currently maintains a marketing partnerships with Caris Life Sciences and NeoGenomics Laboratories to sell its MyPRS test (BAN 5/31/2011).

Signal Genetics CEO Joe Hernandez said in a webcast conference call that the firm intends to maintain DiagnoCure's existing CLIA lab and retain its employees, but in the long term, it will make a decision as to "where we will locate that lab." He did not elaborate.

Greg Richard, the firm's senior vice president of commercial operations, told BioArray News this week that the deal will have no impact on Signal Genetics' operations in Little Rock.

As part of the new agreement, Signal Genetics will also directly market DiagnoCure's Previstage GCC Colorectal Cancer Staging Test. Launched in 2008, the assay provides prognostic information based on the tumor burden measured at the molecular level in the lymph nodes. The test is available through US and Canadian labs using PCA3 analyte-specific reagents from Gen-Probe, and in the European Union as the CE-marked Progensa PCA3 in vitro assay.

Yves Fradet, president and chief medical officer of DiagnoCure, said that the business collaboration with Signal Genetics was the "best strategic path" for the firm to further commercialize Previstage GCC. He said the deal will "strengthen DiagnoCure's financial base, and allow us to build on our core expertise in developing clinically relevant and robust genomic tests in cancer, in particular lung cancer."

Richard acknowledged that the firm has ongoing programs in lung and prostate cancer, "some of which will be diagnostic or prognostic using various genomic technologies, including microarrays."

Looking ahead with regards to test menu, he said that Signal Genetics' "near-term focus is on commercializing Previstage GCC," but if the R&D efforts result in new markers, it is an option that Signal Genetics will commercialize them in a similar manner.

Further details of the collaboration were not discussed.

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