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CombiMatrix Prepares Cancer Array for Launch, Inks Sales and Marketing Deal with Clarient

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By Justin Petrone

CombiMatrix Molecular Diagnostics will soon launch an array-based cancer diagnostic that contains "thorough coverage of all the key oncogenes and cancer-related chromosomal regions."

Called the DNAarray Oligo 180K Heme Profile, the new test contains content endorsed by the Cancer Cytogenomics Microarray Consortium, according to CombiMatrix CEO Judd Jessup.

Jessup told BioArray News this week that the Irvine, Calif.-based firm has completed validation of the Heme Profile test and is now providing testing services to a few customers ahead of a full launch in the US, expected later this month.

In regards to content, the probes of the microarray "contain thorough coverage of all the key oncogenes and cancer-related chromosomal regions" as recommended by the CCMC, Jessup said. The new platform was "designed to query thousands of cancer-specific oncogenes in conjunction with its genome-wide backbone coverage," he added.

The CCMC was formed in 2009 by a group of clinical cytogeneticists, molecular pathologists, and molecular geneticists who are interested in applying microarray technologies to cancer diagnosis and cancer research (BAN 11/30/2010).

The consortium has already developed some standards for cancer microarray designs. For instance, in December, the Cambridge, UK-based company BlueGnome launched a cancer-themed array based on the CCMC recommendations (BAN 12/24/2010).

CombiMatrix's test plans come as the company announced a sales and marketing partnership with Clarient, a GE unit that provides molecular-diagnostics services to pathologists and oncologists.

CombiMatrix said in a statement this week that it has given Clarient exclusive rights to sell CombiMatrix's oncology-related tests to commercial labs "based on certain minimum levels of sales."

The deal builds on an existing relationship between the two firms. In 2008, CombiMatrix granted Clarient rights to commercialize its array-based HemeScan test, which predicts the probable outcome of chronic lymphocytic leukemia at the time of diagnosis (BAN 3/11/2008).

In addition to HemeScan and the impending Heme Profile test, CombiMatrix offers the HERScan test for HER2 analysis in breast cancer patients and an array-based, post-prostatectomy prostate cancer-stratification assay. Clarient now has the rights to offer all of these tests to its customers.

Jessup said that Clarient "knows the cancer business" and has "tremendous reach throughout the US with sales representation and a large customer base." The new agreement also allows for an "active relationship" between the firms' medical and scientific teams that over time could "help to drive both the commercial adoption of DNAarray testing and the development of new companion diagnostics in the oncology space," CombiMatrix said in a statement.

Additionally, the collaboration will allow the companies to "engage in further research endeavors" and to "co-develop reporting tools that will … empower physicians to make more informed treatment decisions for their cancer patients."

Jessup declined to further discuss the details of the Clarient deal, though he said that CombiMatrix is open to similar deals regarding its tests that are not related to oncology.

CombiMatrix also offers BAC and oligo-based HDScan tests that identify congenital chromosomal abnormalities; a prenatal screen that assays amniotic fluid to identify genetic disorders in utero, and its ATScan test, which identifies copy-number variants associated with autism spectrum disorder. The company also began offering traditional karyotyping for prenatal samples this week.

"There is potential for other partnerships outside of pathology, such as [in] pre- or post-natal diagnostics," Jessup said, "but Clarient is our exclusive pathology partner."

CombiMatrix last week raised $6.7 million in a private stock placement. Investors who participated in the placement included HLM Venture Partners, members of CombiMatrix's management team and board, and other investors, CombiMatrix said in a separate statement. HLM Partner Marty Felsenthal joined CombiMatrix's board as a result of the investment.

Jessup said this week that the company will use the funds to expand its menu of tests. "We are putting our focus around the major cancer areas," he said, without elaborating.

When asked about the Comprehensive Cancer Array, a microRNA array-based cancer-screening tool touted as a molecular diagnostics "game changer" by Jessup's predecessor, former CEO Amit Kumar, Jessup said the test was no longer in development.

Kumar, who left CombiMatrix in June 2010 following a period of restructuring, had originally anticipated the CCA could reach the market by late 2010 (BAN 4/10/2009).

Kumar said he envisioned marketing the CCA to the 50 million people in the US who are at least 40 years old as part of routine physical examinations, and said the company could charge between $250 and $300 to simultaneously screen for cancers at multiple organ sites.

The launch was postponed last year when CombiMatrix restructured, shedding its research tools business to focus exclusively on diagnostics (BAN 5/11/2010).

"I don't think anything came of it," Jessup said of the CCA development program this week.


Have topics you'd like to see covered in BioArray News? Contact the editor at jpetrone [at] genomeweb [.] com.

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