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Cancer Genetics to Launch Two New Oncology-Focused CGH Array Tests by Year End

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CHICAGO — Cancer Genetics will later this year expand its menu of array-based tests to include assays for informing treatment of patients with diffuse large B-cell lymphoma and renal cell carcinoma.

Jane Houldsworth, the firm's vice president of R&D, said that CGI aims to obtain the appropriate licenses to offer the new tests as a service through its CLIA-compliant lab by the end of the year.

Houldsworth spoke with BioArray News during the Cancer Cytogenomics Microarray Consortium's annual meeting, held here this week.

CGI, based in Rutherford, NJ, currently offers two array-based tests as a service to clinicians. The tests rely on CGI's internally designed mature B-cell neoplasm, or MatBA array, to identify genomic aberrations with prognostic value in chronic lymphocytic leukemia and small lymphocytic lymphoma.

CGI's MatBA-CLL test received CLIA accreditation in 2010 and New York State licensure last year. In January, New York State issued a second license to permit CGI to test SLL samples. Agilent Technologies manufactures CGI's MatBA array on its 4x44K CGH platform, which allows CGI to run samples on four 44,000-marker arrays per slide.

According to Houldsworth, the new test for DLBCL will rely on the same MatBA array design, while the forthcoming assay for renal cell carcinoma will make use of a second internally designed array called UroGenRA.

The latter array is focused on kidney, bladder, and prostate cancers. For kidney cancer, the firm claims the array is designed to classify tumors at several levels of patient management: diagnosis of image-guided needle biopsies of small incidentally discovered kidney masses; diagnosis in patients with larger neoplasms to stratify for risks of local or regionally advanced disease; in those with metastatic disease, where drug trials are currently based on post-surgical tumor diagnosis; and, potentially, in the diagnosis of the so-called morphologically unclassified renal cancers.

According to Houldsworth, CGI offers its array-based tests within broader packages marketed to clinicians. The company also offers a number of other testing services, including sequencing, immunohistochemistry and fluorescense in situ hybridization, to its clients.

"We decided to set ourselves up as disease oriented, so we offer some specialty testing for some of these diseases, like CLL" said Houldsworth. In the case of CLL, CGI offers a package called CLL Complete that includes the MatBA-CLL test, as well as other assays, including FISH, karyotyping, TP53 and NOTCH1 gene mutation analysis, and IGHV rearrangement mutation status analysis. Houldsworth said that this inclusive approach enables the firm to offer its arrays to customers who may not be familiar with microarray technology.

"We often find that people who are sending us samples for [IGHV mutation analysis] are beginning to catch on and do the array as well," Houldsworth said. She added that CGI will likely offer packages for DLBCL and renal cell carcinoma in the same manner.

Some of CGI's customers do specifically request array analysis. Houldsworth said that academic institutions often mandate that internal labs perform certain tests, such as FISH analysis, and permit the outsourcing only of tests that they do not offer internally, such as CGI's array-based tests. CGI also enables customers to order individual tests during the treatment process, rather than running all tests offered within a particular package like CLL Complete.

In terms of competitors, Houldsworth portrayed most of the other cancer cytogenetic offerings on the market as being broader in scope. For CLL, she said that a number of for-profit and academic labs are running whole-genome arrays on CLL "because historically it is relatively calm in a genomic sense, and it is easier to study because it is peripheral blood."

Baylor College of Medicine, for instance, offers cancer chromosomal microarray analysis on a 400,000-marker array that targets 2,300 cancer-related genes. ARUP Laboratories also offers a Cytogenomic SNP Array for oncology testing. And PerkinElmer's Signature Genomics business provides cancer testing on its Human OncoChip. Yet while CLL is named as an indication for all arrays, the chips are not solely focused on that disease, Houldsworth noted.

"All of these cancers are treated in different ways," said Houldsworth. "DLBCL, for example, is an aggressive lymphoma and it has questions that need to be answered versus something like follicular lymphoma, which is a relatively indolent disease until it progresses to the point where it needs to be treated," she said. So, like its competitors, CGI is using an array format, but unlike some of them, it has opted for a targeted approach.

Wanting to Expand

Founded in Cambridge, Mass., in 1999, CGI initially focused on FISH and karyotype analysis. When it moved into its current 17,936-square-foot space in Rutherford in 2008, it opted to expand its services to include chromosomal microarray analysis.

"As a natural extension of looking at genomic aberrations in human cancer, we decided that the arrays would be a good field to go into, so when we moved to Rutherford, we bought the equipment we needed," Houldsworth said.

In addition to the MatBA and UroGenRA arrays, CGI has two others in development. The third array, called UgenRA, is focused on the gynecological cancers — cervical, ovarian, and endometrial. And a fourth, known as LeukA, is expected to aid in the differential diagnosis and prognosis of the main types and subtypes of leukemia. Houldsworth did not provide a timeline for when either could become available to clinicians. "They are all in different stages in our research lab," she said.

Last December, the privately held company filed a prospectus with the US Securities and Exchange Commission, and, according to an amended filing in May, it is seeking to raise up to $49 million in an initial public offering. According to Houldsworth, all of CGI's array-related business to date has been in the US, but it is hoping that the IPO proceeds will allow it to expand its sales and marketing efforts both in the US and abroad.

"I think the sales force needs to be expanded significantly," Houldsworth said, adding that winning new array customers requires the education of clinicians. She did not say how many CGI staffers are involved in sales and marketing. The company's current headcount is around 50. She added that CGI also plans to spend the IPO proceeds on R&D.

In its May SEC filing, CGI said that about $14 million of net proceeds would go toward expanding its business and funding current operations; $10 million would be used to hire additional sales and marketing personnel and to support increased sales and marketing activities; $9 million would be directed at repaying certain debt; and $9 million would be targeted for R&D work and scientific collaborations.

At the time, the firm said it planned to to trade under the ticker symbol "CGIX" on the Nasdaq Global Market. According to that filing, in 2011, Cancer Genetics recorded $3 million in revenues, up 20 percent from $2.5 million in 2010, while its net loss more than doubled to $19.9 million last year from $8.4 million in 2010.

For the first quarter of 2012, revenues rose 1 percent to $835,000 from $825,000 in the year-ago period, while its net loss improved to $1.1 million from $9.1 million.

CGI said that between its founding in April 1999 and March 31, 2012, it had accumulated a net loss of $43.3 million. As of the end of the first quarter 2012, it had cash and cash equivalents of $2 million.

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