Cancer Genetics this week said that its microarray-based test for diagnosing and monitoring diffuse large B-cell lymphoma has been deemed by regulatory authorities to be compliant with the US Clinical Laboratory Improvement Amendments as well as New York State regulations.
The clearances enable the Rutherford, NJ-based company to add the test to the menu of array-based assays it currently offers to clinicians. Cancer Genetics, or CGI, already offers clinical assays for chronic lymphocytic leukemia and small lymphocytic leukemia (BAN 8/7/2012 ).
Marie-Agnès Patrone-Michellod, CGI's manager of regulatory affairs and marketing, told BioArray News this week that gaining CLIA and New York State approval for the assay was "essential," not only so that it could offer the test in a commercial clinical setting, but also for reimbursement consideration by Medicare and other third-party payers.
All of CGI's diagnostics are based on its mature B-cell neoplasm comparative genomic hybridization array, or MatBA, platform. Agilent Technologies manufactures MatBA on its 4x44K CGH platform, which allows CGI to run samples on four 44,000-marker arrays per slide.
In a statement, CGI said that MatBA-DLBCL addresses a "strong clinical need" for disease diagnosis and monitoring, in order to inform treatment plans for patients. The disease is the most common form of non-Hodgkin lymphoma, accounting for roughly 40 percent of all cases, Cancer Genetics said. The US National Cancer Institute estimates that about 70,000 people will be diagnosed with non-Hodgkin lymphomas this year, and that nearly 20,000 will die of these hematological malignancies.
Patrone-Michellod said that based on a company estimate of 190,000 DLBCL patients in the US who need monitoring twice a year, and the addition of about 24,000 new patients annually, the firm believes the potential market size for the MatBA-DLBCL test to be between $700 million and $950 million annually. CGI's array provides clinicians with information on genomic alterations in DLBCL, "including regions of gain and loss that are associated with disease outcome," the firm claimed.
CGI and Memorial Sloan-Kettering Cancer Center have used the array to evaluate 87 patient samples, as well as two open datasets — one with 171 samples and another with 51. The company said that the collaboration resulted in the findings that MatBA-DLBCL "has both diagnostic and prognostic value," "can assist in patient stratification for risk-adapted therapy when performed at diagnosis," and can be used to "assess the presence of single biomarkers as well as genome complexity as measures of overall survival following front-line immunochemotherapy."
The firm also believes itself to be the only laboratory to have a CLIA- and New York State-approved microarray for the genomic assessment of DLBCL. The array-based assay is part of a DLBCL Complete program offered by CGI, which includes a suite of esoteric tests used in the diagnosis, prognosis, and clinical management of DLBCL patients.
CGI offers similar programs for CLL and SLL. As Jane Houldsworth, the firm's vice president of R&D, told BioArray News last year, these Complete offerings allow the firm to introduce its MatBA tests to customers who have requested other kinds of tests that rely on sequencing, immunohistochemistry, or fluorescence in situ hybridization, and are unfamiliar with array technology (BAN 8/7/2012 ).
"We often find that people who are sending us samples for analysis are beginning to catch on and do the array as well," Houldsworth said at the time.
Patrone-Michellod said that CGI is currently validating two other MatBA-based tests for clinical use: one for mantle cell lymphoma and one for follicular lymphoma. The company expects MatBA-MCL to be available in its clinical lab by the middle of this year. Both arrays have received "significant interest by the biopharma community for incorporation into clinical trials and companion diagnostics," she said.
Cancer Genetics is currently waiting to complete its initial public offering. Two weeks ago, it lowered the expected proceeds from the offering to $23.5 million. Patrone-Michellod declined to comment on the status of the IPO, but said the firm is currently updating its registration to include year-end audited numbers and other operational information on the company.