NEW YORK (GenomeWeb) – Cancer Genetics intends to use its recent purchase of BioServe Biotechnologies India as an entry point to make its tests available to customers on the subcontinent.
Cancer Genetics CEO Panna Sharma told BioArray News this week that the Rutherford, NJ-based molecular diagnostics firm will begin selling its FISH-based FHACT test for cervical cancer in India later this year, followed by the launch of its microarray-based MatBA-DLBCL test for the for the prognosis of diffuse large B-cell lymphoma in the first half of 2015.
Cancer Genetics expects both tests to drive its growth in India, where molecular diagnostics firms are jockeying to serve a widening middle class of approximately 370 million people. In regards to the FHACT test, Sharma noted that cervical cancer is the number one killer of Indian women today. The company anticipates obtaining a CE-IVD mark for the test in Europe before introducing it in India soon, he said.
Sharma also stressed the need for MatBA-DLBCL. "There is nothing like it in the Indian market today," Sharma said of the microarray-based test. "Non-Hodgkins lymphoma is on the rise in India, and as the population ages and becomes more Western in diet and lifestyle, the rate of cancers is rising," he added.
Cancer Genetics will not pursue a CE-IVD mark for MatBA-DLBCL, but will offer the assay as a laboratory-developed test via BioServe's 14,000-square-foot genomics facility in Hyderabad. Sharma said that Cancer Genetics is working to make BioServe's lab CLIA-compliant prior to introducing its various tests there.
"To grow globally, we have to make sure we are under the same levels of accreditation in order to assure customers in India that they get the same quality of service, and to assure pharma and biotech clients that no matter where our test is done it is with the same rigor and robustness that we offer in the US," he said.
In June, Cancer Genetics acquired Gentris and its Chinese subsidiary for $4.8 million and Sharma said this week that the company has similar intentions to establish a CLIA-complaint facility in China.
"We are in both India and China now and we are trying to make sure all of the sites are all the same," he said. "That is one of the big things that biotech, pharma, and clinical customers want: harmonization."
Cancer Genetics paid $1.9 million to buy BioServe, gaining 33 employees in the arrangement. BioServe offers its 200 clients next-generation sequencing, genotyping, and DNA synthesis services, and Cancer Genetics said at the time the deal closed that it would recognize immediate revenue through BioServe's long-term contracts with academic and research institutions and its capabilities in genetic research, test development, and genomic analysis.
In addition to MAtBA-DLBCL, Cancer Genetics aims to introduce sequencing-based tests to the Indian market, Sharma said. He did not elaborate.
A more robust test
Founded in Cambridge, Mass., in 1999, Cancer Genetics initially focused on FISH and karyotype analysis. When it moved into its current space in Rutherford in 2008, it opted to expand its services to include chromosomal microarray analysis. It launched its MatBA-DLBCL test in 2013.
MatBA-DLBCL is an array comparative genomic hybridization-based assay that provides clinicians with prognostic values and information about risk progression of the disease. The test, which is both CLIA approved and New York State licensed, targets 15 distinct chromosomal regions, and relies on a microarray manufactured by Agilent Technologies.
Earlier this week, Cancer Genetics announced that it is working with Imran Siddiqi, a pathologist at the Keck School of Medicine at the University of Southern California, to identify and evaluate genomic markers for the prognosis of DLBCL.
According to Sharma, Siddiqi has been using the company's MatBA-DLBCL array as a research tool since the beginning of this year. He said that since the results reported back to clinicians rely on a smaller subset of data obtained from the array, the chip also serves as a discovery platform when all of the data generated is taken into account.
Currently, clinicians who order Cancer Genetics' MatBA-DLBCL test are provided with information as to whether a patient is at low or high risk of cancer recurrence. Working together with Siddiqi, the company now aims to discover changes that are linked to other potential risks, such as cell of origin data, and the anticipated timing of a relapse.
"These are the kinds of data not found in broad-range genomic panels," said Sharma. "These are very specific questions determined by very specific decision trees. This is what is really needed to drive the treatment paradigm."
Should Siddiqi and Cancer Genetics obtain clinical useful information from their study, the company will obtain additional CLIA and New York State clearances, Sharma noted. "We would like to be able to provide more than just black and white information on the chance of relapse," he said. "Just giving the relapse risk information is not enough, we would like to further expand that stratification," he added.
Cancer Genetics and Siddiqi recently completed another collaborative study on CD23+ diffuse nodal follicular lymphoma that relied on the MatBA array platform as the main research tool. Preliminary results of the effort will be reported in October at the Meeting of the European Association for Hematopathology in Istanbul, Sharma said.