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GenomeDx Launches Program to Combine Clinical, Genomic Data for Prostate, Urological Cancers

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NEW YORK (GenomeWeb) – This week, GenomeDx Biosciences launched the Decipher Genomics Resource Information Database (Decipher GRID), a clinical genomics data sharing program that aims to combine the information in cancer centers' patient registries with GenomeDx's database of genomic information for prostate and bladder cancers.

Through the program, the company intends to collect more than a million data points from each patient, and will "analyze and leverage those data to ask questions that can ultimately lead to a better understanding of how we manage and treat these patients at every critical decision point," Doug Dolginow, CEO of GenomeDx, said in a statement.

"This program has the potential to create new information that will completely redefine our understanding of the biology of prostate and other urologic cancers," Dolginow added.

The Sidney Kimmel Center at Thomas Jefferson University is the first institution to partner with GenomeDx to access the program. Dolginow told GenomeWeb that the company expects at least four more medical centers to join the program by the end of the year. The company is not disclosing the names of the partner centers at this time.

GenomeDx offers an RNA expression-based test for prostate cancer — the Decipher Prostate Cancer Classifier — that assays 22 validated biomarkers to predict cancer aggressiveness. The test is used to identify patients at high risk of metastatic disease or prostate-related death a few years post surgery. Earlier this year, the company announced that national Medicare benefit administration contractor Palmetto GBA had issued a positive coverage policy for the test. In February, GenomeDx researchers and their collaborators published a study that showed that the test can distinguish between prostate cancer patients at high and low risk for metastasis post surgery and could potentially predict which patients would benefit from follow up radiotherapy. In total, the company has published 14 peer-reviewed publications on Decipher, according to Dolginow.

To participate in the GenomeDx program, cancer centers need to have clinical oncology programs approved by an Institutional Review Board with protocols in place for obtaining informed consent from patients. Sites that don't have in house IRBs can set up external bodies to review their programs. GenomeDx also has in house medical directors who will screen and vet centers prior to acceptance into the Grid program.

Initially, the program will focus on collecting data from men with prostate cancer with plans to eventually expand into other urologic cancers, GenomeDx said. Eligible participants will receive Decipher testing, GenomeDx said, and all the genomic data collected from them will be anonymized and stored in a HIPAA-compliant cloud infrastructure from Amazon Web Services where it will be accessible to researchers at participating cancer centers. These researchers will continue to follow the patients in the study and track their treatments and outcomes.

GenomeDx has an internally developed bioinformatics pipeline that it uses to evaluate and analyze biomarker data collected from its Decipher test and to identify the best biomarkers for stratifying patient populations for studies and treatments. It will make some of the components of that pipeline available to researchers who sign up for Decipher Grid access, Dolginow said. They'll have access to the genomic information collected during testing and will be able to use the company's algorithms to mine the information, compare aggressive and non-aggressive forms of prostate cancer, and to identify new biomarkers that could lead to more efficacious treatment options for patients as well as stratify patients for possible clinical trials and research studies, he said.

Furthermore, since the program is expected to collect data from potentially large numbers of patients and since the data will be contained in a single resource, it could eventually be used to systematically study urological cancers at a population level, Dolginow noted. "With this large genomic resource, we can look across populations now which is very helpful because you can start to see how cohorts of patients and populations respond or don't respond to treatment," he said.

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