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Caris Launches Cancer Registry to Provide Outcomes Data on Clinical Utility of Molecular Profiling

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By Turna Ray

Caris Life Sciences is launching a cancer registry hoping to inform payors and healthcare providers about how oncology treatments administered based on patients' molecular profiles impact their outcomes.

The pathology and molecular testing services firm this week announced the launch of the Caris Registry, a biomarker-driven real-time data repository that doctors can use to help them gauge how patients will respond to certain chemotherapies, immunotherapies, and biological therapies.

The registry will contain information about patients using Caris' Target Now suite of molecular profiling services, including the genetic profile of patients' tumors, their cancer treatment history, and their clinical outcome.

Participation in the registry is voluntary for patients. Before enrolling a patient into the registry, the physician must make an independent decision to use Caris' Target Now molecular profiling tests.

"Caris anticipates that the Registry will provide vital information to the government, insurers, and medical providers by providing a high volume of real-time, catalogued outcome information for analysis," the company said in a statement. The company "also anticipates that collaboration with these organizations will result in the advancement of key drug-development strategies, future healthcare policies, prospective clinically relevant research trials, publications, and posters."

Along with impacting oncology treatment practices and driving payor acceptance, Caris is hoping researchers will use the data in the registry to conduct prospective and retrospective studies; evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatment; as well as identify patients for future studies.

Adoption of genomically driven personalized medicine products has been hindered by the lack of data on the impact of such interventions on patient outcomes. Payors often demand data from multiple, large, randomized clinical trials as evidence that pharmacogenomic tests improve patient outcomes before considering reimbursing for such tests.

The Centers for Medicare & Medicaid Services' Medicare Coverage and Evidence Development Advisory Committee in January reviewed the available evidence for five pharmacogenomic cancer tests and deemed only three to be clinically useful, including molecular tests to guide treatment with Herceptin for breast cancer, Gleevec in chronic myelogenous leukemia, and Vectibix and Erbitux in colorectal cancer patients. MEDCAC, however, identified numerous evidence gaps that CMS and private payors would require before covering such PGx cancer tests broadly [see PGx Reporter 02-03-2010].

Although Caris has no specific collaborations with payors regarding the registry at this time, insurers will certainly be paying attention to the type of outcomes data collected through the resource. "As the data in the registry matures, payors are invited to collaborate with Caris," Alan Wright, senior VP of strategy at Caris Life Sciences, told Pharmacogenomics Reporter this week.

Caris' Target Now tests are currently available nationally for making treatment decisions for patients with refractory and aggressive cancers. Patients can be tested by Target Now Complete, which helps guide treatment by analyzing the molecular and genetic changes in solid tumors such as lung cancer, breast cancer, and prostate cancer. Caris also markets Target Now Colon for molecular profiling in colorectal cancer. The company also plans to launch Target Now Breast, which will inform breast cancer patients about their tumors and treatment options.

Physicians will enter patient information into the registry using a web-based case report system that includes a query documentation trail, Wright explained. Caris notes on its website that the company is currently in the process of enrolling eligible practices for participation in the registry.

Caris will train clinical research coordinators in doctors' practices who are providing Target Now molecular profiling to their cancer patients. The quality of the data collected will be overseen by a certified registrar employed by Caris.

The company aims to collect case histories for at least 1,000 patients this year, which represents a portion of current Target Now customers. Caris' website notes that patient data collection processes will "be consistent with applicable laws, rules or guidelines on patient privacy, informed consent, data security, and human subject studies."

"If Target Now is used more frequently then we will have more opportunity to enroll," Wright said. "Ultimately, our intent is to grow the registry much larger overtime."

In order for patients to participate, they will need to be 18 years or older, be diagnosed with cancer, be eligible for Target Now Complete, and have surgical resection of their tumor analyzed by microarray, immunohistochemistry, or fluorescent in situ hybridization.

"The objective of the registry is to provide a community-based data source to further the evolution of molecular oncology and systems medicine," Wright said. The company aims to collect detailed information so that "analysis of the data can make original contributions to the body of academic evidence regarding the associations of genetic markers and the response to commonly used cancer treatments."

Furthermore, the Caris Registry will comply with the National Cancer Institutes' caBIG, or Cancer Biomedical Informatics Grid, which will allow the company to share the patient outcomes derived through the Target Now program with researchers, physicians, and patients in the cancer community.

"The intention is to make the data available to all members of the larger research community to further the treatment of cancer patients," Wright said.

"Registries are less expensive than prospective trials and cover more topics than post hoc analysis of previous clinical trials," Wright added. "High-quality registry information can make a significant contribution in identifying new associations in molecular oncology and the novel use of chemotherapy in treating cancer."

Similar to the Caris Registry, there are several efforts underway to electronically amass large databases of pharmacogenomics information, which researchers are hoping will drive further adoption of personalized healthcare.

For instance, Vanderbilt University in January launched the Vanderbilt Electronic System for Pharmacogenomic Assessment, or VESPA, to identify clinically validated gene variants linked to drug response and generate a list of important variants intended to aid healthcare providers in recognizing PGx opportunities in the care of their patients [see PGx Reporter 01-27-2010].

Pharmacy-benefits providers, Medco and CVS Caremark, are also tracking clinical outcomes associated with certain pharmacogenomic tests [see PGx Reporter 12-23-2009].

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