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Kew Group Enlists Cardinal Health to Promote CancerPlex NGS Test to Community Oncologists

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Originally published Oct. 7.

NEW YORK (GenomeWeb) – Genomic testing services firm Kew Group recently inked a deal with Cardinal Health Specialty Solutions to promote a next-generation sequencing-based testing service that it is hoping to sell to community oncologists looking to personalize treatment decisions for cancer patients.

Cardinal Health Specialty Solutions provides medical services and distributes drugs to community practices, payors, and pharmaceutical firms, aiming to streamline patient care, improve quality, and reduce costs. The specialty solutions group is under the aegis of Cardinal Health, which services more than 60,000 locations.

Cardinal Health Specialty Solutions itself serves around 100 community oncology practices in the US, a network into which it will spread the word about Kew's CancerPlex NGS testing service. Additionally, Cardinal Health's ties with drug developers could also help doctors direct patients to the right investigational drug trials with the help of Kew's test.

Cardinal Health decided to promote CancerPlex as part of its service offerings in part due to physician demand. "So many oncologists are asking Cardinal for tests that can guide therapy, that they decided to offer CancerPlex," Stephen Lyle, director of Kew's molecular diagnostics lab, told PGx Reporter.

Cardinal Health has also invested in Kew. The firm, along with the Boylston Street Group, participated in a private funding round for Cambridge, Mass.-based Kew in February. In a filing with the US Security and Exchange Commission in February, Kew reported that same month that it had raised $16.1 million toward a $30.1 million goal. The company hasn't had another financing round since February.

Kew launched CancerPlex a year ago. The NGS-based test analyzes more than 400 cancer genes for abnormalities that are associated with patients' variable responses to cancer drugs. According to Lyle, CancerPlex gauges genetic markers associated with response to the 50 or so targeted cancer drugs approved by the US Food and Drug Administration, as well as to drugs in clinical development.

Although genetic testing panels such as CancerPlex have become commonly used tools at large cancer centers and academic care facilities, the majority of cancer patients, around 80 percent, are treated at community practices without access to such tools. Of the projected 1.6 million new cases of cancer likely to occur in the US next year, "only [approximately] 20 percent of these patients will be seen at large academic medical centers like those in Boston," Lyle pointed out. Kew's mission is to reach the majority of community providers with CancerPlex.

When a doctor orders CancerPlex, Kew will ascertain the patient's tumor sample from the pathologists, analyze the sample for genomic markers in a CLIA-certified lab, and return the report to the oncologist within 10 business days. Kew chose to launch a large NGS-based panel instead of a single-marker test in order to cost-effectively capture rare markers and avoid having to run multiple tests on a small amount of tumor tissue.

"CancerPlex genes were selected because of their importance in tumor biology. Analyzing more genes increases the chance of discovering actionable findings that lead to more choices for treatment," Lyle told PGx Reporter. Although the test gauges numerous genetic markers, the report that the doctor will see will highlight the drugs that a patient might benefit from or drugs in clinical trials that the patient could enroll in.

The list price for the test is $5,500, in line with other marketed NGS-based cancer panel tests. For example, Foundation Medicine's FoundationOne carries a list price of $5,800. Lyle said Kew has received payment from private payors for performing the test and is waiting for Medicare to establish its payment policies for further clarity on test payment.

On the regulatory front there is also uncertainty. The FDA recently released draft guidances on its oversight plan for lab-developed tests, a subset of diagnostics that CancerPlex falls under. Under the plan, the regulatory requirements that labs will have to meet will be in line with the risk their tests pose to patient health. The agency has indicated that it considers tests used to make prescribing decisions about drugs (i.e. pharmacogenetic tests or companion diagnostics) to be high-risk devices.

"Kew Group currently operates a CLIA-approved molecular diagnostics lab," Lyle said. "It is unclear what action the FDA may take, but we expect to obtain any approval [or] clearance necessary to provide this critical information to patients and their oncologists."

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