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MolecularHealth Readies NGS-based Oncology Assays

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MolecularHealth is in the final stages of validating a targeted sequencing panel and an exome sequencing test for cancer patients and plans to launch the tests within the next couple of months, the company told Clinical Sequencing News at last week's Molecular Medicine Tri Conference in San Francisco. The company is also planning to develop a test for blood-based cancers.

Shelly Gunn, the firm's chief medical officer, told CSN that the company is developing a gene panel, dubbed TreatmentMap, that will contain more than 500 genes involved in tumorigenesis or linked to pathways with clinical utility. Additionally, it also plans to launch TreatmentMap Whole Exome. Both assays will run on the Illumina HiSeq 2500 in the firm's CLIA-certified laboratory in The Woodlands, Texas.

Under a recent agreement, GATC Biotech will provide laboratory information management systems in MolecularHealth's clinical laboratory.

In addition, GATC Biotech has been providing expertise in automation and robotics to "develop the lab for scalability," Gunn said, which will be crucial as the company adds more testing capacity. She added that GATC Biotech also helped validate the test.

MolecularHealth was originally founded in Basel, Switzerland and its headquarters are now in Germany, so when it established its next-gen sequencing laboratory in The Woodlands, "GATC Biotech was a natural partner," Gunn said.

Turnaround time for the panel test will be around 10 days, with the exome test taking around four weeks, Gunn said. However, she noted that the lab has also done exomes in around one week, so she said that it would be able to reduce turnaround time if necessary.

As the company previously said, it has developed automated software that can generate a clinical report in one day.

Included with the TreatmentMap test will also be what MolecularHealth calls SafetyMap, where the company analyzes the matched normal sample for germline pharmacogenomic variants that could influence adverse drug-related events and potential drug-drug interactions, Gunn said.

Gunn anticipates that clinicians will order the exome test primarily as a reflex assay in cases where the targeted panel fails to identify actionable mutations. Exome sequencing is "more expensive and the coverage is not as deep, so I see most of our patients having a panel first, and if that is negative, perhaps reflex to the exome test."

There will be some patients for whom going straight to an exome test will make sense, she said, but that will be a small percentage.

The company has not yet set a price for its test, but Gunn said it will be comparable to other targeted cancer tests on the market, such as Foundation Medicine's FoundationOne test. Foundation has not specified what it charges for its test, but said that during the third quarter of 2013, average reimbursement was $3,300 per test.

In cases where MolecularHealth samples both tumor and normal tissue, patients will have the option of receiving information regarding incidental findings in their germline DNA. However that will not be provided as a default, Gunn said. "What will be reported is specific to the tumor."

Moving forward, she said that company is working on developing a similar sequencing-based test for blood-based cancers. Additionally, she said that it is considering moving into noninvasive testing of circulating tumor cells "in the not too distant future."

While the company has thus far focused on oncology, Gunn added that moving beyond cancer is not out of the question.

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