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Molecular Health Steps Up Marketing for Tumor Profiling, Treatment Decision Software


NEW YORK (GenomeWeb) — Molecular Health is starting to market its TreatmentMap tumor profiling and treatment decision support software more widely as it prepares to test the product's benefits in clinical studies.

The software helps analyze and interpret genomic data from a patient's tumor to identify suitable treatments, while avoiding toxic ones. "It's really about helping physicians identify the drug that's going to work and avoid the use of drugs which are going to cause problems," said David Jackson, the company's chief innovation officer.

Founded in 2004 as a clinical research IT firm, Molecular Health has about 125 employees and plans to grow to approximately 200 by the end of this year. The company, which has shifted its focus to informatics-driven diagnostics, is headquartered in Heidelberg, Germany, and has a CLIA-certified laboratory in The Woodlands, Texas. It also has an office in Boston and plans to open another one in California later this year.

Funding for the firm comes from Dievini Hopp BioTech, an investment firm that was founded by former SAP CEO Dietmar Hopp. Friedrich von Bohlen, former Lion Bioscience CEO and current managing director of Dievini, chairs Molecular Health's board of directors.

The company's TreatmentMap decision support software is registered as a medical device in Europe and Molecular Health offers it through partners in the European market, either to analyze tumor exome sequencing or tumor panel sequencing data. Earlier this year, the company struck a sales and marketing agreement for TreatmentMap with sequencing service provider GATC Biotech, and Jackson said it also works with genetic diagnostics firm CeGaT in Tübingen.

In the US, Molecular Health has been offering TreatmentMap as part of a laboratory-developed test, a 613-gene next-gen sequencing panel performed in its Texas laboratory, which became CLIA-certified last year and has processed several thousand samples so far.

However, the company is now starting to market the TreatmentMap software on its own in the US as well, both as a service and for on-site installment. "We're in the early stages of market launch, and the interest levels are exciting," Jackson said, adding that its target customers are diagnostic laboratories and large hospitals.

Last month, for example, Molecular Health teamed up with the Guardian Research Network, which will use TreatmentMap, along with two other Molecular Health products — InsightMap and OutcomesMap — to identify cancer patients for clinical trials and other applications.

TreatmentMap looks both at somatic and germline-derived mutations in a tumor sample. It incorporates features of another technology developed by the firm, called SafetyMap, which is used by pharma firms and government agencies, including the US Food and Drug Administration, to detect and better understand adverse drug events. 

According to Jackson, TreatmentMap is unique in that its reports include information on both drugs that are predicted to work well and drugs a patient is unlikely to respond to, or may show adverse events to. "Now the challenge is to prove the clinical utility advantage of that combination," he said.

To that end, TreatmentMap will be used as part of a clinical trial at the National Center for Tumor Diseases in Heidelberg that will start enrolling more than 1,000 patients later this year. In addition, Molecular Health is planning a separate study with an unnamed US collaborator that will focus on the drug safety component of the software.  

Last month, the company presented results from a pilot study at the Worldwide Innovative Networking (WIN) Symposium in Paris that tested its treatment prediction approach.

For that study, researchers used data from 250 patients representing 20 different cancer types, generated by the company's Texas laboratory using the 630-gene NGS panel. Mutations found in the tumors were screened against more than 5,500 known predictive biomarkers.

According to the conference abstract, they found predictive mutations, or biomarkers, in almost 90 percent of tumors. About a quarter of them had FDA-endorsed biomarkers, 70 percent had biomarkers previously observed in the clinic, and 72 percent had translational biomarkers that are supported by preclinical or computational data.

Notably, in many tumors, the scientists found germline-derived mutations that predict drug toxicity. Those mutations modified treatment recommendations because they pointed to toxicity issues with targeted drugs or with chemotherapy agents that are often given in combination with targeted drugs.

"Our results confirm that somatic mutation profiling is essential but not sufficient for predicting cancer drug response, thereby supporting the need for diagnostic analysis of both germline and tumor biomarker information," the researchers concluded.