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Molecular Health Shutters NGS Lab, Commercializes Underlying Software Solutions

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NEW YORK (GenomeWeb) – Molecular Health has retired the wet laboratory component of its business and is now focusing on selling software solutions for clinical decision support, GenomeWeb has learned.

Earlier this month, the company released the Molecular Health Guide Workbench Manager and the Molecular Health Guide Clinical Annotation Service. These are two new products for oncologists and pathologists that are based on the company's cloud-based Dataome technology. The company officially launched the solutions at the Association for Molecular Pathology meeting, which was held earlier this month in North Carolina.

These products use many of the same capabilities that were included in a series of proprietary software products that Molecular Health used as part of a broader next-generation sequencing-based oncology testing service.

The lab's informatics infrastructure included a comprehensive biomedical data warehouse called Engineus, which formed the core of the software products used as part of testing. It is designed to integrate information on protein-protein interactions, cancer indications, clinical trials, drugs, and scientific literature from multiple sources. It supported products such as EngineusProfile+, a targeted gene panel and accompanying software, called EngineusGuide, that was used to provide cancer diagnostic testing and treatment decision support services to US-based clinicians.

However, Molecular Health Chief Medical Officer and US CEO Les Paul told GenomeWeb that the company decided to decommission the Houston, Texas-based wet lab earlier this year. The lab will officially close its doors in December this year. It also decided to discontinue the EngineusProfile+ product.

"We decided to discontinue the lab process because our strength is not in the lab," Friedrich von Bohlen, Molecular Health founder and executive chairman, said. "It's actually in database systems, content, and software, and in cleaning and curation — everything around the integration and contextualization of data [from] structured and unstructured [sources]."

The company is now focusing on commercializing the underlying bioinformatics products that it used in its lab for managing pipelines and reporting test results. It has now rebranded the Engineus knowledgebase as Dataome and uses that resource to support the updated products in its portfolio. Dataome is a resource for capturing and integrating molecular and clinical information including outcomes data from patients, curated variants from peer-reviewed biomedical literature, and drug safety information. Dataome incorporates the data and features that were available in Engineus but is more comprehensive than its ancestor, according to Molecular Health. For example, "We've added a lot more capabilities around data capture, knowledge mining, and analytics," Paul said. It also includes highly-curated clinical interpretations, something which was not available in the previous iteration of the resource.

Dataome now supports the company's Workbench Manager solution and the Clinical Annotation service, which grew out of what used to be EngineusGuide, von Bohlen said. For its part, the Workbench Manager offers tools for managing molecular pathologists' bioinformatics pipelines and workflows for analyzing NGS data from tumor samples through to generating custom reports. Among other features, the solution offers full traceability for workflows as well as a customizable report template for listing mutations and annotations, summarizing potentially effective and ineffective treatment options as well as treatments that may pose a higher risk of adverse reactions, and matching patients to potential clinical trials.

According to the company, the Workbench Manager is an end-to-end solution for smaller laboratories that are looking to begin offering NGS services and need help setting up their bioinformatics pipelines. It is designed to help these labs transform raw sequence files of Bam files to processed variant calls and apply curated content from Dataome to their samples to create custom reports that help oncologists looking to establish treatment plans for patients, Tom Strilko, Molecular Health's senior vice president of sales and business development, told GenomeWeb.

Molecular Health also offers the variant annotation portion of its Workbench solution as a distinct product called the Clinical Annotation service solution. The offering, which also is powered by Dataome, helps high-throughput laboratories provide clinical interpretations and annotations for actionable variants found in tumor samples including variant narratives, treatment options, matching clinical trials, and drug-drug interactions among other information. The software also features an interactive tool that lets users filter variants based on their needs and requirements, a feature which was not available in the EngineusGuide offering, von Bohlen said. 

Strilko explained that the company chose to launch a targeted solution for annotation to cater to large commercial and national labs that already have established and validated their bioinformatics workflows for sequence alignment through to variant calling, but who may need help with the clinical annotation component. These labs may not "have the expertise to go into depths to understand the clinical significance of all the variants that they identify," Gabriel Bien-Willner, Molecular Health's executive director for medical affairs, told GenomeWeb. "The clinical annotation service provides all that groundwork to explain the validity and value of potential treatment options" or can point out drugs that physicians would want to potentially avoid in clinical trials, he noted.

But the solution could also appeal to academic medical centers and regional reference laboratories that have some annotations based on internal datasets but are interested in annotations from third-party providers who have tested more samples from more cancers, Strilko added.

Molecular Health is offering its products under a tiered pricing model that operates on a cost-per-case basis, Strilko said. Specifically, for the clinical annotation service, pricing starts at $300 per case and then drops based on volume. Pricing for the Workbench Manager will also be on a per-case basis and will start at $250 per case. "Most of these are targeted panels," Paul said, and at this point, "we are not getting a lot of requests for whole-exome [or] whole-genome [panels]."

Workbench customers will also be charged an initial implementation fee that will cover set up, training, and support for the first year of use — that implementation fee starts at $25,000 per year. In subsequent years, customers will be charged an annual subscription fee that will cover the costs of ongoing support, modifications, and customizations to their systems, and maintenance. Workbench customers could also pay for a separate development license to access and query the Dataome content directly to, for example, generate new hypotheses for further study. Molecular Health currently has some customers in its pipeline who are interested in both products, but it is not disclosing who these are at the present time.

"The strength of our product is the automation and the scalability, and the ability to deliver high-quality content in a very timely manner," Strilko told GenomeWeb. "We believe that we can build our commercialization strategy around a tiered pricing effect based on that volume that will still be very competitive in the market and give access to both those early entry players into the space ... as well as those high-volume commercial laboratories."

Paul also believes that the comprehensiveness of Molecular Health's platform will make it attractive to potential customers. For example, there are other companies in the space that offer annotation software and services "but they may not have that sophisticated backend to link to and all the text data-mining, and all the natural language processing, and all the sophisticated algorithms that we bring to the market," he said. 

"We are providing high-quality ... context-specific clinical annotations for the variants ... based on market demand and the potential customers we've dealt with and that are in our pipeline," Bien-Willner added. "We use [our] technology and algorithms and processes to capture and create that content ... which is also reviewed by scientists, medical curators, and then physicians. That's a lot of effort."

Meanwhile, the company continues to develop EngineusEffect. That software, which was previously called SafetyMap, is used for analyzing drug-induced adverse events and for predicting possible safety issues of new drug candidates. Von Bohlen said that the software is currently being tested as part of an early-access program with unnamed pharmaceutical companies, and it is working on acquiring additional content for the solution. It is not clear at this point when the company will release that solution, though, von Bohlen said.

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