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Newly Renamed MolecularHealth Rolls Out Drug Safety-Assessment Software

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By Uduak Grace Thomas

MolecularHealth, which recently changed its name from Life Biosystems, launched its first product this week: Molecular Analysis of Side Effects, or MASE, a software-as-a-service offering for use in drug safety assessment and prediction.

The company has also opened a new office in New York that will be headed by Jeffrey Marrazzo, the company's chief business officer. This new location adds to the company's operations in Basel, Switzerland; Heidelberg, Germany; and Houston, Texas.

Marrazzo told BioInform that the company chose a new name to reflect a new business direction, which is to help physicians, drug developers, and payors improve health by providing them with tools to make "safer and more effective treatment decisions."

"We view ourselves as a clinico-molecular informatics company," he said. "We believe that we are creating a new breed of informatics company where we are bringing together some of the techniques and technologies and power of bioinformatics with tools and techniques from the clinical informatics and decision support space."

To that end, the company plans to release two new solutions this year that will cater to drug safety and oncology markets.

The first of these, MASE, combines information from the US Food and Drug Administration's Adverse Event Reporting System with clinical and molecular information about drug activity in patients to help users analyze a drug’s safety profile from both molecular and statistical perspectives.

Last April, the computational oncology firm shared some initial results of its informatics-based approach to personalized medicine at the annual meeting of the American Association for Cancer Research in Orlando, Fla.

The company's researchers presented two posters, one of which described the in silico discovery and subsequent experimental validation of an alternative receptor for erythropoietin, or EPO, which is used to treat chemotherapy-induced anemia in cancer patients; and a second which outlined MASE (BI 4/15/2011).

The poster at AACR described a "potential approach to doing drug safety assessment that could be achieved by combining traditional observational-based approaches to safety science with a mechanism-based approach," Marrazzo said this week.

Since the conference, the company has worked on developing that approach into a solution — MASE — which it has now commercialized and intends to market to a number of "players" in the drug development industry, he said.

"Since the goal of our technologies are to inform safer, more effective treatment decisions, what will form a lot of our commercialization approach would be approaching those types of organizations within the drug development and prescription life cycle" including regulators, drug developers, and payors, he said.

According to MolecularHealth, MASE enables mechanism-based safety analysis for all drugs currently on the market, along with the identification of potential adverse events for drugs in development.

The tool includes methods to predict potentially causative molecular mechanisms; analyze adverse event data for drug, drug classes, targets, or pathways; compare safety analyses; define and analyze virtual patient cohorts; analyze the molecular profiles of individual patients; and incorporate results from clinical trial and adverse drug event management programs, the company said.

Specifically, it integrates curated and contextualized information for all marketed drugs, documenting adverse event cases as well as co-medicated drugs reported, and generates molecular views that highlight elements of the proteome disturbed through administration of these therapies.

It includes a set of analytical approaches that mine target combinations that are clinically beneficial, that increase the incidence of side effects, and that alleviate certain drug side effects. It also provides a strategy to predict novel targets of established drugs, based on side effect dissimilarities between structurally comparable agents.

Furthermore, MASE offers a set of analytical and visualization tools to help users detect and validate safety signals proactively instead of relying on "retrospective observational data," David Jackson, MolecularHealth's chief scientific officer, said in a statement.

This capability makes the tool amenable for use by the FDA, which is adopting mechanism-based approaches to assessing drug safety that will complement current approaches that are based on observing statistical signals in drug data, Marrazzo told BioInform.

He added that the company sees the FDA's focus on mechanism-based safety science as "a validation of our approach."

In addition to MASE, MolecularHealth plans to release a second tool in the first half of this year that will focus on molecular oncology.

The company intends to launch what it calls molecularly guided treatment decision support solutions for use in oncology that will structure and integrate molecular data — including whole genome sequences — with clinical information about patients, and translate these data into evidence-based treatment strategies for marketed and clinical stage therapies.

Marrazzo declined to provide further details about the upcoming molecular oncology offering.


Have topics you'd like to see covered in BioInform? Contact the editor at uthomas [at] genomeweb [.] com.

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