The Woodlands, Texas based MolecularHealth has announced the official launch of TreatmentMAP, its cancer treatment decision support offering that became commercially available in Europe and the U.S. in April.
With TreatmentMAP, the company has the technology to provide doctors and patients with faster, more accurate insights into the role genes play in the progression and treatment of an individual patient’s cancer by using advanced proprietary tumor analysis and interpretation to match patient-specific genetic and molecular test findings to the current state of the world’s biomedical knowledge about cancer diseases.
Based on a proprietary analytics engine more than eight years in development by a multidisciplinary team of doctors, scientists and IT experts, MolecularHealth’s TreatmentMAP leverages results of next-generation sequencing (NGS) genetic tests to identify the most efficient and safest cancer treatment options for each individual patient, thereby providing cancer patients and their medical teams with information to guide in the selection of targeted cancer treatments, all presented in a clear and understandable way.
With TreatmentMAP Targeted Panel, MolecularHealth claims to have compiled the largest gene panel commercially available today, with over 500 genes that cover several thousand variants that have been determined to have the most clinical impact in cancer, and are therefore most likely to make a difference in treatment outcome.
TreatmentMAP Whole Exome is the first commercially available whole exome analysis for cancer, enabling clinicians to take a comprehensive look at a patient’s genetic profile by examining genes of both the tumor and patient.
Both of these testing options incorporate MolecularHealth’s SafetyMAP, a proprietary identifier of drug target safety or resistance effects, which uses the FDA’s Adverse Event Reporting Systems (AERS) as an input for analysis. MolecularHealth says that thanks to its negotiated five-year research collaboration agreement with the FDA, it is able to incorporate key data from AERS into SafetyMAP, thereby providing the first drug safety analysis that combines adverse event information with molecular knowledge about drug activity within a patient. This helps ensure that treatment options will not only be effective, but won’t have unintended negative consequences for patients.
“I believe that the future of medicine lies in our ability to interpret seemingly disparate information,” says Lloyd Everson, M.D., co-CEO of MolecularHealth. “With the technology now at our disposal, there are mountains of data constantly being churned out of labs and clinical trials — but until recently, it was an unwieldy task to do anything productive with that information. TreatmentMAP allows us to pull in all of that data and make it truly usable.”
TreatmentMAP tests can be ordered in the United States and in Europe. In the U.S., a patient’s oncologist or pathologist sends a tumor sample to MolecularHealth’s CLIA-certified NGS lab in The Woodlands. Once the sample is sequenced, data on the tumor’s DNA, along with additional medical information on the patient, is fed into the company’s automated analytics platform. This platform cross-references patient-specific data with the latest peer-reviewed evidence, clinical trials, and other sources. A simple-to-understand report is delivered to the patient’s medical team, highlighting the treatment options that are most likely to be both effective and safe.
“We are still trying to understand cancer, and as an oncologist I have observed that the most effective cancer therapies are those that precisely target the unique biology of an individual patient’s tumor,” says Joyce O’Shaughnessy, M.D. , co-chair of breast cancer research at US Oncology and Baylor-Sammons Cancer Center. “TreatmentMAP offers new insights into the molecular drivers of a tumor, leading to expanded therapeutic options and greater chance for therapy response.”
“As a pathologist, I’m happy to have a company joining the molecular diagnostic space that’s more pathologist-friendly than some of the competition in this field,” says
Thomas Wheeler, M.D., chairman of the Department of Pathology & Immunology at Baylor College of Medicine. “The market can only benefit from having more options to meet the needs of individual patients, and from what I’ve seen, MolecularHealth’s reports are not only more robust, but focus on the elements that are most important when determining a treatment path for a patient.”
Drs. O’Shaughnessy and Wheeler are members of the MolecularHealth advisory board.
MolecularHealth was founded in 2004 in Basel, Switzerland, with a research arm in Heidelberg, Germany. The founders had an ambitious goal: To improve patients’ lives by using advanced information technologies to understand the role that genetics and other molecular changes play in both illness and treatment.
Since 2004, MolecularHealth has played a key role as a software analysis provider for the Human Genome Project and has established itself as a clinical IT development partner for leading U.S. health and hospital systems and as an innovator in biomarker discovery and drug safety science. This gives it a unique perspective on genetic analysis and its application in the clinical setting.
In 2007, MolecularHealth discovered a novel safety biomarker for cancer patients being treated with erythropoiesis-stimulating agents, and entered into a 10-year agreement with the University of Texas MD Anderson Cancer Center at Houston. In 2012, the company launched its next-generation drug safety assessment solution Molecular Analysis of Side Effects (MASE), and inked a five-year agreement with the U.S. Food and Drug Administration (FDA), as well as entering into an agreement with SAP to shape the future of personalized cancer treatment.
That same year, MolecularHealth scientists and technologists began work to develop a proprietary knowledge-modeling platform that can analyze and synthesize vast amounts of molecular, biomedical, and clinical evidence to provide precise, personalized treatment options for cancer patients.
The company’s collaboration with organizations such as The MD Anderson Cancer Center and the FDA have been a proving ground for its pioneering use of advanced information technology to understand the role genetics play in cancer and the impact that genes have on treatment effectiveness and drug safety.
In 2013, Molecular Health established U.S. corporate offices and a next-generation sequencing facility at The Woodlands, Texas.
The company notes that genes are the language of life, but understanding that language is made difficult by the volume of information generated by today’s advances in molecular and gene-based testing and the velocity of medical research. Molecular and gene-based testing grows less expensive with each passing year, but interpreting test results still takes a considerable resource of people working manually for weeks and months MolecularHealth is committed to translating the genetics language into actionable information that doctors and their patients can use to make informed decisions about cancer care, supporting the best and safest treatment options for each patient.
Scientists have known for years that cancer is caused by genetic changes to a person’s cells. But it was only relatively recently that it was realized that these genetic changes were different from person to person. Not only were there genetic differences between specific types of tumors, there were also differences between patients with the same type of tumors. Because of this, cancer treatments often worked well for some patients but not at all for others. Even though these patients share the same diagnosis, because of their genetics, only some of them will respond to a particular therapy. For a few patients, the therapy will even be toxic.
Now we know that genetic alterations in cancer cells control not only the onset and progression of the disease but also the effectiveness of the treatment. But there are hundreds if not thousands of things that could go wrong genetically to cause cancer, and only a small fraction of them are known at the moment.
MolecularHealth says 75 percent of cancer treatments don’t work. Only a small percentage of patients are likely to respond to any particular cancer treatment because every patient’s cancer is different — unique to their own genetic makeup.
However, until now, doctors have lacked any way of predicting which drugs would work for which patients. Instead, they start by using treatments that are accepted as working for most patients, moving to more specialized treatments only if the patient fails to respond.
MolecularHealth helps doctors determine up front which treatments might be most effective before treatment even begins, noting that information is critical to choosing the best possible cancer care, since medicine is just beginning to understand that where a cancer starts — lungs, breast, colon — is less important than the subtle genetic changes that cause it to start and drives its progression.
Unfortunately, gene-based and molecular testing generates an avalanche of data, which can take clinicians weeks to translate and then cross-reference with medical literature in order to prescribe the safest, most effective therapy for an individual’s cancer treatment.
MolecularHealth uses proprietary, advanced computer techniques to filter through this data in a fraction of the time needed for current manual analysis, pinpointing the most relevant findings and recommendations, so the patient and his/her doctors can make informed decision about treatment — delivering on the promise of personalized, precision medicine.
The collaboration with reading research institutes and the FDA has led to several breakthroughs. Together with MD Anderson, for example, Molecular Health identified a biomarker that can predict and classify bladder cancer in patients, just based on a single blood sample.
Today, the company is ready to make its genetic and molecular analytics technology available to the broader medical community, so that any doctor in any setting can provide patients with personalized, precise cancer treatments. Understanding the specific genetic and molecular profile of a patient’s tumor enables doctors to better tailor the exact treatment needed for the best results.
What Makes MolecularHealth Different
MolecularHealth says that while its labs are equipped with the latest in next generation sequencing (NGS) equipment, they are much more than testing laboratories. Testing labs only identify a specific set of findings, and, if a result falls outside of that narrow set, they might not recognize it as significant. On the other hand, MolecularHealth’s solutions are built around cutting-edge capabilities in biomedical information technologies. Its scientists look broadly, using the company’s knowledge base to analyze tumors mechanistically, finding things others might miss.
However results from MolecularHealth’s next-generation sequencing lab are just one type of information they use in their analysis — along with clinical metrics, the outcomes of other patients with similar types of cancer and (when available) the patient’s current and historical medications history. These data points are incorporated into the following analysis modules:
- Genomic analysis prioritizes the best anti-cancer drugs, based on the genetic determinants discovered from DNA cancer sequencing.
- Pharmaco analysis optimizes treatment based on what is known about what prescription drugs the patient is taking today and how they might interact with other possible treatments. Even over-the-counter medicines and herbal supplements can have a tremendous impact on a cancer treatment’s safety and effectiveness.
- Clinical metrics use retrospective evidence from clinical outcome databases, leveraging the experiences of other doctors and other patients in guiding courses of treatment.
All this information serves as input for MolecularHealth’s proprietary clinical rules engine, which then delivers a result report for the physician, along with an opportunity for a patient’s health care team to do advanced exploration into the database to more fully understand the findings and the treatment options.
MolecularHealth’s whole exome sequencing analysis takes a comprehensive look at a patients’ genetic profile and offers great breadth of analysis against modern medical information and knowledge. Moreover, it also provides insights into findings that might show promise in the near future.
Whole exome testing fully characterizes the functionally important areas of the human genome — that is, those areas that are translated into proteins for use by the cell. While the whole exome constitutes around 1 percent of the total human genome, a large majority of disease-causing mutations are to be found in the exome.
MolecularHealth has the tools to understand the complete mechanism behind a patient’s cancer. They are not solely looking at tumor biomarkers, which is largely the current state of available genetic cancer testing services. Instead, they look at the genes of both tumor and gene line (the body’s natural, starting genes).
It’s not only about what genetic factors in the tumor that the drug is interacting with from a mechanistic perspective, but it’s also about how the body as a whole is capable of metabolizing the drug. MolecularHealth looks at mutations in both sets of genes — cancerous and normal — to understand both the pharmacokinetic and pharmacodynamic effects.
MolecularHealth is headquartered in Heidelberg, Germany. U.S. headquarters, including a CLIA-certified NGS lab, is located in The Woodlands, Texas. The company also has offices in Boston, Mass.
Baylor College of Medicine