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Intervention Insights to Spend $7.2M Financing on Refining PGx Service, Proving Effectiveness

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This story has been updated to clarify the company's previous work with the Dana Farber Cancer Institute.

By Molika Ashford

Personalized medicine software company Intervention Insights has raised $7.2 million in Series B financing, which it plans to use to support commercial growth of its molecular drug-matching service, OncInsights.

The company will also use the funding to support comparative effectiveness and observational studies for the service.

Jerry Callahan, Intervention Insights' CEO, told PGx Reporter this week that OncInsights provides a searchable online report matching a patient's gene-expression profile to actionable therapies, independent of clinical features or disease.

The testing and reporting service is based on bioinformatics technology developed over the last decade at the Van Andel Research Institute. The company plans to market it to community oncologists for patients with advanced cancers.

"We started around work done at the VARI to develop a personalized medicine package where we could take tumor samples, do genomic assessment of those and then help align drug treatment information in support of a physician making whatever decision they want to make," said Callahan, who previously served as director of business development at VARI.

"This was based on work with research institutes, but we wanted to see, could we provide the same service in the community setting? And can we do it for community oncologists at a distance? Can I do it in Des Moines, Iowa, can I do it in Paducah, Kansas? So we created the company in 2009 to do exactly that."

The OncInsights service starts with genomic analysis of a patient's tumor sample taken during a biopsy. Using a kit the company provides, physicians send a small portion of the tumor sample to its CLIA-certified laboratory for analysis. According to Callahan, the company worked hard to establish this step of the process so that it could be adaptable enough to work in a variety of community settings.

"One of the groups we work with practices at 16 different hospital systems in the regional area," he said. "That’s 16 sets of pathologists, 16 sets of surgeons."

For large cancer centers, such as the Dana Farber Cancer Institute, maintaining the quality of a patient's sample isn't as problematic as when less specialized facilities are collecting the sample. "When we did work with Farber, we had a research nurse in the surgical suite that would take a piece of the sample," Callahan said. "We don't get that luxury from a distance."

The company then analyzes the tumor with an Affymetrix 133 2.0+ array, measuring "more than 20,000 genes and 54,000 molecular data points" to create what it calls a "full molecular pathway map" of the patient’s disease.

Intervention Insight's bioinformatics is the backbone of the company, and is based on a tool called XB Bio-Integration Suite, developed at the VARI and licensed by Intervention Insights for commercial use. It matches drugs to the genes and pathways identified in the patient's molecular profile as aberrant.

Callahan said a team of scientists curates drugs into the company's database, which currently includes hundreds of treatments. Each drug must meet certain criteria to be included, including having been identified in at least one, but in most cases two, clinically relevant, peer-reviewed studies in a human setting.

"We are in the process of adding mutations on top of the genomic analysis we do to try to further inform the drug knowledge for the doctor's consideration," Callahan said.

The end result is a digital physician's report that provides a list of drugs linked to the patient's molecular disease characteristics. Drugs are recommended in the OncInsight report purely based on molecular status, though backup information related to the patient's particular disease is provided for the doctor to use to inform treatment decisions.

"We start looking at the world from a molecular drug context, independent of looking at the clinical attributes. Then we overlay on top of that … the elements used to make that call – what's the literature evidence, what's the drug evidence … And further, what is the important information about the use of this drug in [the] patient's disease context," Callahan said.

According to Callahan, OncInsights is broadly applicable to the varying needs and resources of academic centers and community practices. "Obviously, when we work with academic centers — and we have several clinical trials going on right now with academic centers — they approach the information differently. They have the time and resources to explore the lines of evidence as such," he said.

Meanwhile, in the community setting, oncologists need patient data in a user friendly format, so they can quickly sift through the information and learn what is necessary to treat their patients. "We line all the molecular pieces around their individual patient … so in one 10-minute window, they can get the report and go as deep as they want to go on any line of evidence in the report to help them form a treatment plan for the patient," Callahan said.

"80 percent of all cancer patients live and die in the community setting, never make it into a research facility or onto a clinical trial. We want to be there."

Currently, OncInsight costs $3,950. Callahan says the test isn't covered by any insurance companies officially, but some have reimbursed for it after being billed.

Because OncInsight recommends drugs fairly agnostically and without regard to a patient's clinical diagnosis, the service tends to recommend treatments outside their labeled use. Callahan gave the example of a 58 year-old male patient with colorectal cancer. Based on the OncInsight report, he said, the man's doctor chose three drugs: Celebrex (an arthritis drug), Amiloride (a hypertensive drug), and Tykerb (a breast cancer drug.)

These kinds of motley pairings arise from the system's focus on matching drugs straight to the patient's molecular profile. In this case, anecdotal evidence suggested the patient had improved quality of life on this treatment combination.

Other services for molecular drug matching tend to take a more disease-targeted approach. For example, software firm CollabRx recently released a freely available Targeted Therapy Finder for Melanoma, based on curated pharmacogenomic data organized to create several distinct molecular subtypes of melanoma that are then linked to treatments (PGx Reporter 4/27/2011).

According to a recent overview in the Journal of the National Cancer Institute by Dan Hayes, a medical oncologist at the University of Michigan in Ann Arbor, Caris' Target Now is the market leader among such molecular therapy finders.

Callahan acknowledged that TargetNow provides coverage and molecular analysis that is similar to OncInsights, but said that it covers less than eight cancer types and 50 drugs.

OncInsights, meantime, distinguishes itself with a "full genomic screen… leveraging eight analytical methods," and considering 300 therapies that have been approved by the US Food and Drug Administration — far more than competing services. "Add to this that our service is not limited by cancer type, covering more than 200 cancer types, [and] we believe ours is leading the industry at this time," he said.

"Each patient's profile is 100 percent unique and provides typically different drugs in different ranks based on their molecular expression," Callahan added.

But while Intervention Insights can claim breadth in its analysis, it may lag somewhat in depth. Callahan said OncInsight reports do not rate drugs in cases where several different therapies might all be recommended for the same molecular pathway.

"Some drugs may be a better inhibitor of a target than another," he said. "We're not making that call at this point. In the future we're hoping to."

According to Callahan, OncInsight also offers greater speed from sample to result than other services. From the time Intervention Insights receives the patient's sample, the company aims to analyze the sample and return the report to the physician within five business days. A fast turnaround time, he noted, is critical for community oncology practices.

"Many other groups are taking weeks — several months even — for these late-stage cancer patients who need to get on the drug," Callahan said. "Our goal has always been to improve on that."

Intervention Insights has also had conversations with pharmaceutical companies about the possibility of using the OncInsight method to select patients for clinical trials for investigational drugs. Currently, the database behind the system only contains FDA approved drugs. Callahan said the company has incorporated experimental drugs in the context of research, but not in a commercial setting.

With the recently raised $7.2 million, Callahan said the company plans to work to build out research in three areas, first continuing retrospective analysis of stored samples to evaluate the service's accuracy in assigning treatment. Secondly, Intervention Insights hopes to continue its presence in observational trials. Callahan said OncInsights is being used in several trials, which the company is monitoring to find patterns and trends.

"Currently [we] have four observational trials underway including both pediatric and adult cancers," said Callahan, "one in support of the Neuroblastoma and Medulloblastoma Translational Research Consortium."

For the latter trial in medulloblastoma, Intervention Insights has been granted an investigational device exemption by the US Food and Drug Administration. An IDE is granted to sponsors when safety and effectiveness data is being collected for a test in order to support a premarket approval application or a 510(k) submission to the agency.

Separately, Intervention Insights is providing genomic analysis, sample logistics, and its CLIA lab and informatics services to the NMTRC trial, as well as a final report for each patient (PGx Reporter 6/1/2011).

"Another of our trials is an adult solid tumor study in refractory cancer patients and is being sponsored by a large payor" focused on personalized medicine, Callahan said. Although Callahan didn't identify the payor, he noted that the payor has agreed to pay for the study, as well as for the drugs used to treat patients in the study.

Lastly, he said, the company plans to use the funds to pay for an overall comparative effectiveness study for OncInsight.

The question remains whether OncInsight or other tests, such as Target Now, actually lead to better outcomes for patients and save money in treatment. Results from Intervention Insights' pilot study of its service were only published in abstract form, but the planned effectiveness study Callahan mentioned, as well as results from the NMTRC trial, should shed more light on the clinical utility of the service.

Callahan said that Intervention Insights is working to incorporate data from these various studies into the OncInsight service.

"We consent each patient for data to follow and track the oncologists' use of our services (i.e. the drugs they chose for their patient’s treatment) and the patient’s resulting performance [and] track the methods which are best performing to inform and improve our methods," he said in an e-mail to PGx Reporter.

"Our whole philosophy is we [may not] have it right today, but the information we are providing today is better than six months ago and it's nowhere near the information we're going to be providing six months and a year from now," Callahan noted. "We're not beholden to any platform or any algorithm or any methodology. We are absolutely betting on the collective knowledge of researchers, and aligning that information in as near real time as we can to a community of physicians."


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

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