Gaurav Singal was a successful computer scientist. The language of programming just clicked, he said. But there was a sense of purpose and meaning missing, so he headed off to medical school.
He is now vice president of data strategy and product development at Foundation Medicine, a company that was founded with that scientist-clinician mentality baked in. That’s important, Singal said, because it helps the team think about the practical application of what they do with genomics, diagnostics, and data.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
As everyone knows, these technologies don’t exist in a vacuum. The realities of healthcare too often get in the way and limit medical advances to patients at major academic institutions.
Thankfully, there’s a technology solution for expanding access too.
In a recent phone interview, Singal discussed how Foundation is overcoming precision healthcare barriers by connecting community cancer centers with tests and clinical trials. Also in the works: A universal companion diagnostic, which could help disrupt the field.
Singal will also be discussing the limitations of precision medicine on August 1, at the MedCity CONVERGE conference in Philadelphia.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Community cancer care
On May 23, FDA delivered a monumental ruling: It approved Merck’s checkpoint inhibitor Keytruda for a range of solid tumors. For the first time, the deciding factor was not what tissue the person’s cancer originated in; it was whether the cells expressed so-called mismatch repair genes.
It was a symbolic moment for precision medicine, but it also raised some questions about the reality of its application. For clinicians to identify the right patients, they need to have their tumors sequenced. This frequently doesn’t happen outside of the major academic centers.
Foundation is working hard to ensure its diagnostics make it to community cancer centers as a routine part of oncology care, Singal said. Of the 40,000 tests it ran last year, over half came from community centers.
But what good are the sequencing results if the patient doesn’t have access to the relevant drugs, many of which are in clinical trials?
“That’s another area that has traditionally be focused on major academic centers, where these clinical trials are run,” Singal said.
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To combat this, the company has launched Foundation SmartTrials, which helps pharma companies optimize their clinical trials. Part of Foundation’s job is to cast a wide net, to efficiently capture patients with the target mutations. It’s in everyone’s interests for the patients to be matched with the right precision medicine study, after all.
“Basically, it helps enable awareness and access. Especially for patients with rare genomic mutations, but not exclusively,” Singal explained. “That helps find clinical trial options that may be relevant for them, in concert with their histological and anatomical disease.”
One example the company cites is a trial that was looking for a rare fusion of a protein called ROS1. It occurs in around 1-2 percent of patients with non-small cell lung cancer (NSCLC). During the trial, a patient with this mutation was identified in a non-academic setting.
“One of our staff oncologists reached out to that provider to tell them about the availability of this clinical trial and its relevance for that particular finding,” Singal said. “The provider and patient consulted and decided that they wanted to try that route, but they didn’t have access to the trial because it wasn’t an academic center.”
Tapping into its partnership with a network of just-in-time sites, Foundation was able to get a new site activated to treat this individual. Within seven days of finding the mutation, the patient was screened, enrolled, and getting access to the drug at his local center.
“Which is an unheard of rate, especially for a non-academic site,” Singal added. “So that’s the kind of thing I think will be required for this medicine to be democratized.”
Universal companion diagnostics
Another potential tool for the disruption of cancer genomics is waiting in the wings. U.S. and European regulatory agencies are currently evaluating a universal companion diagnostic created by Foundation. (Thermo Fisher Scientific has a similar test –the Oncomine Universal Dx for NSCLC – also undergoing FDA review.)
Singal expects an approval to be a watershed moment for the field. It will bring a new level of rigor and scientific scrutiny, he said, noting that the tests are complicated and that lives are potentially at stake.
Perhaps more importantly, a universal companion diagnostic could totally recast the economic feasibility of genomic tests in cancer.
“The traditional model of one test for one drug is really hard to sustain when some of the things we’re looking for are really rare,” Singal explained.
Using the ROS1 example, 98-99 percent of patients would test negative for the mutation. Can payers and providers justify testing that many patients for one or two hits? On the flipside, how many different mutations do you test for in each and every individual? If someone is weakly positive for a druggable mutation, do you keep ordering and paying for tests?
A universal diagnostic could test for dozens of mutations in a single run, vastly increasing the actionability of each test and giving patients the best options – and perhaps more options – for treatment.
With these kinds of advances, precision medicine can hopefully become the standard-of-care throughout the United States and beyond.
Photo: Natali_Mis, Getty Images
