NEW YORK (360Dx) – With the recent formation of the Get the Medications Right (GTMRx) Institute, Quest Diagnostics and the other institute co-founders aim to drive the use of advanced diagnostics for guiding patient treatment.
Launched this month by organizations including J&J, Medecision, and the American College of Clinical Pharmacy, the institute will function "as an advocacy entity" for companion diagnostics and pharmacogenomic testing, said Steve Goldberg, vice president, medical affairs, population health and chief health officer, health and wellness at Quest, and a member of the GTMRx board.
"We have the view that for companion diagnostics and pharmacogenomics, the time is right to have those capabilities brought into the diagnosis and treatment of patients," he said. "And I think this organization is going to create opportunities for us to collaborate to help accelerate that occurring."
Goldberg cited factors including the increasing availability of genetic analysis, the move towards more targeted therapies, and developments in artificial intelligence and machine learning as laying the groundwork for increased uptake of companion diagnostics and PGx testing.
He said that in addition to advocating for the use of such tests, the GTMRx could help facilitate collaborations among industry players to prove out the case for these tests.
"We're talking about a range of pilot [projects] where we could offer the testing in large populations and be able to look at the clinical outcomes and costs outcomes and help contribute to the literature on the impact of bringing these insights into diagnosis and treatment," Goldberg said.
He added that he envisioned the organization as potentially advocating for improved reimbursement "around companion diagnostics and pharmacogenomics as we accumulate additional data."
Goldberg said that the organization's exact priorities and mission will likely come into clearer focus after it holds its first board meeting next month, at which time he said it will likely begin working up a strategic plan.
Quest currently offers a PGx test panel that provides information on 44 genes that it says can help guide the use of over 280 drugs. According to the company, the panel "is based on pertinent literature sources that may provide clinical insights to help inform treating physicians about a patient's genetic attributes to help optimize patient treatment considerations and outcomes."
The company, Goldberg said, sees "great growth opportunity in both companion diagnostics and pharmacogenomics."
The regulatory environment for PGx testing has become somewhat muddied in recent months, however, as the US Food and Drug Administration has pushed back on what it said were instances of firms selling PGx tests whose claims are not well supported by existing scientific evidence.
In November, the FDA issued a safety letter warning medical providers and patients against changing treatments based on PGx tests that it has not approved for marketing and that are poorly supported by scientific or clinical evidence. It also said that it was investigating firms marketing unapproved PGx tests and that it might act against these companies.
On April 4, FDA sent a warning letter to Inova Genomics Laboratory asserting that the company was illegally selling its MediMap PGx tests without FDA approval, a move that has raised concerns within the industry about the FDA's intentions regarding regulation of PGx tests and laboratory-developed tests more generally.
Inova has stopped offering its MediMap tests while it prepares a response to the agency.
In an addendum to the press release announcing the November safety letter, FDA said that following release of the safety letter it "reached out to several firms marketing pharmacogenetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication's effects has not been established."
According to the agency, "most firms addressed the FDA’s concerns by removing specific medication names from their labeling, including promotional material and patient test reports."
Asked about the recent FDA actions and their potential impact on PGx testing, Goldberg said that "the way we [at Quest] take those occurrences is to really make sure that the attributions that we make and the insights we generate are evidence-based and can truly impact diagnosis and treatment. We are committed to being very thoughtful and science-driven as we advance our product portfolio."