Genomind said it has resumed including information about medications in its reports on pharmacogenomic tests, a month after removing it—but only in versions of the reports that are sent to physicians.
Patient reports will continue to omit the information on specific medication names and classes, furnishing gene-only information instead, the company recently told physicians. The original removal came in response to the FDA’s nearly year-long crackdown on laboratory developed tests (LDTs) and other pharmacogenomics (PGx) tests that reference specific drugs or drug classes, unless approved by the agency.
Restoration of the medication info came about after the company began working closely with the FDA to address agency concerns, CEO Shawn Patrick O’Brien said in a statement to Clinical OMICs
“While the company waits for clarity from the FDA, Genomind will keep medications off reports that are made available to patients,” O’Brien stated. “Genomind is committed to engaging the FDA in an ongoing dialogue as it determines the best path forward for patients.”
At deadline the FDA had acknowledged, but had yet to respond to, questions from Clinical OMICs about Genomind’s action or its dialogue with the company.
O’Brien spoke nearly a week after Genomind announced plans to present abstracts at two upcoming scientific conferences showing how Genomind’s pharmacogenomic test was used toward directing mental health pharmacotherapy.
At Psych Congress 2019, to be held October 3-6 in San Diego, Genomind plans to present results in which participants saw significant clinical improvement in depression and quality of life over a 14-week trial. Genomind said results from the study, titled “Medication Optimization Using Pharmacogenomic Testing and a Drug Interaction Guide in a Complex Mental Health Population,” suggested that the medication changes based on the company’s PGx assay results were beneficial, particularly in a medically complex patient population prescribed psychiatric polypharmacy.
Genomind said its presentations followed earlier independent studies, one of which showed that the use of the company’s test improved patient outcomes and reduced costs by almost $2,000 in the six months following testing. Genomind was among several companies whose pharmacogenomic tests were cited by United HealthCare in concluding, in a policy statement effective October 1, that “The use of pharmacogenetic multi-gene panels to guide therapy decisions is proven and medically necessary for antidepressants and antipsychotics medication” when all of three criteria are met:
- The individual has a diagnosis of major depressive disorder or anxiety.
- The individual has failed at least one prior medication to treat their condition.
- The multi-gene panel has no more than 15 relevant genes.
40% Fewer ER Visits
A 2017 study citing Genomind’s Genocept pharmacogenetic 10-gene test found that patients who had PGx testing had 40% fewer emergency room visit for any cause and 58% fewer hospitalizations for any cause.
“The service provides genetic test results to physicians within three days of Genomind’s in-house lab receiving the patient sample, with each sample tested twice to provide 99.9% accuracy,” O’Brien further stated. “Genomind’s lab has the highest level of accreditations, meeting Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and New York State Department of Health standards.”
The FDA’s enforcement initiative began with a “Safety Communication” that warned patients and healthcare providers not to change patient medication regimens based on results from genetic tests claiming to predict a patient’s response to specific medications, but which are not supported by scientific or clinical evidence.
The FDA followed up by contacting companies that offer PGx tests, demanding that they revise their test reports and labeling, or withdraw such tests. “Most firms addressed the FDA’s concerns by removing specific medication names from patient test reports and informational material,” the ACLA noted.
When one test developer, Inova Genomics Laboratory, declined to follow suit, according to the ACLA, the FDA accused Inova in a “Warning Letter” of “illegally” marketing genetic tests that had not been reviewed by the agency for safety and effectiveness. Initially, Inova noted that it had been offering MediMap tests under what it termed “FDA’s policy of enforcement discretion for [LDTs], as previously described in the FDA’s publicly available statements and documents.” But in April, Inova ended MediMap testing.
In recent weeks, two industry stakeholder groups have weighed in on the FDA crackdown. The American Clinical Laboratory Association (ACLA) last week urged the FDA to halt its enforcement initiative, and instead encourage “responsible” LDT development by adopting recommendations such as those offered by professional groups, and formally recognizing existing peer-reviewed, evidence-based guidelines as a basis for establishing clinical validity of a PGx test.
Earlier this month, The Association for Molecular Pathology (AMP) published a position statement for pharmacogenomic testing that spells out “best practices” criteria for laboratories to follow. AMP’s statement included criteria that are designed to ensure responsible use of the tests, while preserving broad access and improving patient care, according to AMP.
