Product expansion comes as UnitedHealthcare issues positive coverage decision on PGx testing, including Genomind’s service, for certain patients with major depressive disorder or anxiety
PGx Express provides the most comprehensive information available on the variants of an individual’s genetic profile known to impact mental health treatment
Industry-leading service with 99.9% laboratory accuracy and results within three days
Simplified resources and expanded consults will enable clinicians to better understand a patient’s genetic profile and the implications for mental health treatment
Enhanced services launched in response to recent FDA requests on mental health pharmacogenomic reporting
KING OF PRUSSIA, PA, August 5, 2019 – Genomind®, a leading mental health care company, is launching on August 10, 2019 Genomind Professional PGx Express™, a new, more focused report and set of services to enhance its mental health genetic test. Genomind Professional PGx Express will provide physicians with the most current, science-backed information and includes consultations upon request to help them navigate the connection between an individual patient’s genetic biomarkers and their implications for mental health treatment.
The Company opted to launch Genomind Professional PGx Express in response to positive clinician feedback, growing demand in the market, and recent FDA requests to laboratories performing pharmacogenomic (PGx) testing to remove any mentions of medications or drug classes from PGx reporting. Signaling the growing acceptance for PGx mental health testing, UnitedHealthcare has issued a positive coverage decision for the use of multi-gene panel PGx testing, including Genomind’s service, in certain patients being treated for major depressive disorder (MDD) or anxiety.
Genomind Professional PGx Express genetic test services will quickly provide the important information in a patient’s genetic profile. In addition, new technology and consultative services enable access to resources to help medical providers understand the implications of these genetic biomarkers. In analyzing 24 genes associated with mental health, Genomind Professional PGx Express provides the most comprehensive mental health genetic test results available.
“Our understanding of how genetics impacts disease and wellness continues to grow exponentially, particularly in the mental health space, which is ten years behind other diseases, such as cancer,” said Shawn Patrick O’Brien, Chief Executive Officer at Genomind, Inc. “We consider it essential that all mental health clinicians, including psychiatrists, primary care providers, and nurse practitioners, can obtain the most up-to-date scientific knowledge of patients’ genetics and how they can affect their mental health journey. Genomind Professional PGx Express will provide this complex but valuable information, which will help build the individual clinical picture and, ultimately, help physicians manage their patients. As the recent coverage decision from UnitedHealthcare shows, the demand for PGx guidance in mental health is growing fast among clinicians and patients and Genomind is well positioned to lead the way.”
Positive Coverage Decisions from UHC
In an August 2019 network bulletin, UnitedHealthcare issued a positive coverage decision for the use of multi-gene panel PGx testing, which would include Genomind Professional PGx Express, in certain patients. In removing Genomind’s test from the list of ‘not medically necessary PGx panels,’ the report indicates that the use of PGx testing is proven medically necessary when the patient has a diagnosis of major depressive disorder or anxiety and has failed at least one prior medication to treat their condition. In addition, UnitedHealthcare cited the cost savings demonstrated in several studies examining PGx-guided therapy versus treatment without, including the Perlis et al study using Genomind’s test. This study demonstrated that, compared to similar patients who did not use pharmacogenomic testing, patients using Genomind’s test demonstrated a $1,948 cost reduction in the first 6 months, 40% fewer emergency room visits for any cause, and 58% fewer hospitalizations for any cause.i Coverage will be effective October 1, 2019.
Expanded Insights and Technology to Enable Wider Access to Genetic Treatment Implications
To enhance its consult offering, Genomind is doubling its pharmacogenomic expert counseling resources. The Company will also soon add real-time chat capabilities to its clinician portal. The expanded suite of resources will also include:
- A new allele frequency chart, which serves as a basic genomic backgrounder listing the possible combination of alleles for each of the genetic variations in the report as well as the frequency of these variations in different ethnic populations;
- An Rx MetaType Card compatible with electronic medical records (EMRs) that provides the individual patient’s genotype and the expected impact (phenotype) for certain genetic variants related to drug metabolism. A patient’s ‘metatype’ can have a critical impact on the effects of drugs on that individual; and
- Access to NeuroFlow, a progressive collaborative care digital platform of behavioral health smart phone apps to help the care team and patients better track compliance with treatment plans and enable remote monitoring and measurement-based care.
Genomind’s ‘express’ reporting and consults will enable a broader range of practitioners involved in mental health – including primary care and OB/GYN providers – to use individual genetic profiles in making their treatment decisions.
“As the field of psychiatry moves more towards a biologically-based science, and as we learn more about the biological basis of psychiatric illnesses and their associated treatments, pharmacogenomics will continue to be an increasingly important additional tool for providers,” said Stephen M. Stahl, M.D., Ph.D., Adjunct Professor of Psychiatry at the University of California, San Diego, and a member of Genomind’s Scientific Advisory Board.
New Service Aligns with FDA Requests on Genetic Testing Reports
The FDA states on its website that pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and guiding drug dosing levels. There are more than 260 FDA-approved medications required to carry pharmacogenomic biomarker information on their labels, including more than 30 used in the treatment of mental health.
The expanded Genomind suite of services also comes in response to a recent FDA request to eliminate references to medications and medication classes on mental health pharmacogenomic reporting. The new format has also been restructured to provide context on genetic profiles and how they impact a patient’s journey.
“Genomind will continue to meet and partner with FDA to develop the path forward to communicate pharmacogenomic information to health care professionals, for the benefit of their patients with mental illness. That productive dialogue is ongoing as we collaborate on the best path forward to realize the benefit of pharmacogenomics,” continued Mr. O’Brien.
Improving the Industry’s Fastest Turnaround
Genomind will provide clinicians, as quickly as possible, with the essential genetic information that affects how patients may react to treatments. Genomind Professional PGx Express provides genetic test results to physicians within three days of Genomind’s in-house lab receiving the patient sample. Each sample is tested twice to provide 99.9% accuracy. 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.
About Genomind® Professional PGx Express™ (PGx Express)
Via a painless cheek swab administered in the physician’s office, Genomind Professional PGx Express collects information on 24 well-characterized, well-annotated genes, making it the most comprehensive mental health genetic test available. These genes are extensively supported in peer-reviewed publications to have an impact on treatment for psychiatric conditions. They include pharmacodynamic genes, which clinicians can evaluate to assess the effect a drug has on the body to help inform treatment selection. They also include pharmacokinetic genes, which clinicians can evaluate to assess how the drug is metabolized, which may have important implications for treatment.
Genomind Professional PGx Express supports the genetic profile implications for the treatment of mental health diseases including:
- Chronic pain
- Bipolar disorder
- Obsessive-compulsive disorder (OCD)
- Attention deficit hyperactivity disorder (ADHD)
- Post-traumatic stress disorder (PTSD)
- Substance abuse
Genomind is a leading mental health care company, delivering the genetic testing tools designed to empower clinicians to make better informed treatment decisions and create better outcomes for patients with mental illnesses. As the scientific leader in genetic testing, Genomind’s flagship offering is Genomind Professional PGx Express (formerly Genecept Assay)– the most comprehensive mental health genetic service available. Supported by a world-class genetics lab and unique consultative approach, Genomind is advancing a new paradigm of personalized medicine in mental health care. Learn more at www.genomind.com.
i. Perlis R et al. Pharmacogenetic testing among patients with mood and anxiety disorders is associated with decreased utilization and cost: A propensity‐score matched study. Depression and Anxiety, 2018. https://doi.org/10.1002/da.22742