In recognition of Mental Health Awareness Month this May, Genemarkers, a CLIA-certified, CAP-accredited precision medicine laboratory, is calling attention to the growing role of pharmacogenomic (PGx) testing in reshaping mental healthcare. By analyzing how a person’s unique genetic makeup affects their response to medications, PGx testing helps to reduce trial-and-error prescribing, improve medication safety, and support better mental health outcomes by assisting patients to find the right treatments faster. 

Mental health conditions, such as depression, anxiety, and bipolar disorder, often require highly individualized medication management, with treatment responses varying widely from person to person. Research shows that up to 40% of patients with depression do not respond well to their initial antidepressant. As many as two-thirds may need to try multiple medications before finding an effective therapy (1). This process can stretch out for months, during which symptoms may persist or worsen, leading to a higher risk of hospitalization, functional decline, and, in severe cases, self-harm or suicide. 

Pharmacogenomic (PGx) testing offers a breakthrough approach to mental health treatment. By identifying genetic markers influencing how a patient’s body metabolizes and responds to medications, PGx testing empowers providers to personalize treatment plans, leading to faster symptom relief, fewer adverse drug events, and better medication adherence. 

“Too often, patients face a long and painful journey to finding the right mental health medication,” said Dr. Anna Langerveld, President & CEO of Genemarkers, “Pharmacogenomic testing allows healthcare providers to tailor treatment choices from the start, helping patients to find effective relief, faster.”

Beyond clinical improvements, PGx testing can also significantly reduce healthcare costs. A 2022 study found that primary care providers using PGx testing saved patients and payers an average of $3,398, while psychiatrists saved $1,308 per patient (2). Another study reported a 40% decrease in emergency department visits and a 58% decrease in hospitalizations when using PGx testing to guide treatment (3). 

“PGx testing doesn’t replace a provider’s expertise or clinical judgment, it enhances it,” added Langerveld. “It empowers healthcare providers with the actionable insights they need to make smarter, safer, and more effective prescribing decisions.”

This Mental Health Awareness Month, Genemarkers urges clinicians, caregivers, healthcare organizations, and patient advocates to explore how PGx testing can help transform the mental healthcare landscape – leading to faster recoveries and safer treatments. 

About Genemarkers

Genemarkers is a CLIA-certified, CAP-accredited genomics laboratory specializing in pharmacogenomic testing. Genemarkers partners with healthcare providers, pharmacies, health systems, and employer groups to deliver high-quality PGx testing to improve medication outcomes, increase patient safety, and reduce healthcare costs. Genemarkers’ PsychPainMarkers PGx Panel tests 3 genes associated with the safety and efficacy of 76 psychotropic medications, helping patients find the right treatments faster.

Sources:

1. Xu, L., Li, L., Wang, Q., Pan, B., Zheng, L., & Lin, Z. (2024). Effect of pharmacogenomic testing on the clinical treatment of patients with depressive disorder: A randomized clinical trial. Journal of Affective Disorders, 359, 117–124. https://doi.org/10.1016/j.jad.2024.05.063 
2. Lisa, B. C., Lorenz, R. A., Li, J., & Dechairo, B. M. (2017). Economic Utility: Combinatorial Pharmacogenomics and Medication Cost Savings for Mental Health Care in a Primary Care Setting. Clinical Therapeutics, 39(3), 592–602. 
3. Perlis RH, Mehta R, Edwards AM, Tiwari A, Imbens GW. Pharmacogenetic testing among patients with mood and anxiety disorders is associated with decreased utilization and cost: A propensity-score matched study. Depress Anxiety. 2018 Oct;35(10):946-952. doi: 10.1002/da.22742. Epub 2018 May 7. PMID: 29734486.

Genemarkers has developed ex vivo tissue models that mimic key components of atopic dermatitis (AD) and psoriasis to facilitate research of topical compounds for preclinical and clinical drug development. Our scientific team has verified the expression of over 30 AD-specific and 400 psoriasis-specific gene expression biomarkers in the tissue models.

Our stimulated ex vivo tissue models are ideal for performing studies investigating the efficacy of therapeutic compounds. Study endpoints may include: RNA sequencing to assess global changes in gene expression, targeted qPCR, ELISA methods for protein expression analysis, and immunohistochemistry.

Key Features:

• Biomarkers are supported by peer-reviewed, published literature
• Flexible study design options & reproducible results
• Ideal for screening compounds and determining efficacy

Genemarkers’ Dr. Anna Langerveld joined BerryDunn’s Robyn Hoffmann and Regina Alexander on the Healthcare Compliance Insights Podcast. During the episode, they discuss revenue integrity and how to foster a culture of compliance in independent laboratories.

“Compliance is embedded in the culture and mission of Genemarkers. Our entire value proposition is based on quality, integrity, and compassion. Compliance is a big component of quality and integrity,” says Dr. Langerveld.

To learn how Genemarkers creates a culture of compliance, listen to the episode, Compliance and Revenue Integrity for Independent Laboratories.

CPESN® USA announces the expansion of their strategic relationship with Genemarkers, LLC, a pharmacogenomic (PGx) testing laboratory in Michigan. Through this national program, CPESN pharmacies identify patients that would benefit from PGx testing, collect patient DNA samples via a buccal swab, and review the results with their patient and the healthcare provider. This personalized medicine tool determines if a medication will be safe and efficacious. PGx testing has been proven to reduce adverse drug events and improve health outcomes.

“We are excited to be moving forward with the team from Genemarkers,” said Alison Haas, Pharm.D., Director of Value-Based Programs with CPESN USA. “They have been working collaboratively with our pharmacies in their home state of Michigan for the past year. Now, we are launching a similar program across the rest of our local networks.”

CPESN USA is a clinically integrated, nationwide organization of over 8,500 pharmacist providers working in over 3,500 local, community pharmacies. CPESN pharmacies reach 84% of America through hand delivery to the doorstep of patient’s homes.

Genemarkers’ PGx tests include only drug-gene pairs with the highest levels of clinical validity and utility. Genemarkers’ PGx tests include drug-gene pairs that the Food and Drug Administration (FDA) and the Clinical Pharmacogenomics Implementation Consortium (CPIC) have recognized as having scientific evidence to support clinical use. Genemarkers currently offers three multigene PGx panels and two single-gene tests.

“We feel that pharmacogenomics testing has the ability to help a lot of patients in terms of optimizing medication use and ultimately improving health outcomes,” said Dr. Anna Langerveld, Founder and CEO of Genemarkers. “We have always felt that local, clinical pharmacists were ideally suited to play a significant role in this initiative, and we are excited to collaborate with CPESN pharmacies across the country.”

“I’m pleased Genemarkers has given local, community pharmacies the opportunity to get into the pharmacogenomics game,” said Troy Trygstad, Pharm.D., MBA, Ph.D., Executive Director with CPESN USA. “Pharmacists have been sitting it out for far too long.”

About CPESN® USA

CPESN USA a clinically integrated, nationwide organization of pharmacy networks structured to advance community-based pharmacy practice. They empower community-based pharmacies that are deeply rooted within their community by fostering their ability to provide high quality, patient-centered enhanced services. CPESN pharmacies integrate with other healthcare providers on the patient’s care team to coordinate medical treatment. The results are better medication adherence, higher patient satisfaction, and lower healthcare costs. You can find CPESN Networks of pharmacy providers in 43 states across America.

To learn more, please visit http://www.CPESN.com.

About Genemarkers, LLC

Genemarkers is a CAP-accredited, CLIA-certified, CLEP-approved genomics laboratory based in Kalamazoo that partners with healthcare providers and organizations to offer comprehensive, quality-driven pharmacogenomic (PGx) testing services. Genemarkers offers three multigene PGx panels and two single-gene tests that contain clinical guidance based on the highest level of evidence, as determined by the Clinical Pharmacogenomics Implementation Consortium (CPIC) and the FDA.

For more information, visit http://www.genemarkersllc.com.

Genemakers’ Clinical Testing Specialist, Stephanie Wheeler, was interviewed by Thermo Fisher Scientific to discuss pharmacogenomic (PGx) testing, its benefits, and how to implement a PGx testing program.

Using Thermo Fisher Scientific’s state-of-the-art real-time qPCR technologies, Genemarkers offers high-quality PGx testing services rooted in clinical validity/utility.

“From the beginning, we have performed our PGx testing using qPCR due to the flexibility and efficient workflow for processing the samples. The format allows us to customize the genes and variants that we analyze and test multiple samples at the same time,” says Wheeler.

Our tests follow guidelines set by the Food and Drug Administration (FDA), Clinical Pharmacogenomics Implementation Consortium (CPIC), and other regulatory bodies that determine clinical utility and validity based on scientific evidence. Currently, Genemarkers offers three multigene PGx panels and two single gene tests to meet the diverse needs of our clients.

Adverse drug events (ADEs) are the 4th leading cause of death in the United States, leading to 1.3 million emergency department visits and 350,000 hospitalizations annually.¹ Each year, 4.5 million ADEs occur in the US, resulting in $2.5 billion in related healthcare costs.^2-4 As many as half of ADEs are considered preventable, yet they continue to pose a serious public health risk with significant financial consequences. As the need to prevent ADEs becomes more dire, there is increased interest in minimizing patient risks.

Healthcare providers often turn to laboratory testing to manage their patients’ medications safely and effectively. For example, a physician might order a test to monitor serum potassium levels for patients taking angiotensin-converting enzyme (ACE) inhibitors or a liver function test (LFT) for a patient on statins.

Pharmacogenomic (PGx) testing is one under-utilized clinical tool that can significantly decrease a patient’s risk of experiencing an ADE. PGx testing identifies genetic variations that affect the structure and function of biological proteins associated with a medication’s absorption, distribution, metabolism, and excretion (ADME). Changes in these proteins functions can affect whether specific drugs are safe and effective for an individual.

PGx testing allows healthcare providers to personalize drug therapy and predict if a medication will be safe, effective, and non-toxic for a patient. Patients with personalized drug therapy based on PGx testing had a 30% lower occurrence of ADEs⁵ and 6.3% fewer hospitalizations.⁶ Additionally, PGx testing reduced emergency department and outpatient visits by 11% and 32.5%, respectively.⁶

About Genemarkers

Genemarkers is a CAP-accredited, CLIA-Certified, genomics laboratory based in Kalamazoo that partners with health care providers and organizations to offer comprehensive, quality-driven pharmacogenomic (PGx) testing services. Genemarkers offers three multigene PGx panels and two single-gene tests that contain clinical guidance based on the highest level of evidence, as determined by the Clinical Pharmacogenomics Implementation Consortium (CPIC) and the FDA.

Learn more

References

1. Nebeker JR, Barach P, Samore MH. Annals of Internal Medicine. 2004; 140:795-801.
2. Preventable Adverse Drug Reactions: A Focus on Drug Interactions. www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm110632.htm
3. Interventions to Improve Adherence to Self-administered Medications for Chronic Diseases in the United States: A Systematic Review. Viswanathan M, PhD; Golin C, et al. Annals of Int Med. 4 December 2012
4. US Department of HHS, Agency for Healthcare Research and Quality, Publication #01-0020; CDC Medication Safety Basics
5. Swen et al. Lancet. Vol 401. 2023
6. Brixner D, Biltaji E, Bress A, et al. The effect of pharmacogenetic profiling with a clinical decision support tool on healthcare resource utilization and estimated costs in the elderly exposed to polypharmacy. J Med Econ. 2016;19(3):213-228. doi:10.3111/13696998.2015.1110160.

Genemarkers LLC is pleased to announce it has been recognized as one of the Top 10 Pharmacogenomic (PGx) Service Providers of 2023 by Pharma Tech Outlook.

Pharma Tech Outlook is a leading industry publication bringing together insight from senior leaders in Pharma and Life Sciences. Each year, Pharma Tech Outlook recognizes the top PGx service providers. Genemarkers is honored to accept this accolade. 

As a pioneer in PGx testing, Genemarkers is a trusted partner for healthcare professionals and organizations interested in offering PGx testing services. PGx testing identifies genetic variations affecting the structure and function of biological proteins associated with a drug’s absorption, distribution, metabolism, and excretion (ADME). Changes in these proteins’ functions can affect whether specific drugs are safe and effective for an individual. 

“Our goal is to improve a patient’s medication management through comprehensive, quality-driven genomics services,” says Dr. Anna Langerveld, founder and CEO of Genemarkers “Our approach has always been rooted in our company’s core values: quality, integrity, and compassion. We believe in PGx and believe if used properly, it can have a significant impact on the patients’ health and quality of life.”

Genemarkers’ PGx tests include only drug-gene pairs with the highest levels of clinical validity and utility. Genemarkers’ PGx tests include drug-gene pairs that the Food and Drug Administration (FDA) and the Clinical Pharmacogenomics Implementation Consortium (CPIC) have recognized as having scientific evidence to support clinical use. Genemarkers currently offers three multigene PGx panels and two single-gene tests. 

What are ADEs and Polypharmacy?

An adverse drug event, or ADE, occurs when a person is harmed due to a prescription medication. This can include known medication side effects or medication errors. About half of ADEs are considered preventable, yet they continue to pose a significant public health risk with substantial financial consequences. Approximately 1.3 million emergency visits¹, 350,000 hospitalizations¹, and $3.5 billion in excess medical costs² occur annually in the United States from ADEs. The risk for ADEs increases with each medication a patient is taking, so patients taking multiple medications are at the highest risk for ADEs.

Polypharmacy occurs when a patient simultaneously takes multiple medications to treat one or more conditions. Nearly one third of adults in the United States take five or more medications³. Polypharmacy has become a significant concern in the healthcare industry, as it increases the risk for ADEs and medication failure. In extreme cases, polypharmacy can lead to death. As a result, strategies for decreasing polypharmacy and ADEs are a major focus of patients and healthcare professionals. This article will discuss how Pharmacogenomics (PGX) serves as a tool to help alleviate ADEs.

Who’s at risk?

Patients who are at the highest risk for polypharmacy include those with multiple health conditions, patients with more than one prescriber, and the elderly. In some cases, single conditions have guidelines which state that polypharmacy is a recommended treatment plan after monotherapy fails or underperforms. These conditions include hypertension, type II diabetes, and major depressive disorder. For these conditions, treatment guidelines instruct healthcare providers to add additional medications to a patient’s treatment plan when the first is inadequate. In some cases, healthcare providers may prescribe additional medications to treat the side effects of another drug. For example, a provider may prescribe an anti-nausea medication for a patient who experiences nausea as a side effect of codeine.

PGx – A Tool to Reduce ADEs and Polypharmacy

Laboratory testing is one of the most frequently used clinical tools to help providers safely and effectively manage their patients’ medications. Research shows that optimal usage of laboratory tests can decrease a patient’s risk of experiencing an ADE⁴. For example, a physician might order a test to monitor serum potassium levels for patients taking angiotensin-converting enzyme (ACE) inhibitors or a liver function test (LFT) for a patient on statins.

Pharmacogenomics (PGx) testing is one less frequently used clinical tool that can significantly decrease the risk of ADEs. PGx testing identifies variants in a patient’s DNA that affect how well that person responds to specific medications. PGx can help predict if a drug will be safe, effective, and non-toxic for a patient. The PGx test reduces the need for trial-and-error prescribing. Preemptive PGx testing is especially beneficial because it assists a prescriber in identifying a patient’s risk of experiencing an ADE before the medication is prescribed.

With PGx testing, a prescriber can make informed decisions that decrease the risk of polypharmacy. When a provider knows that a patient is more likely to have side effects from a medication, they can prescribe an alternative. Doing so eliminates the need for additional medications to treat the side effects of the first. A provider can also use PGx information to select a drug that is more likely to be effective for the patient. This reduces the risk of medication failure and makes it less likely that the provider will need to prescribe a second medication to treat the patient’s condition.

References

1. Centers for Disease Control and Prevention. (2017). Adverse Drug Events in Adults. Retrieved from https://www.cdc.gov/medicationsafety/adult_adversedrugevents.html. Accessed January 06, 2023.
2. Institute of Medicine. (2007). Committee on Identifying and Preventing Medication Errors. Retrieved from https://nap.nationalacademies.org/read/11623/chapter/2#4. Accessed January 06, 2023.
3. Medication Errors and Adverse Drug Events. (2019). Agency for Healthcare Research and Quality. Retrieved from https://psnet.ahrq.gov/primer/medication-errors-and-adverse-drug-events. Accessed January 06, 2023.
4. Jackevicius CA and Glassman P. (2014). Laboratory monitoring for pharmaceuticals: familiarity does not breed contempt. Journal of general internal medicine, 29(12), 1574-1576. doi.org/10.1007/s11606-014-3048-x