2016

August 29, 2016
SAN DIEGO, Calif., August 29, 2016 – Agena Bioscience today announced the successful certification of Genelex as a Certified Service Provider of the MassARRAY® technology.The MassARRAY System is used to identify and validate SNPs, INDELs, CNV’s, translocations, somatic mutations, including rare variants, and methylation profiles across a variety of sample types. The flexibility and scalability of the platform facilitate easy development of custom panels and validation across large numbers of samples.As a Certified Service Provider, Genelex will provide dedicated customer support, customizable assay design, test development and validation across multiple platforms. The laboratory has integrated robotics and secure Laboratory Information Systems to ensure high accuracy, low error, and rapid turnaround on results.“Certified Service Providers like Genelex enable our customers to perform translational research in a CAP/CLIA environment and receive high quality support and data,” said Marisa Pearce, Sr. Director of Marketing at Agena Bioscience.Genelex is accredited by the College of American Pathologists; certified under the Clinical Laboratory Improvement Amendments Act; is Washington State Medical Test Site; licensed by the New York Department of Health; compliant with Code of Federal Regulations (CFR) 21 and Health Insurance Portability and Accountability Act (HIPAA) and is licensed to perform high complexity clinical testing in all US states.Genelex CSO and Lab Director, Tia Aulinskas commented, “From standard testing to customized assays, Genelex provides actionable data with >99% reportable tests. Our team has the knowledge and experience on the MassARRAY System, and the dedication to ensure the accurate and timely delivery of your data.”About Genelex Genelex is a pioneer in comprehensive medication analytics and pharmacogenetic testing. Genelex’s YouScript Pharmacogenetic testing services are used by healthcare providers, pharmaceutical companies, contract research organizations (CROs), clinical researchers, managed and accountable care organizations. YouScript® Precision Prescribing Software is the only commercially available medication management tool to assess the cumulative effect of a patient’s genetics and entire drug regimen. Founded in 1987, Seattle-based Genelex is one of the first clinical laboratories to provide pharmacogenetic testing and interpretation. Genelex has been providing genotyping services for clinical trials and research studies since 2000. www.Genelex.comAbout Agena Bioscience Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research. The MassARRAY System is intended for research use only, and not intended for use in diagnostic procedures. www.agenabioscience.comMedia Contacts:Genelex Howard Coleman +1 206 826-1963 ColemanHC@genelex.comAgena Bioscience Ryan Ferrell (HDMZ) +1 312 506-5202 ryan.ferrell@hdmz.com
March 15, 2016
Pharmacogenetic testing now available to improve complex medication management for veterans at risk of avoidable hospitalizations and ER visitsSeattle, WA—March 15, 2016Genelex, the makers of YouScript® Precision Prescribing analytics software, announces the U.S. Department of Veterans Affairs has awarded a Federal Supply Schedule (FSS V797D-50565) contract as a government supplier, which will take effect March 15th, 2016. The contract makes pharmacogenetic testing accessible to clinicians in the Veteran’s Administration so their patients can immediately benefit from precision medicine.The YouScript Precision Prescribing System, developed by Genelex, helps eliminate adverse drug events caused by the cumulative impact of multiple medications and genetic variations missed by current drug interaction systems.  Genelex uses a simple cheek swab to detect these variations, and then staff pharmacists provide personalized prescribing suggestions using the YouScript software which includes over 14,000 curated references on drug and gene interactions and how medications are metabolized in a patient’s body. The results not only reveal drug-gene interactions, but interactions between genes and multiple drugs to help providers find the best treatment for patients. After testing, providers can access YouScript in a secure, web-based portal to “audition” new drugs in a clinical decision support tool rather than in a patient’s body.  The software is also able to integrate directly into EHRs and other healthcare software systems.Kristine Ashcraft, Genelex’s CEO stated, “My father, grandmother, and brother are all veterans.  Having first-hand knowledge of the sacrifices they made,  it makes me especially proud to know that this technology is now available to make sure that those who have served are getting access to the safest, most effective medication choices that the current evidence allows for.”  Tests available to veterans include the YouScript Psychotropic Test Panel, which optimizes treatment for patients suffering from mental health conditions such as post-traumatic stress disorder, and the YouScript Polypharmacy Panel, which helps predict response to over three-quarters of commonly prescribed medications including those for pain management, mental health, and heart conditions.The approval will also allow healthcare providers in the Department of Defense, Bureau of Indian Affairs, and the Federal Bureau of Prisons to have access to this technology to reduce healthcare costs and improve patient care.The contract comes after President Obama announced the Administration’s Precision Medicine Initiative in his January 2015 State of the Union Address. The aim of precision medicine is to use a patient’s genomic information, the entire genetic code of the patient, as well as environment and lifestyle to determine the most effective treatment.In a study recently published in the Journal of Medical Economics, the University of Utah showed that the use of pharmacogenetic testing and the YouScript clinical decision support software reduced hospitalizations by 39 percent and ER visits by 71 percent in elderly patients taking multiple medications in just 4 months.  Last month, Genelex announced an enhanced connection with Epic, the U.S.’s most widely used electronic health record system. This new connectivity enables Genelex customers using Epic to better identify patients who are at the highest risk of adverse drug events based on drug-gene and drug-drug-gene interactions which has been proven to significantly lower ED visits and hospitalizations.  Based on over 14,000 curated references and product inserts, YouScript determines the cumulative impact of genetics, prescription and over-the-counter medications, herbals, and other factors offering ranked alternatives when interaction risk is found.About GenelexGenelex is a pioneer in comprehensive medication analytics and pharmacogenetic testing. Their patented YouScript® Precision Prescribing System is the only commercially available medication management system to assess the cumulative effect of a patient’s genetics and entire drug regimen. YouScript is used by healthcare providers, clinical researchers and managed and accountable care organizations. Founded in 1987, Seattle-based Genelex is one of the first clinical laboratories to provide pharmacogenetic testing and interpretation. For more information, visit: Genelex.com or YouScript.com.###Press Contact:Smitha GeorgeGenelex Corporationsmitha@genelex.com206-826-1963 

2015

November 12, 2015
SEATTLE, WASHINGTON; Nov. 12, 2015 – YouScript predictive medication analytics, a clinical decision support tool used by doctors to guide genetic testing and improve drug treatments, has been shown to cut ER visits by almost three-quarters and reduce hospitalizations by more than one-third in elderly patients taking multiple medications.Researchers from the University of Utah compared those who received YouScript-guided genetic testing and analysis in a prospective group to those who did not in a matched retrospective cohort. The retrospective cohort was obtained from Inovalon’s More2 Registry, a large nationally representative, de-identified claims database. Researchers devised this strategy to meet the challenge of providing closely matched controls to the elderly patients taking multiple medications, also called polypharmacy.YouScript was shown to reduce ER visits by 71 percent and hospitalizations by 39 percent in the tested population compared to the statistically matched group.“To our knowledge, this is the first study to demonstrate the potential of a technology to reduce the adverse drug event epidemic caused by polypharmacy,” said Howard Coleman, co-founder and CEO of Seattle-based Genelex, which invented the YouScript system.“Designing a study capable of tackling the polypharmacy problem was a major challenge, and our hats are off to the University of Utah scientists and others who helped with the study design.”The data showed YouScript prevented one hospitalization for every 16 patients tested, and one ER visit for every nine tested. Researchers estimated potential cost savings per patient in the tested group at $218 in just four months. The results of this IMPACT study (Improving Medication Protocols and Abating Cost of Treatment), a collaboration of researchers at the University of Utah and Genelex Corporation, were published October 21, 2015, in the Journal of Medical Economics.The YouScript system combines comprehensive predictive medication management analytics with pharmacogenetic testing, or DNA drug-sensitivity testing as it is also known, to analyze the complex web of medication and genetic interactions affecting how patients respond to drug treatments. The software analyzes patient medication regimens and genetic test results to predict the potential for negative side effects and treatment failure.When potential problems are identified, YouScript suggests alternative medications with reduced interaction risk, while taking into account all other relevant medications and genetic factors. The testing reveals natural variations present in more than 90 percent of people that determine how the body processes more than three-quarters of commonly prescribed medications.The study examined two groups of 65-and-older patients taking three-or-more medications:
  • The first group, a prospective patient registry, received testing for differences in six liver enzymes that process most commonly prescribed drugs. YouScript analytics were then used to analyze the test results, and a clinical pharmacist provided personalized dose change recommendations.
  • The second group, a matched untested control group, was obtained from a large healthcare data warehouse.
The study compared healthcare resource utilization and estimated costs between the two groups to determine the impact of YouScript testing and analysis. Genelex provided an unrestricted research grant to fund the study.“Real world evidence is limited in the field of pharmacogenetic testing with clinical decision support. This study provided an innovative methods approach to provide preliminary data to support health technology assessment for public and private payer reimbursement decisions,” said primary investigator Dr. Diana Brixner, PhD, RPh, Professor of the Department of Pharmacotherapy at the University of Utah College of Pharmacy.“Our results warrant contingent reimbursement and further validation through a randomized trial in a unified population.”Polypharmacy in the ElderlyPolypharmacy has become one of the most serious medical problems facing the elderly today. On average, individuals 65 to 69 years old take 14 different prescribed drugs per year, while those 80 to 84 take an average of 18.Interactions between drugs are a well-known cause of negative side effects but are in the minority compared to the cumulative effective of drug-drug, drug-gene and drug-drug-gene interactions that are taken into account by the YouScript system. These potential interactions involving genetics further increase the risk of unintended drug treatment consequences, especially in the elderly.The potential cost-savings that can result from widespread deployment of the YouScript system, in addition to other medication management advances, is significant. According to the Centers for Disease Control and Prevention, adverse drug events cost the U.S. health system approximately $3.5 billion annually.1Limited Medicare CoverageThe growing body of evidence supporting the importance of genetic variation and drug response may assist Medicare in reconsidering the currently limited coverage of many of these tests. Payment denial could impact as many as 19 million of the 49 million Medicare beneficiaries in the U.S. who are at special risk of costly adverse drug events.2“If we extrapolate these results to all 52 million Medicare recipients, it would mean almost $1 billion in predicted savings,” Genelex Chief Operating Officer Kristine Ashcraft said.“We look forward to working with Medicare to further deploy this technology to improve the lives of our most at-risk seniors while reducing healthcare costs.”The study results came as no surprise to Elise Astleford, a 74-year-old Washington State resident whose life was changed by the YouScript system. YouScript pharmacogenetic testing revealed that her genetic makeup was likely causing her to poorly process a common antihistamine, resulting in forgetfulness and what appeared to her to be the beginnings of dementia.After Astleford was taken off the medication, her memory returned to normal. Now Astleford brings her YouScript test results with her to every doctor visit.“I just believe in it because I feel so much more confident, and I feel I’m armed for my own benefit whenever a doctor wants to prescribe me a new drug,” Astleford said.“For me, it’s the peace of mind that’s quite wonderful.” About GenelexGenelex is a pioneer in comprehensive medication analytics and pharmacogenetic testing. Its patented YouScript® Personalized Prescribing System is the only commercially available medication management system to assess the cumulative effect of a patient’s genetics and entire drug regimen. YouScript is an Allscripts Developer Program Approved Application and is used by healthcare providers, clinical researchers and managed and accountable care organizations. Founded in 1987, Seattle-based Genelex is one of the first clinical laboratories to provide pharmacogenetic testing and interpretation. For more information, visit: www.genelex.com or www.youscript.com.Contact: Kristine Ashcraft Chief Operating Officer Phone: 206.826.1957 Email: KAshcraft@genelex.comMore about the IMPACT Study: www.genelex.com/youscript-impact/IMPACT Study Citation: Brixner D, Biltaji E, Bress A, Unni S, Ye X, Mamiya T, 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. Journal of medical economics. 2015:1-40. PubMed PMID: 26478982.Pharmacogenetic testing Information for patients: http://genelex.com/patients/Genelex Media Kit: www.genelex.com/media About Dr. Diana Brixner and the Department of Pharmacotherapy at the University of Utah College of PharmacyDr. Diana Brixner, PhD, RPh, is a Professor and Executive Director of the Pharmacothearpy Outcomes Research Center in the Department of Pharmacotherapy College of Pharmacy, and Director of Outcomes at the University of Utah Program in Personalized Health. She is a past president of the International Society for Pharmacoeconomics and Outcomes Research.The Department of Pharmacotherapy in the College of Pharmacy at the University of Utah is committed to developing the highest level of work in the education of future pharmacists, research in the pharmaceutical sciences, and service to the institution, the community, and the profession. Through this commitment, the department strives to be a national leader in the application of the pharmaceutical sciences to personalized medicine, thereby realizing improved healthcare delivery to patients through optimized medication outcomes. About InovalonInovalon is a leading technology company that combines advanced cloud-based data analytics and data-driven intervention platforms to achieve meaningful insight and impact in clinical and quality outcomes, utilization, and financial performance across the healthcare landscape. Inovalon's unique achievement of value is delivered through the effective progression of Turning Data into Insight, and Insight into Action®. Large proprietary datasets, advanced integration technologies, sophisticated predictive analytics, data-driven intervention platforms, and deep subject matter expertise deliver a seamless, end-to-end capability that brings the benefits of big data and large-scale analytics to the point of care. Driven by data, Inovalon uniquely identifies gaps in care, quality, data integrity, and financial performance – while bringing to bear the unique capabilities to resolve them. Providing technology that supports hundreds of healthcare organizations in 98.2% of U.S. counties and Puerto Rico, Inovalon's cloud-based analytical and data-driven intervention platforms are informed by data pertaining to more than 769,000 physicians, 261,000 clinical facilities, and more than 123 million Americans providing a powerful solution suite that drives high-value impact, improving quality and economics for health plans, ACOs, hospitals, physicians, consumers and pharma/life-sciences researchers. For more information, visit www.inovalon.comSources 
  1. Based on current figures from the Kaiser Foundation in a recent study about the incidence of high-risk medications in patients 65 and over, and phenotype frequency data.
  2. http://www.cdc.gov/medicationsafety/basics.html
 
April 14, 2015
 
Written by Marty Stempniak, H&HN Staff Writer, 4.13.15

HospitalsandHealthNetworks

Pharmacogenomics tells hospitals how patients will react to drugs before they even take them.

Precision medicine — tailoring care to each unique individual based on his or her genetics — has long been talked about in fuzzier, gee-whiz terms. Now it’s quickly becoming a hot topic in everyday clinical reality.Since President Obama announced his Precision Medicine Initiative during the State of the Union address earlier this year, it seems as if every other day I get an announcement from another hospital or insurer dipping its toes into the space.While cutting-edge provider organizations like the Mayo Clinic and Geisinger already have dived headfirst into this field, the uptake has been slow industrywide. Hospital leaders have a lot on their to-do lists to worry about and may be loathe to add another item. Yet, precision medicine has the potential today to ease some of the biggest pain points that hospital execs are dealing with on an everyday basis.Adverse drug events are a massive problem in health care — Medicare spends some $3.5 billion in extra medical costs on them every year, and they are responsible for 2 to 8 percent of readmissions, John Nelson, M.D., former president of the American Medical Association and practicing obstetrician in Utah, told me. Pharmacogenomics, or analyzing a patient's genetic information with the swab of a cheek to see how he or she will react to a drug before taking it, has the potential to eradicate that problem.Medical practice needs to catch up with medical science, and it’s “repulsive” that it can take 17 years for innovations to make it from bench to bedside, says Nelson, who is also medical director of vendor Genelex, which works in the pharmacogenomics space.“It’s fair to say that, in our industry, there is some frustration given that we have something that could be very beneficial, but the adoption of this has been somewhat slow for various reasons,” he says, one of which is an estimated shortage of 30,000 clinical geneticists. “Hospitals and other organizations are going through a trying time. There’s a lot on their plates right now, and to add one more very complex, often not well-understood circumstance is a challenge. But I think we’ve got to find a way to show that this meets the goals of the Triple Aim.”In a webinar that Nelson hosted last month, he argued that health care needs to reach a point where it sees gene-drug interactions in the same light as drug-drug interactions. About one-third of significant risk of an adverse drug event, he noted, is tied to a patient’s genetic makeup. Some patients break down a drug far too fast, while others may metabolize too slowly, both impacting its effectiveness. About 75 percent of patients have at least one variation in the metabolic factories in their livers and intestines, and do not metabolize drugs normally, he added.Nelson gave one example of an elderly man who was processing his antidepressant too slowly, causing the drug to build up in his system, leading to dizziness and falls. With such a genetic test up front, the doctor would know before a pill is taken, and then switch to an alternative medication to avoid a hospital stay that could have cost the system tens of thousands of dollars.Hospital leaders need to start seeing such efforts as worthy of investment today, he believes, to help alleviate problems that could pop up tomorrow.“I'm afraid right now that most hospital leaders see this as a cost, not as a benefit, and I think it’s up to us in the industry to make sure that we show that cost-benefit, which is exactly what we're trying to do at our company, as well as many others,” he told me, later adding, “There is no magic bullet for fixing the health care system. However, I do believe that there is some magic buckshot — good-sized things that could help, and this is one of them.”The original article can be found on Hospitals and Health Networks here

2014

June 18, 2014
2014_SBM_Best CompanyGenelex, a pioneer in pharmacogenetic testing, analysis and comprehensive medication management software that helps medical professionals understand the interaction between a patient’s genetics and their entire drug regimen, announces its selection as one of the top 100 mid-sized companies to work for in Seattle, for the third consecutive year.Seattle Business magazine’s annual award is based primarily on anonymous input from employees; winners are then selected from a panel of distinguished local business leaders. Employees are surveyed about what makes them happy with their work – on topics from company leadership, benefits, work environment, and innovation in training programs. The awards were presented Tuesday evening at the magazine’s Award Gala.Founded in 1987, Genelex has been on a fast-track trajectory of growth since it began focusing on pharmacogenetic testing (also known as drug sensitivity testing) in 2000.  The company’s mission, “science that benefits humanity,” as well as its people-first, entrepreneurial environment make it a highly attractive employer.“We’ve grown from a small, family-owned company to now employing more than 100 people,” says Howard Coleman, Genelex co-founder and CEO. “It’s gratifying to see our caring company culture and commitment to quality continue while growing at such a high rate. It’s exciting to meet and hire the young professionals motivated by our culture and potential, as we continue to make advances that have a real positive impact on healthcare.”According to Seattle Business magazine, a record number of companies large and small from all over the state entered this competition. “To make the list this year especially, when so many did not, is a powerful statement about how winning companies treat their people,” notes Michael Romoser, associate publisher of Seattle Business.To learn more about Genelex and current employment opportunities, please visit www.Genelex.com

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 About GenelexGenelex is a pioneer in comprehensive medication management, pharmacogenetic testing and analysis. Its patented YouScript® Personalized Prescribing System is the only medication management system to assess the cumulative effect of a patient’s genetics and entire drug regimen to help prevent unwanted side effects and treatment failures.  YouScript was a finalist in the Allscripts Open App Challenge, and is used by healthcare providers, clinical researchers and managed and accountable care organizations. Founded in 1987, Genelex is based in Seattle and was one of the first labs to provide pharmacogenetic testing and interpretation.  For more information, contact the company at 800.TEST.DNA or visit www.genelex.com or www.youscript.com.

2013

September 11, 2013
Puget Sound Business JournalAfter a record-breaking time of expansion, Genelex makes Puget Sound Business Journal's prestigious list of top 100 fastest-growing private companies in 2013.  Read full article.

2000

January 25, 2000
Seattle Times - Mekeisha Madden - Tests taken by Genelex Laboratories in Seattle found a 99.44 percent match between DNA taken from the bones and genetic material taken from the Castillo family members.