2015 pgx catalog

THE HUMAN ADVANTAGEI N L A B O R A T O R Y T E S T I N G

P H A R M A C O G E N E T I C S

R I G H T D R U G R I G H T D O S E R I G H T T I M E

Traditional medicine has employed more of a trial and error approach in a one-size-fits-all environment.

Pharmacogenetic testing provides physicians with their patient’s genotype to determine how each patient personally metabolizes and responds to specific medications.

Advancements in genetics now allows physicians to facilitate genetically tailored treatment plans specific to a patient’s personal metabolic profile.

GENETICS CANACCOUNT FOR 20-95% OF THE VARIABILITY IN AN INDIVIDUAL’S RESPONSE TO DRUGS.

* Belle DJ and Singh H. Genetic Factors in Drug Metabolism. Am Fam Physician. 2008 Jun 1; 77(11);1553-1560.

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PHARMACOGENETIC TESTING ADVANTAGE Personalized MEDICINE

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ADVANTAGES of DNA Testing: • Minimize side effects and/or

unnecessary drug complications • Reduce adverse drug events and

treatment failures • Improve personalized care - and

clinical outcomes • Decrease the “length of stay time” • Increase patient quality care • Provides a layer of complience

Advanta’s painless, non-invasive DNA specimen collection process is CLIA compliant, validated, and approved. Pharmacogenetic tests are covered by Medicare as well as most major commercial insurance carriers.

We simply speed up the process with improved accuracy for medication treatment so that your patients can return to the activity they love.

The TEST PHARMACOGENETIC TESTING ADVANTAGE

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Adverse Drug SOLUTIONPHARMACOGENETIC TESTING ADVANTAGE

A medication error is defined as ”inappropriate use of a drug that may or may not result in harm.” Such errors may occur during prescribing, transcribing, dispensing, administering, adherence, or monitoring of a drug. In contrast, an adverse drug reaction (ADR) is “harm directly caused by a drug at normal doses.”*

•• Among older adults (65 years of age or older), 57–59% reported taking 5 to 9 medications.17–19% reported taking 10 or more over the course of that year.

•• As many as 33% of all potentially clinically significant drug interactions, one of the possible causes of ADEs, are caused by drug-gene and drug-drug-gene interactions and may be missed by drug-drug interaction analysis alone.

MEDICATION ERRORS

ADVERSE DRUG REACTIONSADVERSE DRUG EVENTS

2.2 MILLION SEVERE ADVERSE DRUG EVENTS (ADE’S) OCCUR IN THE U.S. EVERY YEAR.*

*U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author. Pg: 5

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According to the U.S. Food and Drug Administration:

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe:

• Drug exposure and clinical response variability • Risk for adverse events • Genotype-specific dosing • Mechanisms of drug action • Polymorphic drug target and disposition genes

“ “

The LIFELINE PHARMACOGENETIC TESTING ADVANTAGE

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Pharmacogenetic testing is especially significant for people: • Over the age of 65 • Taking multiple medications • Who experience (more than typical or atypical) drug side effects • Taking (one or multiple) FDA approved medications with Pharmacogenetic

information in their labels • Who are not responding to medications or prescription medication programs • People under consideration for a prescription medication program (for general

practice, post-surgical treatment and/or disease management) • Taking complex medication(s) that may inhibit these enzymes in practice • Over-medicated falls in the elderly

The SIGNIFICANCEPHARMACOGENETIC TESTING ADVANTAGE

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Comprehensive PGX Panel Used For: • Cardiology • Internal Medicine • Oncology • Pain Management • Pediatrics • Primary Care • Psychiatry

ROUGHLY 75% OF THE U.S. POPULATION DOES NOT METABOLIZE MEDICATIONS NORMALLY.

75%

The FACTS

With Advanta PGx Test, you treat your patients with the right dose, the right drug, at the right time greatly eliminating the one size fits all approach to traditional medicine.

* Villagra D, Goethe J, Schwartz HI, Szarek B, Kocherla M, Gorowski K, et al. Novel drug metabolism indices for pharmacogenetic functional status based on combinatory genotyping of CYP2C9, CYP2C19 and CYP2D6 genes. Biomarkers in medicine. 2011;5(4):427-38. Epub 2011/08/25. doi: 10.2217/bmm.11.32. PubMed PMID: 21861665; PubMed Central PMCID: PMC3225004.

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PHARMACOGENETIC TESTING ADVANTAGE

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Our genetics laboratroy assesses enzymes (of the Cytochrome P450 System), CYP 2D6, 2C9, and 2C19. These enzymes are relied upon by over 50% of all medications routinely prescribed including cardiovascular medication (i.e. Plavix, Warfarin, ARBs, Beta/Calcium Channel blockers, Antiarrhythmic, etc.), pain medications, NSAIDs, the majority of antidepressants, tamoxifen and more.

Advanta Analytical Laboratories offers a variety of testing options in the emerging field of Pharmacogenetics. Panels have been designed based upon medical specialty to include genes most commonly involved in the metabolism of medications prescribed by that specialty. Not only do these tailored panels provide metabolization predictors, but can also provide physicians with potential toxicity implications, unwanted drug-drug interactions, and medication sensitivity.

The following table describes the panels currently offered:

The Assay PANELS

TESTING PANELSCOMPREHENSIVE TESTING MENU

CARDIOLOGY TESTING PANEL

PAIN MANAGEMENT TESTING PANEL

PSYCHIATRIC TESTING PANEL

CYP450 2D6 CYP450 2D6 CYP450 2D6 CYP450 2D6CYP450 2C9-VKORC1 CYP450 2C9-VKORC1 CYP450 2C9-VKORC1 CYP450 2C9-VKORC1CYP450 2C19 CYP450 2C19 CYP450 2C19 CYP450 2C19CYP450 3A4 CYP450 3A4 CYP450 3A4 CYP450 3A4CYP450 3A5 CYP450 3A5 CYP450 3A5 CYP450 3A5Factor II Plus-V & MTHFR Factor II Plus-V & MTHFR


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Determine patient’s genotype by collecting an oral swab sample.

Swab sample is sent to Advanta Labs to be tested.

Pharmacogenetic test is carefully run on specimen.

Data from test is generated, analyzed, and returned to physician.

The PROCESS

Complete the New Physician Registration Form for Advanta Analytical Laboratories, and we will overnight your Advanta PGx Implementation Kit. Your kit will contain collection and shipping instructions, swabs, tubules, specimen bags, requisitions shipping bags and prepaid return shipping labels.

Our highly complex CLIA and COLA accredited and CAP approved laboratory will cross reference the DNA information through an extensive database of medications and report results within 72 hrs. The report will provide medication and dosing guidance for your patient. A cytogenetisist will be available at all times for questions regarding patient results.


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The LEADERSPHARMACOGENETIC TESTING ADVANTAGE

Owatha “Tootie” Tatum joined Advanta Toxicology as the Laboratory Director in August 2015. Dr. Tatum founded the Texas Tech University Health Sciences Center Laboratory for Molecular Diagnostics and served as Associate Professor in the Departments of Laboratory Medicine and Pathology (2002-2011). She was instrumental in the development of Pathogenius Laboratories and served as the Laboratory Director from its inception (2008-2011). She was also the Director of Project Management for the Joint Genome Institute at Lawrence Berkeley National Laboratory, a massive-scale genome sequencing facility that grew out of the Human Genome Project.

Dr. Tatum is board certified as a high-complexity laboratory director and as a clinical consultant in molecular diagnostics. She also serves as a voting member on the American Board of Bioanalysis (2013-2016), as well as a CAP specialty inspector in molecular diagnostics and team leader.

OWATHA TOOTIE” TATUM, PH.D.L A B O R AT O R Y D I R E C T O R

Dr. Robbins is a motivated hard working laboratorian with a Ph.D. in Biochemistry from the University of North Dakota. He has over 25 years of post-graduate experience in the sciences. This ranges from 12 years in laboratory management in CAP/CLIA environments to conducting research on the bench and developing high complexity urine, plasma and intracellular assays. He completed post-doctoral work at St. Jude Children’s Research Hospital and stayed on conducting 20 years of research in HIV drug metabolism and assay development using HPLC, RIA and LC-MS/MS techniques. Furthering his carrier by joining University of Nebraska Medical Center, Dr. Robbins was instrumental in the design and establishment of the UNMC Antiviral Pharmacology Laboratory while progressing his work in HIV research developing plasma and intracellular drug assays.

His most recent work has involved developing and validating multi-drug LC-MS/MS assays in urine for pain management as he continues other scientific and method development activity at Advanta Analytical Laboratories.

BRIAN L. ROBBINS, PH.D.C H I E F S C I E N T I F I C O F F I C E R

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SOLUTIONS, PRODUCTS, & SERVICE HUMAN ADVANTAGEWhy ADVANTA

MOLECULAR TESTING

DEVELOPMENT

COMPREHENSIVE TOXICOLOGY

CONSULTING LAB & HOSPITAL JOINT VENTURES

WOMEN’S HEALTH • CLINICAL TESTING

PROJECT MANAGEMENT

REFERENCE SERVICES (PRIVATE LABEL)

HOW WE COLLABORATE At Advanta, we value the opportunity to join forces. Together, we can configure the best solution for improving your laboratory testing endeavor. Services that we provide include:

LOOKING FOR ANOTHER TEST?We also offer full service laboratory testing for:

Call 903.707.2197 or visit www.aalabs.com for more information.

CLIA/COLA ACCREDITED

CAP APPROVED

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ADVANTA CUSTOMER SERVICEPhone: 903.707.2197

ADVANTA ANALYTICAL LABORATORIES10935 CR 159Tyler, TX 75703

Phone: 903.805.9955 Fax: 903.839.2494

[email protected]

/advantalabs

@Advanta_Labs

@advantalabs

Advanta Analytical Laboratories

www.aalabs.com

KIRT PRIMEAUXBUSINESS DEVELOPMENT

Advanta Analytical Laboratories

10935 CR 159, Tyler, TX [email protected]

CONTACT US F O R M O R E I N F O

2015 pgx catalog

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