Who Are We? Molecular Testing Labs is a cutting-edge molecular and genetics testing laboratory focused on pharmacogenomics. Our primary goal is to provide the physician, healthcare practitioner and patient with the information necessary to understand how a patient’s unique gene families interact and impact specific drug responses. Molecular Testing Labs is a CLIA approved (#50D ) Molecular / Genetic Testing Laboratory.

Pharmacogenomics Pharmacogenomics (PGx) Phar-ma-co-ge-no-mics Pharmacogenomics - the influence of genetic variation on drug response in patients. The goal of Pharmacogenomics is to develop optimized drug therapy with respect to the patients' unique drug response.

Personalized Medicine Personalized medicine is a medical model that proposes the customization of healthcare, with decisions and practices being tailored to the individual patient by use of genetic or other information.

FDA The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have also released directives and drug label warnings in support of genetic pharmacological testing.

Trial-and-Error vs. Personalized Medicine

FDA The term “personalized medicine” is often described as providing “the right patient with the right drug at the right dose at the right time.” More broadly, “personalized medicine” may be thought of as the tailoring of medical treatment to the individual characteristics, needs and preferences of a patient during all stages of care, including prevention, diagnosis, treatment and follow-up. Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development

MAYO CLINIC “Personalized Medicine, if adopted correctly, should improve patient outcome while reducing cost of care.” Dr. Thomas Moyer oversees the Laboratory Medicine and Pathology Department at Mayo Clinic

MAYO CLINIC “I predict in the future that we might envision that a physician will, in addition to the usual workup, order a targeted set of genetic tests to help decide what drug or therapy will be optimal for the patient. So the patient might have to show the pharmacist his or her pharmacogenotype before being given the prescribed drug and appropriate dosing information.” Dr. Thomas Moyer

U.S. Government Support of Personalized Medicine “The Personalized Health Care Initiative will improve the safety, quality and effectiveness of healthcare for every patient in the U.S. By using ‘genomics,’ or the identification of genes and how they relate to drug treatment, personalized healthcare will enable medicine to be tailored to each person’s needs. “Healthcare that is proactive, instead of reactive, gives the patient the opportunity to become more involved in their own wellness. ” U.S. Department of Health and Human Services

What is Tested 1.Pain Management Drug Response – tests to help determine the patient’s response to common pain medications and opioids. 2.Cardiac Risk Factors – tests to determine the genetic risk factors for thrombosis or prothrombin deficiency. Includes evaluating patient’s response to commonly used cardiovascular drugs. 3.Psychotropic/Neurotropic Drug Response – tests to help understand the patient’s response to neuroactive drugs. These drugs include antidepressants, antipsychotics and anxiolytics. 4.Hormone Interaction Response – tests to understand the patient’s response to common hormone replacement therapies. 5.MTHFR Testing – testing for a gene related to folic acid metabolism, which is related to a variety of birth defects and neural tube defects. 6.Infectious Disease Testing – molecular-based tests for common infectious organisms, particularly STDs such as Chlamydia, Gonorrhea, Human Papillomavirus, as well as Hepatitis viruses.

Using the Tests Results For each drug test requested, Molecular Testing Labs provides an analysis of the patient’s genetic response to that specific drug, classifying them as: – Normal Metabolizers (NM) – Poor Metabolizers (PM) – Intermediate Metabolizers (IM) – Rapid Metabolizers (RM) – Ultra Rapid Metabolizers (URM)

The Tests Results The patients medication sensitivities will be indicated based on risk using the following indicators:

The Tests Results

The Test Results

The Tests Results Medications will be categorized and recommendations for prescription management will be given in the following areas: 1.Cardiovascular 2.Diabetes 3.Gastrointestinal 4.Infections 5.Pain 6.Psychotropic 7.Transplantation 8.Urologicals

The Tests Results Cardiovascular Example

Yellow Highlight Indicates FDA/EMA Recommends PGx Test Celebrex Acetaminophen (Tylenol) Plavix Warfarin Codeine

PAIN MANAGEMENT EXAMPLE

Pain Management More than 116 million Americans suffer from acute or chronic pain each year More than 2/3 of all emergency room patients are present for pain management

State of Pain Management Drugs are the “first line” of treatment for most forms of pain. Goal of successful pain management is to effectively control patient pain without causing excess side effects from the medication prescribed. However, only 58% of those who took prescription medication received any form of pain relief. Less than 41% of patients taking over- the-counter pain medication reported relief. Source: Peter D. Hart Research Associates – Americans Talk About Pain: Survey Among Adults Nationwide, Aug. 2003

Dosing Management The incidence of unintentional (and preventable) overdose- related deaths is growing exponentially. Of all drug-related deaths in the U.S., 43% are due to pain relief medication. 80% of all pain management drugs are prescribed by the general practitioner or the internist Sources: American Academy of Pain Medicine; CDC; IMS Institute of Healthcare Informatics The CYP2D6 gene metabolizes 25% of all prescribed drugs, such as codeine, tricyclic antidepressants (eg, nortriptyline), SSRI fluvoxamine, SSNRI venlafaxine, classical antipsychotics (eg, haloperidol), and beta-blockers.

Analgesic Related Deaths The rising death toll is attributed to an increased use of a class of drugs known as Opioid Pain Relievers. Sources: CDC; IMS Institute of Healthcare Informatics The Opioid Hydrocodone was the most frequently prescribed drug in the U.S. in 2010, with million prescriptions

Economics of Testing The U.S. Government understands the cost of molecular pharmacological testing and fully reimburses the cost of these tests through Medicare. The superordinate goal is to save monies on the overall cost of the treatment by mitigating the cost consequences of inappropriate dosing and use of pain management drugs. Source: 1: INMAR: Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011; 2: Castro, et. al. “Pharmacogenomics in the Clinic”, American Society of Clinical Oncology, Journal of Oncology Practice, million people suffering from pain each year in U.S. 1 $250-$500 per patient for adverse event prevention testing 2 $29-$58 billion in total testing costs each year in U.S. X =

Summary The FDA has issued numerous bulletins and updates to product labels informing clinicians and the public of these dangers, and how they can be assessed with genetic testing. Dosing algorithms are/soon will be updated to account for genetic guidance. The goal of Molecular Testing Labs is to provide physicians and their patients with insight into their unique response to pain medications in order to decrease the number of adverse reactions and to better manage their pain medication strategy.

WHY PERSONALIZE? Why should you incorporate personalized medicine into your practice? 1.Improved Patient Care 2.Reduced Liability 3.No Added Expenses to Your Practice 4.Increase Practice Profitability through Test Interpretation (GO452)

SIMPLE PROCESS 1.Doctor Registers with MTL through Personalized Medical Services. 2.Patient Test Ordered 3.Buccal Swab is Completed (2 minutes) 4.Sample Shipped Overnight to Lab 5.Sample is Analyzed, Insurance is Billed and Results are Prepared by Lab 6.Patient Report is Placed into Physician Portal 7.Patient Treatment is Adjusted Based on Results

Personalized Medical Services & Molecular Testing Labs Helping You Help Yourself