OraSure Technologies, Inc. Oral Fluid Drug and Alcohol Testing

OraSure Technologies, Inc. Oral Fluid Drug and Alcohol Testing

Agenda March 15, 2018 02 01 Introductions Midwest Builders Casualty OraSure 04 Q.E.D. Oral fluid Alcohol Test. 02 What is Oral Fluid and Intercept? 03 Trends in Drug Testing What are the most common trends today in drug abuse? 2

What s on Everyone s Mind How can I switch to oral fluid testing? What regulations should I follow? Should I still test for Marijuana? How accurate is oral fluid drug testing for THC? What is my ROI? What do I do about testing for prescription drugs? How can I switch to oral fluid testing? How does oral fluid compare with other test types? 3

What is Oral Fluid? Oral fluid / saliva Combination of 3 glandular fluids, some minor glands. Blood/Serum-like fluid we call oral fluid. Drugs cross over from the blood stream into oral fluid allowing us to test for them. 4

Oral Fluid vs. Urine Drug Testing Positivity rates general workforce samples (non-regulated)* Overall Positivity Drug Test Urine Analysis (%) Oral Fluid Analysis (%) Marijuana 2.4 7.5 Cocaine 0.25 0.46 Amphetamine 1.11 0.56 Opiates 0.49 0.78 PCP 0.02 0.04 Methamphetamine n/a 0.29 Accuracy and performance like this has convinced HHS to add laboratory based oral fluid testing to the SAMHSA Federal guidelines. 5

Windows of Detection for Various Matrices Did You Know? Oral fluid detection starts about 15 minutes after drug use and continues for 2-3 days depending on various factors. 6

Benefits of Oral Fluid Drug Testing Lab-based solutions Eliminates Collection Hassles, Reduce Costs Eliminates Drug Test Cheating Maintains Superior Laboratory Confidence Safeguards Legal Defensibility 01 02 03 04 Expedite specimen collection Observe collection Capture Under the influence Certified MRO confirmation Eliminate collector gender issues Non-invasive collection Capture accurate positive rates Established chain-of-custody Eliminate shy bladder Eliminate substitution Test for current drug trends Comprehensive donor inclusion Collect anytime/anywhere Eliminate dilution SAMHSA approved laboratories Scientifically proven technology Collect in any environment Eliminate additives GC/MS and/or LC/MS confirmatory testing Hundreds of peer-reviewed journal articles 7

02 Urine Adulteration & Tampering Easy and Effective Eliminates Drug Test Cheating All are ineffective using oral fluid It s big business Ways to beat a urine test Dilution (most common) Substitution Masking agents Did You Know? A Google inquiry on How to pass a drug test in 24 hours yields more than 5,030,000 results. 8

04 How Well Does Oral Fluid Testing Hold Up in Court? Safeguards Legal Defensibility Court Decisions Rockland Cty v. NY Family Medina Cty v. Hixon Medina Cty v. Hixon 2 Frye Rule Chain of Custody. Ruling demonstrates judicial recognition and acceptance of scientific and persuasive evidentiary value of Intercept results. Performance. Ruling demonstrates judicial recognition and acceptance of scientific and persuasive evidentiary value of Intercept results. Lab Procedures. Testimony of both screen and confirmation demonstrated 99.5% accuracy in results to withstand counterclaim.. Admissibility. General consensus of the scientific community that a given technique is reliable. Oral fluid drug testing withstands the legal scrutiny. Did You Know? In U.S. federal courts, admissibility of scientific evidence is governed by the 1975 Federal Rules of Evidence. 9

Intercept Oral Fluid Test Not all oral fluid tests are alike #1 Recognized Brand in Oral Fluid Testing FDA cleared drugs of abuse oral fluid testing system On-site collection laboratory analysis Collection pad and handle Low level of salts on pad to help generate oral fluid Easy grip handle with flag serves to show correct orientation in mouth 10

Intercept Oral Fluid Drug Test Not all oral fluid tests are alike Specimen Integrity Ensured for up to 21 Days Specimen vial Preservative stabilizes sample for shipment 21 day stability before testing Designed to accommodate tamper seal 11

Oral Fluid Collection Process is Fast and Easy Using the OraSure Intercept Device Swab Ease of collection: 3 easy steps Snap Seal 12

Intercept Oral Fluid Test Common drug panels 10 Assay Menu Marijuana (parent THC) Cocaine Opiates Amphetamine Methamphetamine including MDMA (Ecstasy) Phencyclidine (PCP) Barbiturates Benzodiazepines Methadone Oxycodone Ask about expanded panels with your laboratory Other: Cotinine (Tobacco assessment) 13

Why Intercept Oral Fluid Drug Testing? Collect anytime / anywhere Saves Time and Money No Need for Collection Site No collection fees Reliance on collection site hours/locations No NO shows Improves Productivity Establishes Market Competitiveness Improves Testing Attitudes Oral Fluid Value Reduce Employee Time Away From Work Reduce time away from work for high wage employee collections Reduce time away from work for high wage employee collectors Removes Same Sex Collector Need Dignified Dignified collection Gender neutral No dedicated facility for onsite collections 14

Drug Users are in the Workplace 276 Billion Year 76% Drug users are currently employed Estimated cost to U.S. employers per year 15

What is Synthetic Marijuana? The Not for Human Consumption Fake Weed Overview: Dried plant material sprayed with synthetic additives; 4-50Xs more potent than THC. Marketed: Sold as incense that can be smoked. Resembles potpourri. Street names: K2, Blaze, Spice, Red X Dawn, Bliss, Black Mamba, Fake Weed. Affect: Similar to THC: paranoia, panic attacks, giddiness to heart attacks. Up To 2% Positivity rate Many employers have added to their drug panels. Did You Know? It s Not Just for Kids. SAMHSA estimated 28,500 ED visits in 2011 alone. Recent Users Median Age: 35 years old. 16

Opioid Prescriptions It s a national addiction problem 2012 Number of Opioid Prescriptions per 100 People 96-143 82.2-95 72 82.1 52-71 Did You Know? By 2009, Americans consumed 99% of the worldwide production of hydrocodone and 81% of oxycodone. Over 12.2 million Americans reported using non-medically. 17

Heroin Deaths Surpass Gun Homicides in 2015 Did You Know? Oral fluid testing detects the primary heroin metabolite 6-AM more effectively than urine and hair. 18

Fentanyl The King of Synthetic Opioids 100 times more potent than morphine Overview: Synthetic opioid analgesic used to treat severe pain. Street fentanyl is disguised or often laced in heroin. Marketed: Prescription patch or pills disguised as oxycontin. Street names: Fake Oxy, greenies, green beans and green monsters. Affect: Euphoria, increased energy, distorted perception to liver & kidney failure, and death. 73% Increased death rate From 2014 to 2015. Did You Know? Ohio has the highest testing rate incidents. Fentanyl reports increased 72Xs in just 5 years. 19

Have You Seen Molly? MDMA (Ecstasy) - NOT the girl next door. Overview: Synthetic modified amphetamine drug in pill or capsule form typically taken with other substances. Marketed: Often blended with other drugs such as bath salts. Street names: Ecstasy, molly, dancing shoes, hug drug, Scooby snacks. Affect: Euphoria, increased energy, distorted perception to liver & kidney failure, and death. 6.8% Surveyed Individuals Have tried MDMA at least once in their lifetime. Did You Know? Since 2012, MDMA positivity rates has increased 5X in the workplace. 20

Amtrak Accident, Chester, PA April 3, 2016 Engineer s post-accident drug test positive for THC & worker positive for opioids 2 Amtrak Worker s Killed A 106mph train collided with a backhoe doing work on the tracks: 2 Amtrak workers killed 341 passengers were on board Cause of accident: miscommunication Tested positive for drugs: Engineer marijuana Worker #1 cocaine Worker #2 opiates 30 Million Estimated damages train and tracks Additional injury lawsuits pending! 21

BMW Plant, Munich, Germany March 3, 2017 2 employees and their smoked joint shuts down assembly line 2 Employees Collapse on the Job 2 employees smoked a joint in locker room prior to evening shift Collapsed on the job shutting assembly down Tested positive for drugs: Worker #1 THC & alcohol Worker #2 THC & amphetamine Source: Bild Report, March 20, 2017 1+ Million Estimated cost for 40 minute shut down Additional off-site medical expenses 22

Construction Industry Second highest rates of substance abuse in the workplace 1 in 9 construction employees abuse illicit drugs 3 out of 4 construction managers perceive substance abuse to be a serious problem Construction accounts for the highest rate of accidental fatalities of any industry 51.8% 4.4% of employer compensation costs in construction were spend on workers compensation; nearly 3 times more compared to all other industries Drug-testing programs result in 51% reduction in incident rates within 2 years of implementation in9 Construction workers abuse illicit drugs 23

Why Does a Company Drug Test? Motivational influencers Required DOT, contractor screening, co-employment Hiring assessment for a better candidate Deter drug use in the workplace Reduce common business costs (health insurance, worker s comp, etc.) Detect use It may be one or many 24

Who is Drug Tested? 2017 National Safety Council Employer Survey Which part of your workforce is drug tested? All employees 83% Employees operating machinery/tools/vehicles 16% Employees with financial responsibility Supervisors / managers 2% 2% 57% Employers perform drug testing Fewer employers in the New England area (-18%) Client-facing employees Office-based employees 2% 1% 25

Drug Testing Works! Annual positivity rates 26

Should I still Should I test for still test for Marijuana? Marijuana? States That Have Legalized Marijuana Did You Know? Oral fluid testing detects recent use of marijuana ruling out the PAST USE excuse. Legalized for medical use only Legalized recreational & medical use No broad laws legalizing marijuana 27

Should I still test for Marijuana? Should I Still Test for Marijuana? 01 02 03 It s still an illegal substance under federal law Schedule I Controlled Substance In August 2016, DEA stated marijuana will remain a Schedule I drug. Court Ruling Courts have ruled in favor of employers stating that marijuana is not protected as a lawful off-duty activity and is illegal under federal law. Employers Rights Employers have the right to prohibit use or impairment in the workplace. U.S. DOT and other federal employers still require testing for marijuana. Best Practice Be clear in the company policy Define prohibited behaviors Establish drug testing protocol (how, when and for what drugs) Identify consequences for policy violations Be clear that employees cannot possess or use marijuana in the workplace or be under the influence Define Under the Influence policy Indicate detection of any amount is a violation of company policy Take measures based upon actions rather than drug test results (reasonable suspicion) 28

Should I still test for Marijuana? Should I Still Test for Marijuana? Here s what testing can reveal about your employee / applicant Employee Assessment Testing is a single assessment data point of employees or candidates and reveals the following: Does or doesn t use the drug Gave up long enough to get a job Doesn t make risky decisions when in a workplace that tests Researched the company s drug testing policy Has a habit that she / he couldn t stop Wants to tell you why it should be legal 29

Should I still Should I test for still test for Marijuana? Marijuana? Should I Still Test for Marijuana? Impact and outcomes shouldn t be surprising WORKPLACE IMPACT TESTING OUTCOMES Performance Inconsistent quality Lower productivity Poor concentration and focus Performance Increase stability Increase productivity Increase moral Absenteeism / Medical Expenses Unexplained disappearances Extended lunch periods and early departures Increased healthcare expenses Accidents Needless risk taking Disregard for safety of self / others Driver accidents Absenteeism / Medical Expenses Reduce employee absences Reduce employee turnover Decrease healthcare costs Accidents Safer work environment Decrease workman s compensation $ Decrease litigation expenses Decrease tax liability 30

Should I still test for Marijuana? What are Employers Saying About THC? 75% Concerned Employers Decrease of quality of new/hires in workplace. 98% Will Continue to Test for THC 31

How accurate is oral fluid drug testing for THC? Marijuana Positivity Rates Here s how recreational marijuana is effecting the general workforce 9 8 7 6 5 4 3 2 1 0 % % % % % % % % Washington Initiative 502 2009 2010 2011 2012 2013 2014 2015 2016 Urine Oral Fluid Hair Colorado Amendment 64 California Bill Prop 64 Did You Know? Since 2012, oral fluid drug testing has realized doubledigit positivity rate increases among the general workforce. 32

How accurate is oral fluid drug testing for THC? Lab-based Oral Fluid vs. Urine Drug Testing Overall Positivity Positivity rates general workforce samples (non-regulated)* Drug Test Urine Analysis (%) Oral Fluid Analysis (%) Marijuana 2.5 8.9 Cocaine 0.28 0.63 Amphetamine 1.20 0.66 Opiates 1.197* 0.71 PCP 0.01 0.05 Methamphetamine n/a 0.42 2.5Xs Oral fluid THC positives were greater than urine positives in 2016. 33

How accurate is oral fluid drug testing for THC? Oral Fluid Lab-based vs Rapid Testing 50 ng/ml Lab-based Test Detection Range 80% Marijuana Positives Below 50 ng/ml oral fluid cutoff (65% of all THC positives are below 25 ng/ml) N=2407 20% Marijuana Positives Above 50 ng/ml oral fluid cutoff Rapid Test Detection Range 34

How does oral fluid compare with other test types? Lab-based Urine Testing PROS ABOUT CONS US PROS Considered the standard in drug testing. Allowed in Federal and DOT testing. Provides an electronic chain of custody for DOT and non-dot. ~18,000+ collection sites. Variable costs depending on the collection site. Variation of drug panels including MedPro. Upheld in courts, widely accepted in most states and programs. CONS Adulteration or dilution 1 to 3% requiring retesting along with delayed hiring. Requires direct observed collection and/or dedicated bathroom facility. Requires special training. Window of detection does not detect near term use impacting preemployment testing in the era of legal marijuana, post-accident/reasonable suspicion for impairment testing. Gender specific collections. Embarrassing for donor. May not meet ADA compliance for shy bladder donors. 35

How does oral fluid compare with other test types? Rapid Urine Testing PROS ABOUT CONS US PROS CONS Instant results for determining negative results quickly. May be conducted by trained personnel on-site. Less expensive compared to labbased tests. Offers various test panel combinations Complex collection procedures. Results are interpreted by supervisors. Inconsistent tracking of results. Requires special facilities for onsite collections. Prohibited in several states. May not meet ADA compliance with bladder shy donors. The Yuck factor 36

Building Blocks of an Oral Fluid Program How can I switch to oral fluid testing? 5 basic elements 8 easy steps 37

How can I switch to oral fluid testing? Making the Switch 8-easy steps to save valuable time and money 1. Review your policy Confirm that you are able to use lab-based oral fluid in your state. 2. Update your policy Ensure that the panels are accurate, testing method includes lab-based oral fluid. 3. Choose a lab Even if you have a laboratory, work with your provider to review current and any future panel needs. 38 4. Confirm your inventory needs Use your real testing data and device expiration to decide how many and how often to order.

How can I switch to oral fluid testing? Making the Switch 8-easy steps to save valuable time and money 5. Customize training Device training will be provided by your manufacturer. Be sure to review your program as well. 6. Provide Materials Provide reference materials for your managers and staff. 7. Set a Date Set a date for training and allowances for implementation. 39 8. Schedule an evaluation Schedule time with your provider post roll out to evaluate program effectiveness (30, 60, 90 rule).

Q.E.D. Saliva Alcohol Test Accurate Results With 98% Correlation to Blood GC Accurate results in 2 minutes Built in QA Spot Confirmed with breath/blood DOT-approved FDA-cleared CLIA-waived

Q.E.D. Saliva Alcohol Test The First DOT-approved, FDA-cleared, CLIA-waived Saliva Alcohol Test QA Spot Result scales (0-145 mg/dl) Capillary Entry port

Oral Fluid Testing Process is Fast and Easy Using the Q.E.D. Saliva Alcohol Test Swab Ease of testing: 3 easy steps Insert Read 42

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