OraSure Technologies Analyst Day

OraSure Technologies Analyst Day November 29, 2016 Nasdaq MarketSite

Agenda Welcome and introductions Infectious Disease HCV Country-Wide Elimination Programs HIV Self-Testing R&D: Emerging Diseases -Ebola, Zika

Tuberculosis (TB) Molecular Personal Genomics Microbiome R&D: Sample Optimization Financial review / Business Development Summary

Forward-looking statements These slides and the associated presentation contain certain forward-looking statements, including statements with respect to revenues, earnings, technology, new

products, product performance, markets, clinical development, regulatory filings and approvals, and business plans. Factors affecting these statements include, but are not limited to, the ability to develop new technology, technology changes,

ability to fund research and development, required regulatory approvals, product performance and market acceptance of products. Please see the Company s SEC filings, including its registration statements, and the Company s most recent Form

10-K and Form 10-Q, for a more detailed description of specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. The Company undertakes no duty to update these statements.

Welcome and introductions Tony Zezzo Executive Vice President, Business Unit Lead, Infectious Disease Mike Reed, Ph.D. Senior Vice President, Research & Development and Chief

Science Officer Cassandra Kelly-Cirino, Ph.D. Vice President, Infectious Disease TB and Emerging Diseases Program Lead Brian Smith Senior Vice President Business Unit Lead, Molecular Aaron Del Duca Vice President, Technology Microbiome Program Lead

Rafal Iwasiow, Ph.D. Vice President, R&D, Molecular

Our company vision Empower healthcare providers and patients worldwide to improve global health through access to accurate, essential information. We will accomplish this through a deep

understanding of our customers needs and a commitment to innovative infectious disease and molecular solutions.

Core strategic growth pillars Grow Molecular business Grow Infectious Disease business Driving unprecedented global access to our existing and new Infectious Disease diagnostics Leveraging

the strength of our Molecular business into new growth markets, with existing and new technology

Strong platform foundation for growth 2004 2011 2005 2006 2007 20102002 2008 2009 2012 2013 2014 2015 2016 2017 Infectious Disease Molecular * *OraQuick Self-Test is currently under review

OraQuick Zika is currently under development 7 Strong platform foundation for growth 2004 2011 2005 2006 2007 20102002 2008 2009 2012 2013 2014 2015 2016 2017 Infectious Disease Molecular * *OraQuick Self-Test is currently under review

OraQuick Zika is currently under development 7

Core growth strategies Molecular Expand beyond sampling to offer incremental value from collection through to reporting via complementary products and services Leverage early

wins in Asia to replicate success in US Focus on standardization and weaving Microbiome into genomics research customer base to drive growth Infectious Disease Expand global access to HIV and HCV products through innovative testing

programs and collaborations Develop and launch new POC diagnostics targeting emerging high burden infectious diseases Develop and launch reagent targeting transport and processing of sputum samples to optimize Tuberculosis (TB)

HCV Country-Wide Elimination Programs Tony Zezzo Executive Vice President Business Unit Lead, Infectious Disease OraSure Technologies, Inc.

HCV opportunities 170 million people infected globally, 4-5 million people infected in U.S. The majority of HCV infection remains undiagnosed Approved drugs,

and those in the pipeline, are driving demand for increased diagnoses and the number of patients initiating therapy Significant reduction in the cost of treatment in developing countries Availability of a rapid, non-instrument rapid

point of care test drives diagnosis through increased testing outside of laboratory Source: CDC

OraQuick HCV Rapid Antibody Test Quality matters Accurate sensitivity and specificity comparable to lab-based immunoassays Versatile -reach patients outside

traditional laboratory testing channels Simple extremely easy to use three step process; use with oral fluid outside U.S. 20 minute results allows for immediate linkage of patient to care and treatment

HCV product revenue 2013-2016 Overall Growth Product Revenue Growth HCV Product Revenue by Segment 2013 Domestic International 56%44% Product revenue growth of 270% CAGR of

28.2% Historical revenue drivers: Domestic Public Health Asia and Large International NGO Future revenue drivers: Country elimination projects Public Health and drug treatment HCV Product Revenue by Segment

2016 Domestic International 48% 52%

Eliminate viral Hepatitis by 2030 WHO leading effort to eliminate viral hepatitis by 2030 36 countries with national plans to combat hepatitis 33 countries formulating national plans

Source: WHO, Combating Hepatitis B and C to Reach Elimination by 2030, May 2016 13

HCV program opportunities (examples) Country 1 Country-wide testing campaign over 12 months $18 million in value, 90% HCV tests Multi-million test kit purchase with

additional purchase option Country 3 Outreach and remote testing initiative Initial order shipped, additional orders anticipated Expected volume of 100K+ Country 2 Rural community and migrant worker program by MOH

Initial pilot order shipped Expected volume of 100K+ Country 4 Test and treat program with local partner Initial order 2017 of 50K tests Expected volume of 100K+ HCV growth programs

Excellent growth prospects Recognized bodies (WHO) have prioritized Hepatitis and Hepatitis C for elimination Price of HCV therapy is significantly reduced in developing

countries Large scale test and treat pilots and country elimination programs are being executed Recognition that all test and treat programs will need a quality rapid test to optimize success OraSure s HCV test is seen as

an ideal solution and is being incorporated into test and treat programs

HIV Self-Testing Tony Zezzo Executive Vice President Business Unit Lead, Infectious Disease OraSure Technologies, Inc.

The need and opportunity ~100MM HIV rapid tests are deployed annually, funded largely by donor agencies 36.7 million people globally were living with HIV (end 2015),

only half of those individuals know their status The majority of undiagnosed individuals have limited or no access to health services Stigma associated with HIV remains an issue The down stream costs of these issues has and will

financially burden health systems Implementation of UNAIDS 90:90:90 initiative to address situation Source: unaids

State of HIV self-testing The first studies conducted by the London School of Hygiene and Tropical Medicine Other studies followed by several notable organizations Two

important outcomes developed: More people chose to test when offered a self test OraQuick was used in all studies for its quality and ease of use UNAIDS sited self testing as an innovation critical to achieving the 90:90:90

The OraQuick HIV self-test Self-test product contains: Standard OraQuick device and vial, single use stand and a package insert placed in an over-pouch for personal use/carry.

Over-pouched for single use Standard device/vial Package insert + single use stand

OraQuick and self-testing Competitive advantage OraQuick track record of success Endorsement from leading KOLs Ease of use and oral fluid matrix Foundation and

validation studies well underway

State of HIV self-testing WHO/UNITAID release landscape report on Rapid HIV self-testing Market for HIV self testing tools is clearly growing Drivers are replacement,

frequency of testing and uptake of testing Early estimates indicate self testing could easily reach 23M tests annually Additional information on demand estimates is expected by the end of 2016 16 countries have adopted HIV self

testing policies others are currently developing them Growing interest from international donors could make low-cost and quality self-testing tools available faster than ever before

Key progress to date UNITAID/PSI STAR program phase 1 initiated in Zimbabwe, Malawi and Zambia Shipped over 400K tests to pilot countries Additional studies initiated

in 6 countries with early stage interest WHO submission received 10/7/2016 WHO pre-qualification opens up funding through various organizations Funding organizations highly interested (Global Fund, PEPFAR, UNITAID)

Next steps Complete Phase 1 (750K units) of UNITAID/PSI initiative and prepare for Phase 2 (1.9M units) Continue ongoing discussions with additional 6 countries to deploy

once WHO prequalification is achieved Initiate studies in additional countries

Summary Major funding organizations are showing high interest in self-testing Volume growth will be significant over the next few years The OraQuick HIV Self-test is

very well positioned as the easiest, high quality, oral fluid rapid test available Self testing is a critical tool in reaching the undiagnosed in middle and low income countries and toward achieving the 90:90:90 millennium development goal

R&D: Emerging Diseases Ebola & Zika Michael Reed, Ph.D Senior Vice President, Research & Development and Chief Science OraSure Technologies, Inc.

Emerging Diseases An emerging disease is one that has appeared in a population for the first time, or that may have existed previously but is rapidly increasing in incidence or

geographic range World Health Organization

Ideal solution for emerging disease First line of defense is identifying and containing infected populations Demand for tests is generally small with sudden peaks during

outbreaks Industry-Public Health collaborations critical to providing robust, rapid solutions Powerful OraQuick platform ideal for rapid response to Ebola and Zika outbreaks Being driven by US Government funding of up to $27M Strong

collaborations with the NIH, CDC and BARDA have been key for innovation and delivery Morens et al., 2004.

OraQuick EBOLA Rapid Antigen Test

Quick and collaborative crisis response 10 month concept to deployment

Impact of Ebola program Providing high impact solution for Ebola Outbreaks in West Africa Ebola control (since 2014 epidemic) CDC has 75 staff in Africa to prevent another Ebola

epidemic Cadaver testing is critical for outbreak management 7 outbreaks since 2014 epidemic have been controlled due to rapid response Built process muscle Rapid innovation and commercialization Scale-up capacity for

major outbreaks Go to company for Public Health collaborations 1 2 5 4 3 6 7

OraQuick ZIKA Rapid Antibody Test 31

The Zika crisis Zika really is unprecedented. Never before have we seen a mosquito-borne virus that can cause birth defects Dr. Tom Frieden, CDC Director Easy transmission

Health effects Flu-like symptoms: 20% of all infections Congenital birth defects: ~5% of pregnancies Guillain-Barre Syndrome: <1% of all infections

Significant rise in Zika infections 67 countries reporting Zika Infections since 2015 171K confirmed cases in the Americas alone AFRICA SE ASIA WESTERN PACIFIC AMERICAS

SITUATION REPORT: ZIKA VIRUS, MICROCEPHALY, GUILLAIN-BARR SYNDROME -17 NOVEMBER 2016

Zika in the U.S. and territories Total infections Pregnant women U.S. & D.C.: 4,444 U.S. & D.C.: 1,114 U.S. territories: 32,724 U.S. territories: 2,561 0 1-11 12-22 23-49

50-100 >101 Local vector-borne transmission States & Territories Reporting Zika Disease Solid shading represents travel-associated cases only Source: https://www.cdc.gov/zika/intheus/maps-zika-us.html#activeflorida; November 23,

Zika health impact All pregnant women in the U.S. and U.S. territories should be assessed for possible Zika virus exposure at each prenatal care visit. ACOG Practice Advisory,

October 18, 2016 Regardless of how WHO defines Zika, it is unprecedented, and it s an extraordinary risk for pregnant women. Tom Frieden, CDC Director Deployed

Zika detection needs Molecular Serological Unmet need Ricketson (2016) WebMed Central, Mar 24 Protein Data Bank Zika Genome detection Zika IgM detection Zika IgM detection 10

Lab-based EUA tests 2 Lab-based EUA tests Point-of-care rapid test

Awarded $16.6 M BARDA contract THE WALL STREET JOURNAL YOU ARE READING A PREVIEW OF A PAID ARTICLE SUBSCRIBE NOW TO GET CONTENT.

OraQuick Zika Rapid Antibody Test* Point-of-care value Rapid results at patient s side <30 minute read time Relieves Public Health Lab testing burden Prototype* data

In-house testing with prototype design: % positive agreement: 97.3% (36/37) % negative agreement: 98.3% (295/300) Targeting EUA Submission in Q2, 2017 * The OraQuick Zika Rapid Antibody Test is a prototype and not intended

for IVD use. Performance characteristics have not been established

Unique solution for emerging disease Rapid development of high quality tests for outbreak management Robust, flexible & proven platform Strong partnerships and funding 39

Tuberculosis (TB) Cassandra Kelly-Cirino, Ph.D. Vice President, Infectious Disease TB and Emerging Diseases Program Lead DNA Genotek

TB is an ongoing global crisis . TB KILLS 4,900 people per day One person every 18 seconds 1.8 million died in 2015 400,000 people with HIV+TB

28,500 people are infected per day 10.4 million people infected in 2015 Better reporting, diagnosis and access to care will close this gap Source: WHO

WHO s end TB strategy End the global TB epidemic Reduce TB deaths by 90% Cut new cases by 90% between 2015 and 2035 Ensure that no family is burdened with

catastrophic expenses due to TB

Why is TB eradication such a challenge? Easy to catch TB is highly contagious spread through the air, most often by coughing Difficult to reach patients

Poor patient access rural settings with no infrastructure Need to collect, transport and process viable sputum samples Hard to diagnose Inefficient laboratory processes Diagnostic tests for TB are insensitive, slow

and/or expensive Hard to treat Increasing antibiotic resistance

The crisis gap While 6.1 million people had access to quality TB care, 4.3 million missed out in 2016 100M sputum samples were collected to find the 6.1 diagnosed

cases in 2016 ~200M sputum samples are needed to find the 4.3M undiagnosed people Source: WHO

Current sample method challenges Current sample method challenges Sample quality Samples need to be shipped on ice or can be putrefied and unusable when they arrive at the lab

Sample quality directly impacts tests results and diagnosis rates Laboratory inefficiency NaOH/NALC used to liquefy samples Needs to be mixed and quality controlled daily Labor intensive and limits number of samples

tested per day 50,000+ labs spend over 12,500,000 hrs/yr preparing a reagent that we eliminate Failed diagnosis kills Delayed treatment Further spread of disease More lives impacted Photo source: www.dw.com and

Our solution Leader in Biospecimen Optimization A reagent designed to maintain MTb viability for 8 days between 39oF and 104oF while liquefying and decontaminating sputum samples.

IP protected Sample transport and CE/IVD marked decontamination reagent

What OMNIgene SPUTUM solves Eliminate need and cost of cold chain transport Eliminate samples lost due to putrefaction in transit Eliminate daily reagent preparation