self testing meeting glasgow reid3

Diagnosing the Undiagnosed. The development of a non invasive, rapid HIV self test

Brian Reid

Vice President, International

OraSure Technologies Inc.

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Reaching the unreachable – novel testing means

Providerbased

HCTCommunity

testing

Home testing

Providerbased

Selfsampling

testing

Supervised

self

InPharmacy

testingtesting

Anonymous

self

Laboratorytesting

•Despite widespread availability of blood tests, significant number of individuals

have never had an HIV test

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• Highly accurate (>99%) test results in 20 minutes

• Sensitivity: 100%* Specificity: 99.8%*

• Over 25 million units sold worldwide

• 30 month shelf life

• Used in diverse settings

OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test

Confidential & Proprietary

Rapid-format test that detects HIV antibodies in oral mucosal transudate (OMT)

OMT contains high concentration of IgG antibodies.

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Oral Fluid – Specimen Collection

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SIMPLE RESULT INTERPRETATION:

One line = NEGATIVE

Two lines = POSITIVE*

OraQuick® In-Home HIV Test- Result Interpretation

Negative

Reactive Control

Line

Positive

Reactive HIV-1/2

Test Line

* Labeling describes positive result as ”you may have HIV”


OraQuick In Home HIV Test History


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Challenges Maximizing Diagnostic Efficiency of Home Tests

• Bastian LA et al. (1998). Meta-analysis of home pregnancy tests:– Sixteen home pregnancy tests (5 studies)– Aggregate sensitivity in laboratory studies: 91%

(84%-96%)– Aggregate sensitivity in self-test studies: 75% (0.64-

0.85)

• De La Fuente et al. (2012). Self-test study using fingerstick HIV test:– Only 92% of users obtained a valid result

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OraQuick In-Home HIV Test System – Outer Box


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Label Comprehension Study Results

Product use (self-selection)

Time test can detect HIV (window period)

What to do if anxious about taking the test

Not okay to use under 14 years of age

Okay to use if pregnant

Not okay if previously diagnosed with HIV

Wait 30 minutes after eating / drinking

Not okay to expose to cleaning reagents

Last step before timing test

Minimum time test result can be read (>20 minutes)

Time when test result is no longer valid (>40 minutes)

What to do if test result is Positive

What to do if you are not sure of your result

What to do if your test result is Negative

What to do if you have any questions

98.8%

98.6%

97.2%

92.8%

91.8%

88.4%

96.2%

91.4%

84.6%

96.4%

98.2%

97.0%

97.4%

82.2%

99.2%

Questions on self-selection Questions on performing the testQuestions on interpretation of the test results


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OraQuick In-Home HIV Test System – Kit Contents

Test stand

Test Device

Pouched Device

Pouched Developer Vial

Stepwise Instructions

Pre & Post-Test Informational Booklet

Package Insert


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Phase III Trial: Unobserved Self-Testing Study

• Visit 1: Subject enrolled and blood drawn for lab testing

• Visit 2: Subject self selected (or de-selected) and took possession of OraQuick In-Home HIV Test kit

• Visit 3: Subject returned to site and provided self-test result according to standard script

– Site staff provided laboratory results to the subject

– Appropriate counseling was provided based on laboratory results

– Additional information collected on subject intent

• Visit 4: Scheduled if required based on follow-up testing

• Cross sectional demographics


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Performance of the In-Home HIV test in the Hands of the Consumer(Phase III Study of Unobserved Self-Testing)

Accuracy(4990/4999)

99.82%(95% CI: 99.66% - 99.92%)

Test System Failure Rate*(56/5055)

1.11% (95% CI: 0.84% - 1.44%)

Sensitivity(88/96)**

91.67%(95% CI: 84.24% - 96.33%)

Specificity(4902/4903)

99.98%(95% CI: 99.89% - 100.0%)

NPV(4902/4910)

99.84%(95% CI: 99.68% – 99.93%)

PPV(88/89)

98.88%(95% CI: 93.90% - 99.97%)

*Proportion of tests that user failed to get a positive or negative result ** Eight HIV positive individuals reported their HIV self-test result as negative


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Intention Responses: HIV Positive Subjects

0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4

Scale of 0 to 4

Pe

rce

nta

ge

Likelihood to get post-test counseling

Likelihood to follow-up with doctor or clinic for treatment

Likelihood to Recommend

Not at all likely Definitely

(N=101)

(N=101)

(N=100)

Source: Phase III studyConfidential & Proprietary

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Intention Responses: HIV Negative Subjects from High Prevalence Sites

0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4

Scale of 0 to 4

Per

cen

tag

e

Likelihood to get tested again for HIV

Likelihood to use a rapid HIV home test

Likelihood to use HIV home test to screen new sexual partners

DefinitelyNot at all likely

(N=3903)

(N=3902)

(N=3901)


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Low Levels of Anxiety Reported Among HIV Positive Subjects Identified During Unobserved Self-test Study

• Of the HIV positive subjects, most (68.6%) were described as “calm” by site staff during counseling and discussion of HIV positive results

• Among HIV-positive subjects, there were no anxiety-related adverse events that required intervention by site staff when HIV positive results were discussed


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Key Findings from Clinical Trial of Unobserved Self-Testing (n= 5055)

• Ninety nine percent (99%) of users successfully obtained a test result (positive or negative)

• Eighty eight (88) subjects of previously unknown status self-identified as HIV positive through use of the in-home test (1.7%)

– Eight HIV positive subjects reported their self-test result as negative to the clinical sites (calculated sensitivity = 88/96= 92%)

• Predictive value of the test was very high (NPV= 99.8%; PPV=98.9%)• Excellent observed specificity (4,902/4,903; >99.9%) • Excellent overall accuracy* (4,990/4999; >99%)• Strong benefit/risk for product approval:

– Predicted number of individuals identified (who otherwise wouldn’t have tested)

– Estimated number of forward transmissions prevented

* Not an FDA approved label claim

Source: Phase III study Confidential & Proprietary

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OraQuick HIV In-Home Support Center

• Designed and developed specifically for use with the OraQuick® In-Home HIV Test • Operational 24/7/365

• Information management system for consistent responses, referral to care & complaint intake

• Designed to allow the caller to remain anonymous

• Scripts and materials were developed in conjunction with representatives with practical counseling experience


OraQuick Phone Queue Goal Queue 1 Test Results 100% answered immediatelyQueue 2 Test Usage 100% within 20 seconds Queue 3 Orders/Inquiries 80% within 30 seconds

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Reported Positive Test Results, Referrals and Consumer Complaints

• ~400 calls per week• 212 callers reported a positive result after using the OraQuick In Home HIV test• 677 callers received referrals

• Reasons for declining a referral include following up with their own HCP or testing facility

• Other reasons for referrals (outside of confirmatory test) include inquiries for free testing, clinics, HIV Specialists, state hotline referrals, additional STD information

• <0.1% complaint rate launch to date576 101 111

Referrals

Positives

Data is sourced from OraQuick Inquiry System and is through September 30,2013 Confidential & Proprietary

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Projection of Positives Identified

Theoretical Projection of Total Number of Positives Identified

Based on Consumer Support Center Activity

212 Positives* Identified via Consumer Support Center

% of Positives Calling Support Center**

1% 5% 10%

Projected Total Number of Positives

21,200 4,240 2,120

Positives as Percent of Units Sold to date

10% 2% 1%

*Positives captured launch through 9/30/13** Based on prelaunch research indicating that most (96%) consumers receiving positive result will contact their healthcare professional; ~200K units sold launch through September 2013

• We believe the prevalence rate with the OTC consumer is between 1-2%• This is consistent with the data generated in the clinical study of a 1.7%

prevalence rate


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Web Site Support: www.OraQuick.com

• Engage• Learn about the OraQuick

Self-Test

• Education• Video tutorials• Warnings and precautions

• Support• Find Counseling and Care

• Sales• Access to Purchase

OraQuick® In-Home HIV Test

1

2

2

2

3 5 4


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National Campaign

• Designed to de-stigmatize testing and drive product awareness

• Launched via Advertising, Public Relations and retail promotion.

“Testing for HIV is Everyone’s Thing”

“Knowing is the Best Thing”


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Un

its

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500

1000

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3500

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4500

5000Total US

Avg Units per Week

OraQuick® Retail Sales Trend

Source: Nielsen data, Oct 2012-Aug 31, 2013

-2%

+48%

+27%

+51%+4%

+11% +1%+2%

+9%

-9%

• Over 200K units sold launch to date

• E-Commerce accounts for an additional 9% in units

-6%


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Core Buyers Emerging

Urban

MSM AA

Single College Towns

Hispanic American

Asian American

Secondary

• Consistent with Expected Source of Volume by Consumer Segment– MSM and AA Estimated to contribute 86% of Volume

Source: Spectra & Experian research data


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Public Health Programs

• Several Public Health and Advocacy groups have purchased OraQuick® In-Home HIV Test kits

• Primary uses in Public Health settings relate to:– Social Networking: Provide tests to high risk individual

to give to other individuals living in high risk communities

– Prevention for Positives: Provide tests to individuals who have tested positive to give to partner(s)

– Missed Testing Opportunities: Provide test to individuals who have declined a test at a clinic, mobile site, event, etc., giving them an opportunity to test at home


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Overall Summary

• OraQuick In Home HIV Test approved in July 2012– Approval driven by strong risk/benefit argument

• Consumer support resources to maximize linkage to health services and providers; system functioning extremely well

• Product up take continuing to build, as awareness builds among high risk populations

• Believed to be providing substantial public health benefit in terms of number of positives identified

self testing meeting glasgow reid3

Health & Medicine

phase iii

test study

confidential

test result

aggregate

site staff

hiv

test