# Presentation: 374469

## OraSure Technologies, Inc.Diagnostic Solutions for the New Millennium

- OraQuick® *ADVANCE**TM** * Histofreezer®  OraSure®  Intercept®

**Update on OraQuick****® *****ADVANCE*****TM Performance**March 2006

## OraQuick® ADVANCETM Performance

- Background
- National performance assessment
- Investigations into reported false positives
- Results from investigations
- Summary

## Background

- In Fall 2005, specific sites in San Francisco and New York City, and the LA Gay and Lesbian Center reported levels of false positive results using OraQuick ADVANCE with oral fluid that were higher than expected
- Immediately after receiving these reports, initiated a systematic scientific evaluation

**Notes:**
I rephrased the bullets a little, and took off the sub-bullets that you just presented on the previous slide – perhaps you preferred the repetition.
On subsequent slides, I made comments in the Notes section but did not change the slides.

## Two Data Sources:
Aggregate national performance in 2005 assessed using data provided by state, city health agencies, HIV/AIDS service organizations:
	Data from 11 states representing 127,323 oral fluid tests
			Overall specificity: 99.8%

OraSure customer survey of product performance in 2005:
	Data obtained from 90 customer testing sites – 43,321 oral fluid tests
			Overall specificity = 99.8%

- Aggregate national performance in 2005 assessed using data provided by state, city health agencies, HIV/AIDS service organizations:
- 	Data from 11 states representing 127,323 oral fluid tests
- 			Overall specificity: 99.8%
- OraSure customer survey of product performance in 2005:
- 	Data obtained from 90 customer testing sites – 43,321 oral fluid tests
- 			Overall specificity = 99.8%

**Overall, actual field performance corresponded to product claim **

- National Performance Assessment

**Notes:**
I would call this “State Analysis”.  They’re not estimates if you collected the data.
What time period do these reports cover?

## National Performance Assessment

***Customer Survey***

*Extremely Satisfied *
*Very Satisfied*
*Satisfied*
*Dissatisfied *

## Investigation into Reports of False Positive Results at Particular Sites

**Process**
- Extensive use of statistical analyses to identify any site with performance outside of expected range
- Carried out visits to affected sites
- Clarify any data discrepancies
- Execute performance panels
- Observe the entire testing process and note any procedural deviations
- Correct any issues observed
- Carried out extensive internal investigation of product manufacturing
- Executed experimental studies to try to determine mechanism by which the false positives were generated at affected sites

**Notes:**
I would change “Process” to “Methods”

## Results 
Statistical analysis of customer site data (130 sites) indicated that only a small number of sites demonstrated specificity below expected levels
Product lots that were used at affected sites were also used in the same region and in other parts of the country with satisfactory performance
Data suggested site-specific factor(s) were affecting performance

- Statistical analysis of customer site data (130 sites) indicated that only a small number of sites demonstrated specificity below expected levels
- Product lots that were used at affected sites were also used in the same region and in other parts of the country with satisfactory performance
- Data suggested site-specific factor(s) were affecting performance

- Investigation into Reports of False Positive Results at Particular Sites

**Notes:**
Instead of statistical analysis, I would say “Statistical Process Control (QC) charts” indicated...

## Internal Investigations of Product  and Manufacturing Process

- No overt process shifts or changes in release or acceptance criteria
- Review of batch records of implicated lots have not identified any significant deviations
- No correlation between false positive reports and product shelf life

## Investigation into Causes of False Positives in the Field

- Experimental studies indicate that substantial over-collection            (e.g. swabbing gums 4 times) can generate false positive results
- Exact mechanism of action is under study
- Contribution of this procedural error to the occurrence of reported false positives is unknown at this time
- OraSure continues to emphasize the importance of correct sample collection
- Continue to work with any sites reporting unsatisfactory performance as part of our routine product support
- Ongoing monitoring of performance at sites
- Investigating any usage/patient-specific factors that may affect performance

## Summary

- Large body of data shows that the product is performing to claims on a national basis
- Extensive analysis of customer performance data indicates that a very small proportion of sites experienced atypical false positive rates
- Extensive investigation and auditing of internal manufacturing processes have identified no deficiencies associated with the false positive reports
- Current information suggests that a site-dependent factor may have contributed to the reduced specificity reported at the affected sites
- Experimental studies have shown that substantial over-collection can cause false positives though the contribution of this to the occurrence of the reported false positives is unknown at this time.
- Some of the previously affected sites are now generating performance consistent with claims
- OraSure is continuing to monitor performance and work with any site reporting unsatisfactory performance as part of routine product support

**Notes:**
Not sure about “highly atypical.”  How about “atypical and site-specific”
- Audits of internal manufacturing processes have identified no irregularities associated with... 
- Current conclusions suggest that site-specific factors may have contributed to the isolated reports.  We are further investigating whether over-collection may play a role.

## OraSure Technologies, Inc.Diagnostic Solutions for the New Millennium

- OraQuick® *ADVANCE**TM** * Histofreezer®  OraSure®  Intercept®

**Thank You**