1. CAPSTONE PROGRAM 1 OAKLAND UNIVERSITY WILLIAM BEAUMONT oakland.edu/medicine 1

2. Clinical Utility of ConfirmMDx for Prostate Cancer in Management of Suspected Prostate Cancer 1 Thanh Huynh, 2 Jason Hafron, MD 1 Oakland University William Beaumont School of Medicine 2 William Beaumont Department of Urology 2 Title Slide Project Title - Should be short and descriptive (12 words or less and no acronyms) Subtitles Your Name Additional names of authors with degrees Place a comma between author’s names Authorship indicates involvement in all 3 of these areas: 1.the study design 2.data collection and analysis 3.writing and editing any presentation Affiliations Name of Department, Institution, etc. All authors and their affiliations should be recognized. Title Slide Project Title - Should be short and descriptive (12 words or less and no acronyms) Subtitles Your Name Additional names of authors with degrees Place a comma between author’s names Authorship indicates involvement in all 3 of these areas: 1.the study design 2.data collection and analysis 3.writing and editing any presentation Affiliations Name of Department, Institution, etc. All authors and their affiliations should be recognized. Please feel free to change slide titles, add graphics, and add slides as needed to individualize your presentation to your research!

3. What is the clinical utility of the ConfirmMDx Test for Prostate Cancer, i.e. do the results of the test change frequency of repeat biopsies, follow-up visits, and prostate-specific antigen tests? 3 Hypothesis or Research Question This will allow the audience to orient themselves to the purpose of your work. Try to make this a single sentence. You will be referring to this on your discussion and conclusions slide Hypothesis or Research Question This will allow the audience to orient themselves to the purpose of your work. Try to make this a single sentence. You will be referring to this on your discussion and conclusions slide

4. Introduction Prostate cancer is one of the most common cancers in men Prostate-specific antigen tests (PSA), digital rectal exams (DRE), and prostate biopsies are methods of screening and detection ConfirmMDx (MDxHealth, Inc, Irvine CA) is an epigenetic assay that helps confirm negative biopsy. Will ConfirmMDx results decrease future clinical tests? 4 Introduction Provide a brief introduction to your topic here including information on why you chose this topic Be very succinct and guide the reader to the primary focus of the study building off of the hypothesis. Bullet points are best – don’t cut and paste a paragraph into the slide Brief study objectives or specific aims may be included. Introduction Provide a brief introduction to your topic here including information on why you chose this topic Be very succinct and guide the reader to the primary focus of the study building off of the hypothesis. Bullet points are best – don’t cut and paste a paragraph into the slide Brief study objectives or specific aims may be included.

5. Background ConfirmMDx for Prostate Cancer is a relatively new test, having come out in May 2012 Several studies have shown the effectiveness of using epigenetic assays to detect prostate cancer not seen on biopsy 1, 2 One study has shown that ConfirmMDx reduced the rate of repeat prostate biopsies in clinical practice 3 Since ConfirmMDx is a new test, more studies are needed to confirm its clinical utility. Want to look at other parameters other than biopsies, such as repeat office visits and PSAs to see if test has clinical utility 4 Background Brief background for your topic - including what you have found in the literature. Use in text citations if applicable (from reference slide) Bullet points are best Your audience may know very little about your topic and what has been done previously. State what is new and different about your project, including rationale for doing this study. Include images/graphics if appropriate Background Brief background for your topic - including what you have found in the literature. Use in text citations if applicable (from reference slide) Bullet points are best Your audience may know very little about your topic and what has been done previously. State what is new and different about your project, including rationale for doing this study. Include images/graphics if appropriate

6. Methods Retrospective chart review. Compare 3 different populations using data collected from charts of patients at the Michigan Institute of Urology: 1) control group with negative biopsies and no ConfirmMDx test 2) negative biopsies with negative ConfirmMDx tests 3) positive biopsies with positive ConfirmMDx tests Compare differences between the groups in terms of follow-up visits, biopsies, and PSAs 4 Methods Use bullet points Include sufficient information such that the audience can reasonably understand what is proposed or what work has already done. Use in text citations if applicable (from reference slide) Include graphics/images/flowchart if possible Methods Use bullet points Include sufficient information such that the audience can reasonably understand what is proposed or what work has already done. Use in text citations if applicable (from reference slide) Include graphics/images/flowchart if possible

7. Methods Tools/Forms of Analysis Use statistical tests to compare treatment in the three groups Sample size limited due to the number of patients/charts available to analyze Collecting demographic data (age, race, BMI, family history) and clinical data (DRE, PSA, biopsy findings and their dates) 4 Methods con’t Use bullet points Describe your survey tools, instruments, method of analysis, etc. Specifically include the study design, population of interest, sample size and rationale for the sample size. Describe any intervention, observations, data collection tools and forms of analysis. Graphs, tables or images would be appropriate here. Methods con’t Use bullet points Describe your survey tools, instruments, method of analysis, etc. Specifically include the study design, population of interest, sample size and rationale for the sample size. Describe any intervention, observations, data collection tools and forms of analysis. Graphs, tables or images would be appropriate here.

8. Challenges/Solutions/Limitations Small sample size (~50-100 patients per group) may not be enough data to prove trends in physician behavior Using data from one source (Michigan Institute of Urology) Limited follow-up times Ideally, all three groups would be matched for the main risk factors (e.g. age, race, PSA at biopsy, etc.) 4 Challenges/Solutions Use bullet points Describe any challenges that you have encountered and any related solutions you have found. Describe any limitations to the study. Challenges/Solutions Use bullet points Describe any challenges that you have encountered and any related solutions you have found. Describe any limitations to the study.

9. Results Results pending Hope to find that ConfirmMDx increases clinical by decreasing the number of follow-up visits, prostate specific antigen tests, and prostate biopsies. 4 Results Use bullet points Summarize your results Indicate your forms of analysis Use Graphs, Tables or images Add additional slides if needed to highlight data/results Results Use bullet points Summarize your results Indicate your forms of analysis Use Graphs, Tables or images Add additional slides if needed to highlight data/results

10. Concluding Remarks and Discussion Most of data has been collected and hoping to perform analysis soon ConfirmMDx test could help reduce the number of clinical tests done after biopsy, preventing repeat testing and saving money Future work could include larger sample sizes with better matching between groups, and more follow-up time 4 Concluding Remarks and Discussion Use bullet points Present any data you may have or points for discussion you would like to bring up to the audience Reflect back on how your conclusions address your hypothesis or research question Highlight the implications of your work. How will your work potentially contribute to the current body of knowledge? Describe any future questions/studies that could develop from your work Concluding Remarks and Discussion Use bullet points Present any data you may have or points for discussion you would like to bring up to the audience Reflect back on how your conclusions address your hypothesis or research question Highlight the implications of your work. How will your work potentially contribute to the current body of knowledge? Describe any future questions/studies that could develop from your work

11. Ayad Khourdaji, MD and Jessica Gibson (MDxHealth)for help with data collection MIU Men’s Health Foundation Jeff Murri Scholarship Acknowledgements This is where you should mention anyone who does not meet all three criteria of authorship Community Partners should be included Statisticians can be included Sources and grant numbers need to be listed here. Acknowledgements This is where you should mention anyone who does not meet all three criteria of authorship Community Partners should be included Statisticians can be included Sources and grant numbers need to be listed here.

12. References 1. Stewart G, Van Neste L, Delvenne P, et al. Clinical utility of a multiplexed epigenetic gene assay to detect occult cancer in histopathologically negative prostate biopsies: results of the multicenter MATLOC study. J Urol. 2013; 189: 1110-16. 2. Van Neste L, Herman JG, Otto G, et al. The epigenetic promise for prostate cancer diagnosis. Prostate. 2012; 72: 1248-1261. 3. Wojno KJ, Costa FJ, Cornell RJ, et al. Reduced rate of biopsies observed in ConfirmMDx clinical utility field study. Am Health Drug Benefits. 2014; 7(3): 129-134. 4 References Using AMA formatting, list the most relevant references from your literature search pertaining to your presentation. Be sure to use in-text citations from this list throughout your presentation where applicable References Using AMA formatting, list the most relevant references from your literature search pertaining to your presentation. Be sure to use in-text citations from this list throughout your presentation where applicable

13. 13 Thank you and Questions Thank the audience for attending and for their attention Ask for any questions if time permits Thank you and Questions Thank the audience for attending and for their attention Ask for any questions if time permits