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OAKLAND UNIVERSITY WILLIAM BEAUMONT
oakland.edu/medicine
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CAPSTONE PROGRAM
Clinical Utility of ConfirmMDx for
Prostate Cancer in Management
of Suspected Prostate Cancer
1Thanh
1Oakland
Huynh, 2Jason Hafron, MD
University William Beaumont School of Medicine
2William Beaumont Department of Urology
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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?
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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?
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Background
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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
biopsy1, 2
One study has shown that ConfirmMDx reduced the rate
of repeat prostate biopsies in clinical practice3
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
Methods
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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
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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)
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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.)
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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.
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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
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Acknowledgements
• Ayad Khourdaji, MD and Jessica Gibson
(MDxHealth)for help with data collection
• MIU Men’s Health Foundation Jeff Murri
Scholarship
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.
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