Cleveland Diagnostics Announces Publication of Multicenter IsoPSA Clinical Validation Study Demonstrating Improved Accuracy Over Prostate-Specific Antigen Test

IsoPSA technology can reduce unnecessary prostate biopsies

CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a clinical-stage company focused on
developing next-generation diagnostic tests for the detection of
cancers, today announced the online publication of results from a
multicenter validation study of IsoPSA™, a novel structure-based
prostate cancer assay, in Journal of Urology. The study validated
the findings from a preliminary study published earlier in European
Urology, demonstrating that the non-invasive, blood-based IsoPSA
assay has superior diagnostic accuracy over the current gold standard,
prostate-specific antigen (PSA), in detecting high-grade prostate cancer.

The study, led by Eric Klein, M.D., chairman of Cleveland Clinic’s
Glickman Urological & Kidney Institute, involved leading researchers
from Cleveland Clinic, Johns Hopkins, University of Texas Southwestern,
Kaiser Permanente Northwest, Rabin Medical Center (Israel), and other
academic and community clinical sites.

“We now have extensive clinical evidence that supports our technology
and the ability of IsoPSA to meaningfully change the current clinical
paradigm in prostate cancer diagnosis,” said Arnon Chait, Ph.D., CEO of
Cleveland Diagnostics. “We continue to work towards the appropriate
regulatory approvals to get IsoPSA into the hands of physicians as soon
as possible.”

The multicenter study compared the diagnostic accuracy of Cleveland
Diagnostics’ IsoPSA technology to that of PSA, the current standard of
care in prostate cancer, in men scheduled for prostate biopsy. The
results echoed those from a preliminary study, demonstrating that IsoPSA
has much greater diagnostic performance than PSA in identifying which
patients have high-grade disease.

“The superior clinical performance stems from the underlying technology,
which effectively classifies proteins based on cancer-specific changes
to their structure, rather than overall concentration in blood – which
is not cancer-specific. This first-in-class scientific approach can be
extended to a number of cancers and neurodegenerative diseases, which we
are currently exploring,” said Chait. The results of the study show that
IsoPSA could reduce unnecessary biopsies by at least 45 percent, saving
men from unneeded invasive and expensive procedures that can sometimes
lead to serious and lasting side effects. Future indications for IsoPSA
could also include active surveillance and direct replacement of PSA for
screening in the primary care environment, while still maintaining a
similar cost structure.

Cleveland Diagnostics has several clinical collaborations around the
world, including underserved areas in Africa and India. “A unique
advantage of IsoPSA is that it does not require highly specialized or
expensive equipment or reagents to run samples,” said Aimee Kestranek,
Vice President of Operations at Cleveland Diagnostics. “We have set up
clinical sites in a matter of hours due to the ease-of-use of the IsoPSA
technology.”

Dr. Klein has no personal financial interest in the company.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a clinical-stage biotechnology company
developing technology to improve cancer diagnostics. Its Solvent
Interaction Analysis (SIA) technology investigates biomarkers at the
structural level as opposed to overall concentration, giving better
insights as to the protein origin. Its portfolio of non-invasive cancer
diagnostics include prostate cancer, breast cancer, and Alzheimer’s
disease. Visit us at cleveland-diagnostics.com.

Contacts

Cleveland Diagnostics, Inc.
3615 Superior Ave #4407B
Cleveland,
OH 44114
Erich Heise
Phone: 216.432.2700
[email protected]