Waltham, MA – May 8, 2018 – Exosome Diagnostics, Inc. has expanded its urology salesforce within the United States after a successful first quarter commercial launch of ExoDx Prostate®(IntelliScore) (EPI). EPI is the world’s first exosome based diagnostic test, and has been proven in multiple prospective clinical trials to reduce a significant number of unnecessary prostate biopsies for patients within the PSA grey zone of 2-10ng/ml.

EPI is an easy-to-use molecular test that offers actionable clinical results when making prostate biopsy decisions. While the issues inherent with PSA testing have traditionally made sending the correct patients to prostate biopsy challenging, EPI has offered clinicians a non-PSA based molecular option that helps to rule-out patients at low risk for high-grade prostate cancer from the biopsy process. 

“We are thrilled with the outstanding progress our commercial team has made this past quarter. EPI is a clear standout in this space, showcasing unmatched clinical data and earning unprecedented reimbursement wins. Our urology sales force has done a tremendous job capitalizing on these opportunities.” stated Elizabeth Cormier-May, VP & Head of Commercial Diagnostics. “Just in the last month, thousands of patients have received EPI results through the sales team’s hard work, making the expansion of this organization a top priority for the company,” Cormier-May continued. 

“Exosome Diagnostics remains one of the very few companies that is growing within the molecular diagnostics, prostate cancer market,” stated John Boyce, President and CEO of Exosome Diagnostics. “The volume of EPI patient samples are on a run rate that have necessitated the company to remove all of its predetermined phase gates and expand its sales force in order to deliver the benefits of the test to patients across the country,” Boyce continued. “The company has brought on, and continues to hire, a team of dynamic individuals that will grow the company and provide the next level of management over the years.”

Exosome Diagnostics will be exhibiting at the AUA conference in San Francisco on May 18th-21st. If you are interested in learning more about Exosome Diagnostics’ unparalleled technology and EPI’s supreme data, please visit booth 6452. 

About the EPI Test

The EPI test is a completely non-invasive, urine-based test designed to be used along with clinical assessment and other standard of care factors (including age, race and family history) to enable physicians to assess whether an individual patient presenting for an initial biopsy is at greater risk for high-grade prostate cancer. As a “rule out” test, it is designed to more accurately predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer and, thus, could potentially avoid the discomfort, complications and cost of an initial biopsy and, instead, continue to be monitored. EPI, which is intended for use in men 50 years or older with a prostate-specific antigen (PSA) result of 2-10ng/mL presenting for an initial biopsy, involves patients submitting a simple urine sample, without having to first undergo a digital rectal exam (DRE).

This test was evaluated and its performance characteristics determined by Exosome Diagnostics Inc. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) act of 1988 as qualified to perform high complexity clinical testing.

About Exosome Diagnostics

Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. The company’s novel exosome-based technology platform, ExoLution™, and point of care instrument for protein capture and analysis, Shahky™, can yield comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are diagnosed, treated and monitored.

Visit http://www.exosomedx.com to learn more.

Contact

David Clair, Investor Relations

(646) 277-1266 

David.Clair@Bio-Techne.com