Cleveland’s IsoPSA® IVD kit received FDA approval

Announcement

Cleveland Diagnostics, Inc., an advanced commercial-level precision oncology company, proudly shared its FDA approval news for its IsoPSA® in vitro diagnostic (IVD) kit via the Premarket Approval (PMA) process. The IsoPSA is a blood-related test referred to as an aid in the decision for prostate biopsy for men above 50 years with accelerated PSA levels.

The PhD, CEO and President of Cleveland, Arnon Chait, said, “This FDA approval for our IsoPSA kit represents a noteworthy milestone in the company’s mission to support patients and physicians by helping them detect cancer early when it's in a position to be survived and treated. We stay focused on implementing our marketing strategy and extending the access to IsoPSA for the best benefit of the patients globally.”

Reason for IsoPSA approval

The FDA approval of the IsoPSA test was related to the clinical proven from the prominent prospective study held at 14 sites throughout the U.S., and following this study, the data from the supportive analytical validation studies were also said to be convincing. As is known, prostate cancer is one of the common cancers found in the American men population, with 1 in 8 men diagnosed once in their lifetime.

The U.S. has reported that above 1 million men go through prostate biopsies every year, and around 75% individuals’ follow-up tests are adverse enough to meet high-grade disease. This massive gap highlights the expensive invasive procedures that carry the risk of developing emotional stress, noteworthy healthcare costs and physical risk. Learning this, the IsoPSA is the ideal one to fill this gap by providing patients and clinicians with a more precise risk evaluation and motivation in biopsy decision-making.

The Director and Chief Medical Officer of Clinical Research at Associated Urological Specialists in Chicago, Dr Aaron Berger, said, “Been a practising urologist, I first considered looking into how the limitations of the latest PSA testing can bring anxiety and unnecessary procedures stress for patients and applaud the crucial need for precise and early risk evaluation and testing.”

Berger added, “IsoPSA stands as a significant advancement that is offering physicians a tool that will enhance the risk evaluation and will make a valuable contribution to us as well to make informed biopsy decisions with more confidence.”

The Emeritus Chair of the Glickman Urological and Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc., Dr Eric Klein, also expressed his thoughts on this FDA approval, calling it a clinical and valuable utility of the IsoPSA.