Promis Diagnostics, Inc. is proud to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to EarlyTect BCD, an innovative and non-invasive urine-based diagnostic tool for bladder cancer in patients presenting with hematuria. This breakthrough technology promises to revolutionize the diagnosis of bladder cancer and provide a more convenient, accurate and timely solution to those in need.
In 2023, bladder cancer is set to become the tenth leading cause of cancer death in the United States, making it the sixth most common cancer. The most common sign of bladder cancer is hematuria, with about 10 percent of visible hematuria patients and 2 to 5 percent of microscopic hematuria patients being diagnosed with bladder cancer. It is important to be aware of the signs and symptoms of this potentially deadly cancer.
The EarlyTect BCD test is an innovative epigenetic marker test designed to qualitatively detect PENK methylation in the urine DNA of hematuria patients – a biomarker associated with bladder cancer. This test has been found to be highly sensitive in detecting abnormal levels of PENK methylation in patients with bladder cancer, while remaining rarely present or absent in those without the disease.
We are thrilled to announce that the FDA has granted our EarlyTect BCD a Breakthrough Device Designation! This is a testament to our dedication to developing a revolutionary diagnostic test that will revolutionize non-invasive diagnostics, providing an effective means of detecting primary cancer early in the diagnosis process. By doing so, we are confident that we will improve patient outcomes and make a real difference in people’s lives.
Breakthrough Device Designation is an initiative that accelerates the development and review of cutting-edge technologies that can revolutionize the lives of people living with life-threatening or irreversibly debilitating diseases or conditions.
By offering an expedited pathway for these innovative treatments, patients and clinicians can gain timely access to these breakthroughs, without compromising the safety standards for pre-market approval. With this program, we are striving to provide more effective care and treatments for those affected by life-threatening diseases and irreversibly debilitating conditions.
We are excited to collaborate with the FDA and to expedite the approval process of EarlyTect BCD, in order to make it available to patients and healthcare providers as soon as possible. Justin Lee, Head of Business Strategy & Operations, is eager to make this happen and is committed to helping make a difference.
About Promis Diagnostics
Promis Diagnostics is revolutionizing the way cancer is detected, treated and ultimately cured. Our state-of-the-art, accredited and certified molecular laboratory based in Irvine, CA is dedicated to providing actionable and affordable solutions for early detection of colorectal, bladder and lung cancers.
Our experienced team of professionals are committed to maintaining the highest standards of quality control and assurance, and our cutting-edge product pipeline includes non-invasive DNA methylation biomarkers and body fluidic-based cancer detection methods. We strive to enable patients to lead healthier lives with our innovative diagnostic tests.
We are excited to be a part of the 2023 American Urological Association (AUA 2023) annual conference in Chicago, IL. This year’s event promises to be an incredible opportunity to learn from leading professionals in the field, network with peers, and explore the latest developments in urology. Don’t miss out on this amazing experience – join us as we make our way to the Windy City!