PENK

EarlyTect BCD test is a non-invasive, urine-based diagnosis intended to become a new diagnostic option for patients suspected of having bladder cancer FDA grants breakthrough device designation to EarlyTect BCD test. (Credit: FDA grants breakthrough device designation to EarlyTect BCD test) Promis Diagnostics has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for its EarlyTect BCD test for the detection of bladder cancer in patients with hematuria. EarlyTect BCD test is a non-invasive, urine-based diagnosis. It is intended to qualitatively recognise PENK methylation, which is a single epigenetic biomarker related to bladder cancer in the urine DNA of patients having hematuria. Bladder cancer is considered to be one of the most prevailing cancers in the US and its most common sign is hematuria. Methylation of PENK is considered to be present very frequently in the urine DNA of all bladder cancer patients. However, it is rarely or not at all found in patients with hematuria without bladder cancer. Promis Diagnostics CEO Sungwhan An said: “We are very excited about this FDA’s Breakthrough Device Designation grant to the EarlyTect BCD. It is a testament to our relentless commitment to developing an effective diagnostic test. “EarlyTect BCD would provide a meaningful improvement in non-invasive diagnostics addressing unmet needs of catching primary cancer early in the initial diagnosis. Consequently, it will improve patient outcomes.” The FDA’s breakthrough device designation helps accelerate the review of new technologies that can enhance the lives of patients having life-threatening or conditions that are irreversibly debilitating. Promis Diagnostics business strategy and operations head Justin Lee said: “We look forward to working with the FDA to accelerate the approval process and to get EarlyTect BCD into the hands of patients and healthcare providers faster.” Based in Irvine, California, Promis Diagnostics is a specialised laboratory, which has developed a technology called LTE-qMSP designed for the early detection of colorectal, bladder, and lung cancer by using methylated DNA as biomarkers.

With Breakthrough Device Designation, EarlyTect BCD could become available as a new diagnostic option sooner for people suspected of having bladder cancer IRVINE, Calif., April 28, 2023 /PRNewswire/ -- Promis Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to EarlyTect BCD as a non-invasive, urine-based diagnosis of bladder cancer from patients with hematuria. Continue Reading In the United States, bladder cancer is the 6th most common cancer and the tenth leading cause of cancer death in 2023. The most common sign of bladder cancer is hematuria. However, about 10 percent of visible hematuria patients and only 2 to 5 percent with microscopic hematuria are diagnosed with bladder cancer. Promis Diagnostics' EarlyTect BCD Receives FDA Breakthrough Device Designation for Bladder Cancer Detection Tweet this The EarlyTect BCD test is intended for qualitatively detecting a single epigenetic biomarker, PENK methylation, associated with bladder cancer in the urine DNA from patients with hematuria. Methylation of PENK is known to present highly frequently in the urine DNA of all patients with bladder cancers, while rarely or not at all in hematuria patients without the disease. "We are very excited about this FDA's Breakthrough Device Designation grant to the EarlyTect BCD. It is a testament to our relentless commitment to developing an effective diagnostic test. EarlyTect BCD would provide a meaningful improvement in non-invasive diagnostics addressing unmet needs of catching primary cancer early in the initial diagnosis. Consequently, it will improve patient outcomes.," said Sungwhan An, Ph.D., CEO. Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions. To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment, and review while maintaining regulatory standards for pre-market approval. "We look forward to working with the FDA to accelerate the approval process and to get EarlyTect BCD into the hands of patients and healthcare providers faster," said Justin Lee, Head of Business Strategy & Operations. About Promis Diagnostics Promis Diagnostics is a fully licensed and accredited specialized laboratory headquartered in Irvine, CA. We were founded to enable patients to lead healthier lives by providing actionable and affordable cancer early diagnostics options. Our product pipeline includes non-invasive colorectal, bladder, and lung cancer diagnostic tests. Our specialization is discovering DNA methylation biomarkers and developing highly effective body fluidic-based cancer detection methods. We hold the highest standards of quality control and assurance. We are accredited by the College of American Pathologists (CAP) and certified through Clinical Laboratory Improvement Amendments (CLIA). We operate a state-of-the-art molecular laboratory providing cancer diagnostics. We are dedicated to consistently delivering high-quality services. We will be attending the upcoming 2023 American Urological Association (AUA 2023) annual conference in Chicago, IL. Connect with us at SOURCE Promis Dx

PenKid identified as a promising kidney function biomarker to support future precision medicine approaches for RRT-dependent AKI. A post-hoc analysis of the ELAIN trial indicates that penKid could enable the assessment of kidney function under RRT and guide early and successful liberation of treatment. For the risk stratification of AKI patients, penKid may be a useful biomarker in identifying the need for timely RRT initiation. HENNIGSDORF, GERMANY / ACCESSWIRE / December 15, 2022 / The diagnostic company SphingoTec GmbH (SphingoTec) announces first data on the kidney function biomarker penKid as a promising tool in supporting early initiation and liberation from RRT (1). Although RRT remains a pivotal measure in treating AKI complications, it is also associated with significant risks and its duration should be restricted to a minimum. The current findings show that penKid has the potential to reveal unprecedented insights on the underlying kidney function prior and during ongoing RRT, facilitating an early and successful termination of treatment. This may support timely risk stratification and individualization of treatment pathways. To allow kidney recovery in critically ill patients with AKI, RRT remains the key rescue therapy. However, no precise prediction tools are currently available to determine RRT liberation, although 5 - 13% of AKI patients have a high need for RRT (2,3). Due to scarcely available options, discontinuation of RRT relies on expert-based recommendations or clinical judgment based on controversial indications such as urine output. And yet, early discontinuation of RRT would not only be beneficial for the patient but also support the allocation of limited intensive care resources, thereby helping to reduce costs of unnecessarily long periods of RRT or unsuccessful termination with subsequent need for re-initiation of RRT (4). The current analysis has demonstrated that penKid could be a competent marker to monitor kidney function during ongoing RRT (1). Low penKid values during RRT were associated with earlier and successful liberation from RRT, compared to the group presenting high penKid levels. As a consequence, penKid could support clinicians identify those patients with sufficient kidney recovery, suitable for RRT liberation. In addition, at the time point of AKI diagnosis, measuring penKid values could allow the identification of patients who may benefit from early RRT initiation. Supplementary data suggest that prompt intervention may result in shorter RRT duration. The results of this study are complemented by previous scientific evidence showing that penKid mirrors real-time glomerular filtration rate (GFR) even in non-stable settings (5). Furthermore, penKid is unaffected by non-renal factors such as inflammation, common comorbidities, and gender (6,7,8), making it a suitable biomarker, especially for critically ill patients. Deborah Bergmann, Director of Marketing and Sales at SphingoTec commented, "The implications of the current findings are of great significance for future individualized approaches in managing RRT-dependent AKI. For the first time, scientists identified a biomarker that has the potential to shed light on clinically hidden developments in patients undergoing RRT, a highly challenging stage. This may benefit patients' health on short and long term, as well as support healthcare providers reduce costs and better assign resources." ## References: von Groote T et al. Proenkephalin A 119-159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). Hoste EA, Bagshaw SM, Bellomo R, et al. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med 2015;41:1411-23. Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, et al. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005;294:813-8. Korkeila M, Ruokonen E, Takala J. Costs of care, long-term prognosis and quality of life in patients requiring renal replacement therapy during intensive care. Intensive Care Med. 2000;26:1824-1831. Beunders R, van Groenendael R, Leijte G, Kox M, Pickkers P. Proenkephalin compared to conventional methods to assess kidney function in critically ill sepsis patients. Shock. 2020 Jan;1 Beunders et al. (2017), Proenkephalin (PENK) as a novel biomarker for kidney function, JALM, DOI: 10.1373/jalm.2017.023598 Caironi P, Latini R, Struck J, Hartmann O, Bergmann A, Bellato V, et al. Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem. 2018;64((9)):1361-9. Donato LJ, Meeusen JW, Lieske JC, Bergmann D, Sparwaßer A, Jaffe AS. Analytical performance of an immunoassay to measure proenkephalin. Clin Biochem. 2018 Aug;58:72-7. About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. Sphingotec's innovative markers are made available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for assessment of endothelial function in conditions like sepsis, and Proenkephalin A 119-159 (penKid), a biomarker for assessment of kidney function in critical diseases. About penKid Proenkephalin A 119-159 (penKid) is a blood-based biomarker for assessing the kidney function in acute and critical conditions. The biomarker offers a blood-based alternative for the complex and time-consuming in vivo measurement of true glomerular filtration rate (GFR). PenKid is independent of common comorbidities (e.g. hypertension and diabetes) and the frequently occurring inflammation in critically ill patients. Rising penKid blood levels predict acute kidney injury earlier than today's standard of care and decreasing penKid blood levels indicate the improvement of kidney function. Scientific evidence shows that penKid also reflects kidney function in children, representing a potential biomarker for pediatric AKI. Media contact: Ruxandra Lenz Head of Marketing and Communication SphingoTec GmbH Neuendorfstr. 15 A 16761 Hennigsdorf Tel. +49-3302-20565-0 SOURCE: SphingoTec GmbH View source version on accesswire.com: