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IsoPSA is said to be a blood-based prostate cancer test that is used to triage patients at risk for high-grade prostate cancer to biopsy IsoPSA is a non-invasive, blood-based prostate cancer test. (Credit: CDC on Unsplash) Biotechnology firm Cleveland Diagnostics has partnered with US-based Quest Diagnostics to expand patient access to its IsoPSA prostate cancer test. The US-based Cleveland has designed the IsoPSA as a non-invasive, blood-based prostate cancer test to triage patients at risk for high-grade prostate cancer to biopsy. Under the agreement, patients will be able to access IsoPSA and, following a doctor’s order, provide a blood sample for testing at any Quest Diagnostics patient service centre across the country later this year. Quest Diagnostics, which has more than 2,100 centres in the US, will deliver the specimens to Cleveland Diagnostics’ facility for testing . Both parties anticipate that in the second quarter of 2023, doctors will be able to start recommending the test to patients through Quest Diagnostics. According to the biotechnology firm, IsoPSA offers extra information on whether the patient’s elevated prostate-specific antigen (PSA) levels are caused by high-grade cancer or another ailment. It thus enables doctors and patients to make decisions about whether to have a prostate biopsy. Cleveland Diagnostics CEO Arnon Chait said: “We are very pleased to collaborate with Quest Diagnostics to expand patient access to IsoPSA. We believe Quest’s broad reach and extensive laboratory services expertise will provide patients and their physicians with unparalleled access to transformative clinical insights. “As the leader in oncology testing, Quest is aligned with Cleveland Diagnostics’ vision of providing physicians and their patients exceptional and more definitive understanding of their prostate conditions.” Cleveland said that the IsoPSA test aids in the risk prediction of prostate cancer by examining the partitioning behaviour of PSA isoforms linked to cancer. The test indicated a considerable improvement in detecting high-grade prostate cancer in a sizable, prospective, multicentre clinical investigation. Additionally, it reduced needless biopsies by 55% in a separate study.

CLEVELAND--(BUSINESS WIRE)-- Cleveland Diagnostics Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, today announced an agreement designed to expand patient access to Cleveland Diagnostics’ novel prostate cancer test, IsoPSA. Through an agreement with Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, patients will be able to access IsoPSA and, once ordered by their physician, provide a blood specimen for testing at one of over 2,100 Quest Diagnostics patient service center locations nationwide later this year. With its national logistics network, Quest will transport the specimens to Cleveland Diagnostics’ laboratory for testing. The parties expect physicians will be able to begin offering the test to patients through Quest Diagnostics in the second quarter of 2023. IsoPSA is a blood-based prostate cancer test used in triaging patients at risk for high-grade prostate cancer to biopsy. For patients with elevated levels of prostate-specific antigen (PSA), IsoPSA provides additional insight into whether patients’ elevated PSA levels are due to high-grade cancer or a different condition, thereby empowering physicians and patients with insights for deciding whether to undergo prostate biopsy. PSA is a protein produced by cells of the prostate gland. While the PSA test measures the level of PSA in the blood, which is often elevated in people with prostate cancer, several benign conditions can also cause a person’s PSA level to rise.1 Moreover, PSA testing is unable to identify cases of prostate cancer that may be rapidly progressing and therefore require urgent treatment. By comparison, the IsoPSA test helps predict risk by interrogating the partitioning behavior of isoforms of PSA that are linked to cancer. In a large, prospective, multi-center clinical study, the IsoPSA test demonstrated significant improvement in detecting high grade prostate cancer.2 A separate and robust clinical utility study confirmed that IsoPSA could reduce unnecessary biopsies by as much as 55%.3 “We are very pleased to collaborate with Quest Diagnostics to expand patient access to IsoPSA. We believe Quest’s broad reach and extensive laboratory services expertise will provide patients and their physicians with unparalleled access to transformative clinical insights,” said Arnon Chait, CEO of Cleveland Diagnostics. “As the leader in oncology testing, Quest is aligned with Cleveland Diagnostics’ vision of providing physicians and their patients exceptional and more definitive understanding of their prostate conditions.” “Prostate cancer is a leading cause of cancer – and cancer deaths – among men, and physicians are eager for improved tools to diagnose, stage and monitor this disease,” said Kristie Dolan, vice president and general manager of Oncology at Quest Diagnostics. “We believe IsoPSA holds great promise to better inform physicians’ diagnostic and treatment decisions for their patients being evaluated for prostate cancer, and we are pleased to work with Cleveland Diagnostics to expand access to this important new test, ultimately bettering patient outcomes by improving the diagnostic process.” According to the American Cancer Society, prostate cancer increased by 3% per year from 2014 through 2019 after two decades of decline, driven primarily by the diagnosis of advanced disease.4 A recent Quest Diagnostics Health Trends® study suggests this trend could continue or even worsen: two years after the COVID-19 pandemic began, the rate of new diagnoses of prostate cancer continued to lag behind pre-pandemic levels, suggesting delays in care may contribute to more advanced prostate cancers in the future. About IsoPSA IsoPSA is a non-invasive, blood-based test that demonstrated in a large, multicenter study superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer diagnosis. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test conducted at its high-complexity, CLIA-certified, CAP-accredited laboratory in Cleveland, Ohio. For the time being, tests ordered through the Quest network will be processed in Cleveland Diagnostics’ laboratory in Cleveland, OH. About Cleveland Diagnostics, Inc. Cleveland Diagnostics, Inc. is a commercial-stage biotechnology company developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. The Company’s Solvent Interaction Analysis™ (SIA) technology investigates protein biomarkers at the structural level (as opposed to mere biomarker concentration) in blood, providing better and more direct insights regarding the protein origin on the cellular level, thus improving test specificity to the underlying disease process. Cleveland Diagnostics’ portfolio of non-invasive cancer diagnostics will be expanding from prostate cancer to breast cancer and lung cancer, and certain other diseases. Please visit us at ClevelandDx.com. 1 Prostate-Specific Antigen (PSA) Test - NCI (cancer.gov) 2 Klein E, Partin A, Lotan Y, et al. Clinical validation of IsoPSA, a single parameter, structure-focused assay for improved detection of prostate cancer: A prospective, multicenter study. Urol. Oncol. 2022; 40(9): 408.e9-408e.18 3 Scovell JM, Hettel D, Abouassaly A, et al. IsoPSA® reduces recommendations for biopsy and magnetic resonance imaging in men with total PSA ≥ 4ng/ml: A real-world observational clinical utility study. Urol Pract. 2022; 9:173. 4 More men diagnosed with advanced prostate cancer as PSA testing drops (nbcnews.com)

CGS Administrators, Inc., the Medicare Administrative Contractor with jurisdiction over Cleveland Diagnostics, issues final Local Coverage Decision (LCD) providing coverage of the IsoPSA prostate cancer test for Medicare beneficiaries nationwide Cleveland Diagnostics announces Favorable Medicare Local Coverage Determination and Assignment of a CPT-PLA Code for IsoPSA. (Credit: Tatiana from Pixabay) Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today two significant developments regarding the reimbursement of its novel non-invasive, blood-based prostate cancer test, IsoPSA. Medicare Administrative Contractor CGS Administrators, LLC (CGS) has issued a final Local Coverage Decision (LCD) providing favorable coverage for IsoPSA. IsoPSA will now be covered for the millions of men enrolled in Medicare nationwide and provide clearer information to patients and their doctors evaluating whether prostate biopsy is appropriate for them. Medicare covers 60 million men and women beneficiaries nationwide. The effective date for the LCD is November 20, 2022. The AMA has awarded a Proprietary Laboratory Analysis code (CPT-PLA) for IsoPSA, thus providing the mechanism for payment required by payors to uniquely track and reimburse Cleveland Diagnostics for IsoPSA. This CPT-PLA code (0359U) will be effective January 1, 2023. “We are very pleased to receive Medicare coverage and AMA coding for our IsoPSA test,” said Arnon Chait, PhD, Chief Executive Officer of Cleveland Diagnostics. “These coverage and coding determinations are highly significant for physicians and patients, as they will expand access to IsoPSA, a test with multiple clinical indications related to prostate cancer, enabling better informed treatment decisions.” Up to 75% of the prostate biopsies performed in the US are negative for high-grade disease, placing undue burdens on patients, clinicians, and the healthcare system. Unlike the current standard of care in prostate cancer testing, prostate-specific antigen (PSA), which measures merely the concentration of PSA circulating in the blood, IsoPSA interrogates structural variants of PSA, providing clinicians and patients with greater clarity in identifying men who would benefit from prostate biopsy and who would not. In large, prospective multicenter studies of men scheduled for biopsy, IsoPSA demonstrated superior diagnostic accuracy compared to PSA in identifying patients with high-grade cancer. A large real-world clinical utility study has also shown that IsoPSA can reduce the number of unnecessary prostate biopsies by up to 55%. Source: Company Press Release