On October 31, 2022 Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported the publication of two additional major clinical studies relating to its lead product, IsoPSA, for prostate cancer (Press release, Cleveland Diagnostics, OCT 31, 2022, View Source [SID1234622648]).

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The first publication—appearing in the peer-reviewed journal, Urologic Oncology: Seminars and Original Investigations (the official journal of the Society of Urologic Oncology)—describes a large, prospective, multicenter clinical validation study led by Dr. Eric Klein, Emeritus Professor and Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic. In this study, investigators validated the diagnostic performance and predictive value of IsoPSA for both high-grade and any prostate cancer in men age ≥ 50 with total PSA ≥ 4 ng/mL, confirming that IsoPSA outperforms standard of care tests (total and % free PSA) in discriminating the risk of prostate cancer on subsequent biopsy and demonstrating the test’s potential to both reduce unnecessary biopsies and to improve the risk-benefit ratio for early detection of prostate cancer.

In this study, a total of 888 patients being evaluated for prostate cancer were enrolled at eight leading academic and community healthcare centers in the United States to validate the clinical performance of IsoPSA. This study demonstrated significant improvements in diagnostic accuracy vs. standard of care tests and provided support for a novel clinical paradigm that not only incorporates the use of IsoPSA following elevated PSA results, but also prior to MRI during prostate biopsy decision making.

This study highlights key attributes that differentiate IsoPSA in the early detection of prostate cancer including the ability of IsoPSA to distinguish the risk of both high‐grade and any‐grade of prostate cancer, diagnostic accuracy across a broad range of triggering total PSA levels (4‐100 ng/mL) seen in clinical practice, and the consistent and substantial diagnostic performance of the test in both biopsy naïve and prior negative biopsy patient groups.

"Our clinical validation study reaffirms that IsoPSA is a valuable tool that can provide urologists with critical information needed to determine which patients need to go to biopsy and which do not," said Dr. Klein. "I believe that IsoPSA will lead to fewer unneeded biopsies and reduce overdiagnosis of indolent prostate cancer and thereby reduce overtreatment."

In the second study, published in Urology (the "Gold Journal"), Benidir, et al. describe a retrospective analysis of real-world data representing outcomes associated with IsoPSA use. In the study, investigators evaluated patients who went on to radical prostatectomy following elevated IsoPSA values which triggered biopsy.

"In real world applications, our study demonstrated that IsoPSA does not select for any particular adverse pathologic feature upon radical prostatectomy. IsoPSA is a reliable tool for the identification of clinically significant prostate cancer," commented lead author Dr. Chris Weight of Cleveland Clinic.

As a non-biased, agnostic predictor of meaningful disease, IsoPSA was demonstrated to be valuable even in cases where biopsy histology and radiology may not accurately reflect the current biology of disease. Study investigators observed that many so-called "false positive" IsoPSA results may actually be true positives for high-grade cancer given that biopsies (the standard to which IsoPSA is compared in earlier prospective clinical studies) have been known to miss 20-30 percent of cancers. In this study, 99 percent of patients with IsoPSA indices greater than 6.0 (the IsoPSA threshold that triggers biopsy) had clinically significant prostate cancer on subsequent radical prostatectomy, the ultimate determinant of disease status.

"Cleveland Diagnostics is fully committed to supporting and publishing results from high quality studies. The clinical validation study adds to the already extensive stable of clinical evidence supporting IsoPSA, which indicates superior clinical performance and biopsy reductions," said Arnon Chait, PhD, Chief Executive Officer at Cleveland Diagnostics. "The independent real-world outcomes study is another example of the growing number of key publications authored by clinicians using the test in their practices, and supports the use of IsoPSA earlier in the diagnostic paradigm. Due to data such as those highlighted in these two important new publications, we continue to see rapid clinical adoption of the test, and expect that IsoPSA will become an integral part of every urologist’s workflow."

Together with the results of previously-published clinical validation, clinical utility, and cost effectiveness data, these new studies lend further support for the notion that IsoPSA has the ability to not only dramatically reduce the number of unnecessary procedures but also identify patients with clinically significant cancer that may even be missed by MRI and biopsy. This, in turn, could generate significant savings to the healthcare system and improve patient outcomes.

On October 31, 2022 Siemens Healthineers and UHealth – University of Miami Health System reported a Value Partnership1 agreement (Press release, Siemens Healthcare, OCT 31, 2022, View Source [SID1234622647]). This strategic relationship will further technological advancement and standardization of equipment at the health system, while allowing the University to create educational and training programs for clinicians and technologists. This unique agreement is the first of its kind in Florida.

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Through this planned ten-year agreement, UHealth will acquire the latest medical technology equipment from both Siemens Healthineers and Varian, a Siemens Healthineers company that will help expand diagnostic and therapeutic treatments. Other aspects of the agreement include educational and service offerings, digital health technology, and consulting services.

Also, through the collaboration, new clinical and operational strategies will be developed and deployed to evolve care, enhance diagnosis, and improve the overall health of Floridians.

"Building new clinical structures over the next few years, our goal is to incorporate the latest technological advances to serve our patients," said Alexander McKinney, M.D., chair of the Department of Radiology at the University of Miami Health System. "We look forward to working with the team at Siemens Healthineers."

In conjunction with adding world-class medical technology equipment at UHealth’s various locations throughout Florida, technology from Siemens Healthineers will be used in training the next generation of physician.

"Our equipment and solutions will be a great addition to the University of Miami Health System’s already rapidly expanding footprint, allowing it to expand its educational and training offerings across the region," said David Pacitti, president and head of the Americas, Siemens Healthineers. "This Value Partnership is a proof point of the unbroken, strong demand for Siemens Healthineers’ products, services and solutions in the North American market."

1 Value Partnership is a branded enterprise service offering from Siemens Healthineers. The term "Value Partnership" does not imply, create, and/or establish a legal partnership or joint venture between Siemens Healthineers and the University of Miami Health System.

On October 31, 2022 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher"), the world leader in serving science, reported that it has entered into a definitive agreement to acquire The Binding Site Group ("The Binding Site"), a global leader in specialty diagnostics, from a shareholder group led by European private equity firm Nordic Capital, in an all-cash transaction valued at £2.25 billion, or $2.6 billion at current exchange rates (Press release, Thermo Fisher Scientific, OCT 31, 2022, View Source [SID1234622646]).

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Serving clinicians and laboratory professionals worldwide, The Binding Site provides specialty diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders. The Binding Site’s Freelite offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications.

Headquartered in Birmingham, United Kingdom, The Binding Site has more than 1,100 employees globally and is an active and influential contributor to the broader scientific community. As an established leader in a fast-growing segment in which patient care has shifted towards early diagnosis and monitoring via regular testing, The Binding Site has an attractive financial profile. Its business has been growing approximately 10% annually and is on track to deliver more than $220 million of revenue in 2022. The strong clinical value of The Binding Site offering enables doctors across the globe to support millions of patients every year.

"This transaction perfectly aligns with our Mission and is an exciting addition to our existing specialty diagnostic offerings. With extensive expertise and a large and dedicated installed base in cancer diagnostics, The Binding Site will further enhance our specialty diagnostics portfolio," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher. "The Binding Site is extremely well-respected by researchers and clinicians alike for its pioneering diagnosis and monitoring solutions for multiple myeloma. We also know early diagnosis and well-informed treatment decisions for multiple myeloma can make a significant difference in patient outcomes. We are excited by the opportunity to enable further innovation in this area for the benefit of patients and look forward to welcoming The Binding Site team to Thermo Fisher."

Stefan Wolf, chief executive officer of The Binding Site, said, "This announcement marks the beginning of a new and exciting chapter for The Binding Site and is a testament to our team’s singular commitment to improving patient lives through the development and delivery of innovative solutions. The Binding Site has long been at the forefront of medical diagnostics and by joining the world leader in serving science, we will be even better positioned to accelerate scientific discovery and expand our product offering for the benefit of our colleagues, customers and, most importantly, the patients we serve."

The transaction, which is expected to be completed in the first half of 2023, is subject to customary closing conditions, including regulatory approvals. Upon completion, The Binding Site will become part of Thermo Fisher’s Specialty Diagnostics segment and is expected to be accretive to adjusted earnings per share by $0.07 for the first full year of ownership.1

On October 31, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported the publication of real-world clinical utility data in Cancer Investigation showing that clinicians are ordering DecisionDx-SCC for the intended high-risk cutaneous squamous cell carcinoma (SCC) patient population and that use of the test’s results can lead to risk-aligned changes in patient management strategies (Press release, Castle Biosciences, OCT 31, 2022, View Source [SID1234622645]).

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"The study highlighted the challenges of accurate risk assessments in the management of SCC when using clinicopathologic staging systems alone, and reinforced the need for a risk-stratification tool like DecisionDx-SCC that is designed to better identify patients with a higher likelihood of experiencing poor outcomes," said Perry B. Hooper, M.D., Department of Dermatology, Indiana University School of Medicine, Indianapolis. "The personalized information provided by the test’s results can positively impact decision-making for SCC patients by helping better align treatment plans to a patient’s biologic metastatic risk and reducing the likelihood of over- or undertreatment."

The paper, titled "Real-World Evidence Shows Clinicians Appropriately Use the Prognostic 40-GEP Test for High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) Patients," evaluated metrics from one year of clinical DecisionDx-SCC orders and the test’s impact on real-world risk assessments and treatment decisions. The paper may be viewed from Castle’s website.

Metrics from real-world DecisionDx-SCC orders during the first year of testing show that physicians are ordering DecisionDx-SCC for patients with one or more high-risk clinicopathologic factors:

Of the 2,503 samples tested between Aug. 31, 2020-Aug. 31, 2021, 98.1% were successfully tested and received the following results: 68.8% received a low-risk (Class 1) result, 28.3% received a moderate-risk (Class 2A) result and 2.9% received a high-risk (Class 2B) result.
75% of samples had two or more high-risk clinicopathologic factors, and 98.8% of cases submitted for testing were classified as high risk or very high risk by the National Comprehensive Cancer Network (NCCN) guidelines, which closely aligns with the intended use population of the DecisionDx-SCC test.
Despite elevated clinicopathologic metastatic risk in these real-world patients, 68.8% received a low-risk (Class 1) DecisionDx-SCC test result, reinforcing the clinical need for risk assessments that incorporate a patient’s tumor biology to better align patient management plans with their biologic metastatic risk.
Real-world data involving healthcare providers who have clinical experience with DecisionDx-SCC indicates that patient management decisions can be impacted when the test’s results are considered:

Clinicians who ordered DecisionDx-SCC ten or more times during the first year of clinical orders were invited to participate in an anonymous survey study, where they were provided with six real-world high-risk SCC cases and asked what their treatment approach would be, both pre- and post-DecisionDx-SCC testing.
The clinicians who responded (n=34) were generally well-aligned regarding the different baseline risk levels (pre-test) inherent in each of these real-world patient cases. After receiving DecisionDx-SCC test results (post-test), the clinicians aligned their overall post-test management strategy for each case and adjusted the intensity of their treatment plans significantly in a risk-aligned manner depending on the metastatic risk represented by each case’s DecisionDx-SCC result. These changes were seen in specific treatment plans regarding nodal assessment via imaging, surveillance imaging, follow-up frequency, adjuvant radiation therapy and sentinel lymph node biopsy (SLNB).
Overall, the study data support the positive impact that DecisionDx-SCC’s personalized, risk-stratification results can have on patient management plans, including:
Helping avoid the overtreatment of patients: As an example, in Case 1 (which had the highest level of baseline overall management strategy), between 44 and 58% of clinicians who responded to the survey chose to de-escalate their overall management strategy and reduce their likelihood of performing adjuvant radiation therapy, SLNB, imaging (nodal assessment and surveillance) after receiving a low-risk (Class 1) test result, demonstrating the potential of the test to help avoid the overtreatment of patients.
Guiding risk-appropriate disease management decisions, alongside traditional risk factor assessments: Across all six cases, a comprehensive analysis of the clinical impact that a DecisionDx-SCC class result had on clinicians making risk-aligned changes in treatment intensity demonstrated a mean average of 47.9% for their overall management strategy approach.
About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

On October 31, 2022 Turnstone Biologics Corp, a clinical-stage biotechnology company developing next-generation immunotherapies to treat and cure solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) for Turnstone’s lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01 (Press release, Turnstone Biologics, OCT 31, 2022, View Source [SID1234622644]). Turnstone is expected to commence a multi-site Phase 1 clinical trial later this year that will evaluate its safety and anti-tumor activity. This trial represents the second Phase 1 clinical study of TIDAL-01, which separately is being evaluated in collaboration with Moffitt Cancer Center.

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"Clearance of our IND is a critical milestone for Turnstone in the advancement of our novel TIL therapy pipeline," said Sammy Farah, Ph.D., M.B.A., President and Chief Executive Officer, Turnstone Biologics. "TIDAL-01 is a potentially transformative approach to improving the potency of TILs and bringing the clinical benefit of Selected TILs to patients with solid tumor cancers where the unmet medical need is high. We are eager to commence the clinical study for TIDAL-01 and to progress this candidate through the clinic."

Selected TILs represent the foundational therapeutic modality driving Turnstone’s cancer immunotherapy pipeline and leverage decades of work anchored in academic research that has demonstrated the promise of this approach. By identifying, selecting, and expanding the most potent subsets of patient specific tumor-reactive T-cells, Turnstone aims to improve and broaden the clinical efficacy of TILs, and to overcome the limitations of current TIL-based therapies to achieve positive outcomes in harder to treat, lower mutational burden cancers. The STARLING trial, Turnstone’s multi-site Phase 1 clinical trial of TIDAL-01, will enroll patients with advanced solid tumors including breast cancer and colorectal cancer. Additionally, TIDAL-01 is being evaluated in a Moffitt Cancer Center-sponsored Phase 1 clinical study in additional solid tumors, including cutaneous and non-cutaneous melanoma.

"To achieve success against solid tumors, we are applying a differentiated approach with TILs to overcome what we believe to be the greatest barrier to more effective cell therapies: the low amount of T-cells that recognize and attack the tumor," said Stewart Abbot, Ph.D., Chief Scientific Officer, Turnstone Biologics. "In identifying, selecting and expanding these tumor-reactive T-cells, we aim to drive more potent solid tumor killing and improved clinical outcomes in multiple different cancer indications."