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."

On October 31, 2022 Thermo Fisher Scientific, the world leader in serving science, reported that it is showcasing its latest innovative research and diagnostic technologies at the 2022 annual meeting and expo of the Association for Molecular Pathology (AMP) taking place at the Phoenix Convention Center from Nov. 1-5 (Press release, Thermo Fisher Scientific, OCT 31, 2022, View Source [SID1234622643]). The solutions on display are designed to address a broad range of disease states and include assays and instruments that leverage real-time and digital PCR, as well as next generation sequencing (NGS) platforms.

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"Diagnostic tools and access to the most advanced platforms are critical pieces of an effective health care infrastructure because they help clinical laboratories successfully address the challenges they face in assessing health," said Mark Smedley, Senior Vice President and President, Genetic Sciences Group of Thermo Fisher Scientific. "We are committed to continually developing both research and diagnostic innovative solutions to drive toward bettering human health, and we look forward to sharing our latest molecular diagnostic tools that support this endeavor."

Genetic Testing Solutions

As laboratories continue to seek ways to leverage their increased testing capacity following the peak of the COVID-19 pandemic, Thermo Fisher has developed new solutions for other disease research areas, such as respiratory illness, gastrointestinal and urinary tract infections, sexually transmitted diseases, HIV drug resistance, and pharmacogenomics. Some of the research products highlighted at AMP include:

An update to its infectious disease testing portfolio, which now includes the Applied Biosystems TrueMark Respiratory Panels* for viral, bacterial and syndromic testing for research.
The Applied Biosystems QuantStudio Absolute Q Digital PCR System* – a plate-based digital PCR (dPCR) research platform powered by proprietary microfluidic array plate (MAP) technology that enables all necessary steps for dPCR—compartmentalizing, thermal cycling and data acquisition—to be conducted on a single instrument.
Thermo Fisher’s newly expanded Absolute Q Liquid Biopsy dPCR Assays* include products that enable reproducible, specific detection of known somatic mutations for cancer research. Each predesigned assay has been validated using controls to detect down to 0.1% variant allele frequency and can provide results to researchers in less than two hours.
The Applied Biosystems Absolute Q SARS-CoV-2 Wastewater Surveillance Kit*, designed to provide simple, rapid, and consistent absolute quantitation of relevant SARS-CoV-2 targets from wastewater samples by dPCR.
The Applied Biosystems HIV-1 Genotyping Kit with Integrase*, which examines positive samples of human immunodeficiency virus (HIV) to identify genetic variants that resist common antiretroviral therapeutics.
Some of the diagnostic products highlighted at AMP include:

The TaqPath COVID-19, Flu A, Flu B Combo Kit* – an Emergency Use Authorized molecular diagnostic test to detect and differentiate between COVID-19, Influenza A, and Influenza B.
Thermo Fisher’s newest CE-IVD- and IVDR-compliant real-time PCR instruments, the Applied Biosystems QuantStudio 5 DX Real-Time PCR System** and Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System**. Both instruments are designed to provide expandable and streamlined solutions to support in vitro diagnostic (IVD) applications. They provide quick- and easy-to-interpret results and minimize the amount of training needed to get the systems integrated in the lab.
Next Generation Sequencing

To support laboratory needs for fast, comprehensive genomic profiling (CGP), Thermo Fisher is introducing the Genomic Instability Metric (GIM)* as an approach to measure genomic scarring related to homologous recombination deficiency (HRD)*. Details will be presented during one of several company-sponsored workshops at AMP. Thermo Fisher will also feature the Ion Torrent Genexus System*, a true end-to-end NGS workflow designed to provide genomic profiling results in as little as one day.

The company’s booth will also feature the Thermo Scientific AcroMetrix Oncology Hotspot Control***, a highly multiplexed quality control solution that can help assess the performance of NGS assays that detect somatic mutations. It is also intended to provide a means for assessing day-to-day test variation and can help identify increases in random or systematic error.

Thermo Fisher is launching the Molecular Diagnostics Assay Developer Program for OEM partners. This free plan helps companies pursue the development of assays using PCR products, isothermal amplification and NGS workflows. The program also provides access to discounts and commercial rights as companies develop molecular tests.

Workshops and Posters

Thermo Fisher is sponsoring eleven workshops, many of which will highlight the company’s latest platforms and assays, and 19 posters with topics ranging from infectious disease, hematopathology, and solid tumor research, among others. For more information on the workshops, posters and products, we invite you to stop by at Thermo Fisher’s booth (#1308) at AMP or visit: View Source