On November 17, 2020 Proscia, a leading provider of digital and computational pathology solutions, reported that NASA’s Jet Propulsion Laboratory (JPL) and the National Cancer Institute Consortium for Molecular Characterization of Screen-Detected Lesions (MCL), coordinated by Baylor College of Medicine, have deployed Proscia’s Concentriq platform to advance biomedical research on improving cancer treatment (Press release, Proscia, NOV 17, 2020, View Source [SID1234571283]). Through this collaborative program, JPL is digitizing a repository of valuable pathology data to make it readily accessible to researchers from across the seven sites of the MCL. Researchers will use the data to unlock new insights that combat the growing challenge of overdiagnosis, which results in unnecessary treatment of cancers that would have never caused medical problems for the patient.

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While widening access to cancer screening often results in early detection and can increase the likelihood of successful outcomes, it also leads to a rise in the detection of asymptomatic cancers and overtreatment incurring physical and emotional harm to the patient. The MCL, which consists of independent, multi-disciplinary teams, was established to address this issue by undertaking comprehensive molecular and cellular characterizations of tumor tissue, cell, and microenvironment components to more accurately identify aggressive cancers and find minimally invasive methods of treatment. As this research is data intensive, the MCL has partnered with JPL, which will translate its expertise in data analysis around planetary science to this initiative.

The collaborative program requires a scalable, centralized data repository to provide easy access to researchers across the seven sites of the MCL. To create this database, JPL and the MCL have adopted digital pathology, whereby high-resolution images of pathology specimen are captured, and they have deployed Proscia’s Concentriq to serve as the foundational software infrastructure.

Concentriq is a singular image and data management platform that unifies pathology operations across the connected enterprise and accelerates workflows. JPL is using Concentriq to host and manage the data repository, driving consistency for improved visibility and providing intuitive, secure access for the MCL’s team of researchers. Additionally, researchers are leveraging Concentriq to streamline sharing and collaboration so that they can fully capitalize on the collective strengths of the individual sites.

"Collaboration sits at the core of our research," said Dr. Chris Amos, the Principal Investigator of the coordinating center for the MCL and Director for the Institute of Clinical and Translational Medicine at Baylor College of Medicine. "With Concentriq, we are able to centralize the activities of our distributed MCL team while ensuring that everyone can seamlessly work together to accelerate our research and unlock deeper insights."

Proscia’s Concentriq is the digital and computational pathology platform used by leading research organizations and academic and commercial laboratories to transform image-based workflows at scale. The software can be rapidly deployed on existing IT infrastructure and works with leading scanners, laboratory information systems (LIS), and image analysis applications, offering seamless integrations with Philips, Leica, 3DHISTECH, Hamamatsu, and Visiopharm among other solutions.

"We are pleased to welcome JPL and the MCL to the growing roster of leading research organizations using Concentriq," said David West, CEO of Proscia. "Digital pathology is driving biomedical advances by better connecting teams with their data, and we look forward to seeing its impact in addressing the important issue of overdiagnosis."

On November 17, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of two studies in SKIN: The Journal of Cutaneous Medicine, which demonstrated that DecisionDx DiffDx-Melanoma adds significant diagnostic clarity for physicians when characterizing difficult-to-diagnose melanocytic lesions and establishes clinical utility with the potential to improve patient care (Press release, Castle Biosciences, NOV 17, 2020, View Source [SID1234571280]).

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The development and validation study, authored by Dr. Sarah I. Estrada, et al., is titled, "Development and Validation of a Diagnostic 35-Gene Expression Profile Test for Ambiguous or Difficult-To-Diagnose Suspicious Pigmented Skin Lesions." This study describes the development and clinical validation of the DecisionDx DiffDx-Melanoma test, which is designed to refine the diagnoses of suspicious pigmented lesions.

The clinical utility study, authored by Dr. Aaron S. Farberg, et al., is titled, "A 35-Gene Expression Profile Test for Use in Suspicious Pigmented Lesions Impacts Clinical Management Decisions of Dermatopathologists and Dermatologists." This study documents the influence of DecisionDx DiffDx-Melanoma test results on subsequent clinical management decisions, potentially leading to decreased unnecessary procedures while correctly identifying at-risk patients.

Estrada et al. Study Background and Results:

The purpose of this study was to develop and validate DecisionDx DiffDx-Melanoma, including the test’s ability to accurately differentiate between benign and malignant pigmented lesions.
Discovery started with the assessment of 76 genes with quantitative reverse transcription polymerase chain reaction (RT-PCR); artificial intelligence methods were then employed for diagnostic gene selection and algorithm development using 200 benign nevi and 216 melanomas for training. The final algorithm included 32 discriminant and 3 control genes. To reflect the complex biology of melanocytic neoplasia, the DecisionDx DiffDx-Melanoma test was developed to include an intermediate-risk zone.
The results of the study showed that the DecisionDx DiffDx-Melanoma test:
Had a technical success rate of 97%, meaning that a test result was successfully generated;
Achieved accuracy statistics of: Sensitivity = 99.1%, Specificity = 94.3%, Positive Predictive Value = 93.6%, Negative Predictive Value = 99.2%; with an intermediate-risk result in 3.6% of the cases.
Conclusions: DecisionDx DiffDx-Melanoma was developed to refine diagnoses of melanocytic neoplasms by providing clinicians with an objective tool. A test with these accuracy metrics could alleviate uncertainty in difficult-to-diagnose lesions leading to decreased unnecessary procedures while appropriately identifying at-risk patients.
Farberg et al. Study Background and Results:

The purpose of this study was to evaluate DecisionDx DiffDx-Melanoma’s clinical utility.
Dermatopathologists and dermatologists were surveyed regarding diagnostic challenges and patient management strategies in 60 difficult-to-diagnose melanocytic neoplasms. Participants reviewed each lesion twice, once without a DecisionDx DiffDx-Melanoma result and once with. Responses were evaluated for consistent trends in the utilization of the DecisionDx DiffDx-Melanoma test result.
Dermatopathologists utilized the DecisionDx DiffDx-Melanoma result to refine their diagnoses in lesions receiving a benign vs. malignant result (82.3% diagnostic downgrade vs. 94.9% diagnostic upgrade, respectively).
Diagnostic confidence was increased (51%), while additional diagnostic work-up requests were decreased in cases with a benign DecisionDx DiffDx-Melanoma result (72.1%) and increased with a malignant DecisionDx DiffDx-Melanoma result (45.6%).
Conclusions: The diagnosis of challenging melanocytic neoplasms and subsequent clinical management decisions were influenced by DecisionDx DiffDx-Melanoma results in alignment with the test result. The utility of the test may provide the opportunity for clinicians to deliver more informed patient management plans.
About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

On November 17, 2020 The Bristol Myers Squibb Foundation and National Medical Fellowships reported that they have entered into a partnership aimed at improving diversity in clinical trials. Leveraging $100 million of the previously announced commitment from Bristol Myers Squibb and the Bristol Myers Squibb Foundation to diversity and inclusion, the partnership will develop a program to extend the reach of clinical trials into underserved patient populations in urban and rural U.S. communities (Press release, Bristol-Myers Squibb, NOV 17, 2020, View Source [SID1234571278]). This program will train and develop 250 new clinical investigators who are racially and ethnically diverse or who have a demonstrated commitment to increasing diversity in clinical trials, and it will expose 250 promising, underrepresented minority medical students across the country to clinical research career pathways. Additionally, the program will assist program investigators in building capacity and standing up new clinical trials sites in communities with diverse and heavily burdened patient populations.

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The need for diversity in clinical trials

"Clinical research is necessary to generate evidence demonstrating the efficacy and safety of new treatments," said Robert Winn, M.D., Director, Massey Cancer Center, Virginia Commonwealth University, who is serving as chair of the national advisory committee of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program. "While the patient response to medical therapies may differ across racial and ethnic subgroups, clinical trials often fail to represent the demographic diversity of the populations that these products aim to serve. I am proud to serve as an advisor to this program, which will support improvements toward diverse representation in clinical research and promote health equity."

In fact, aggregated data on the racial and ethnic participation in clinical trials published by the FDA show that in general 80% of patients taking part in clinical trials are white. Black Americans represent 13%1 of the US population but only reflect about 7%2 of participants in clinical trials.

John Damonti, president of the Bristol Myers Squibb Foundation added, "Science demonstrates that we must diversify clinical trials in order to improve health outcomes and advance health equity. We are pleased to partner with National Medical Fellowships so that this effort will benefit from their decades of experience and unmatched expertise. Together, we will tap the often overlooked but powerful resource of racially and ethnically diverse physicians or other physicians who have a demonstrated commitment to increasing diversity in clinical trials, working in academic medical centers, community-based practices and Federally Qualified Health Centers. These physicians are established in their communities, and no one is in a better position to build trusting relationships with patients than they are."

"Diversity has a role to play in the entire lifecycle of therapeutic development, from the trial design and community engagement, to therapeutic efficacy and adoption," said Sandra Nichols, M.D., Chairperson, National Medical Fellowships Board of Directors. "National Medical Fellowships has a vision to promote equity of access to quality healthcare for all groups in American society. Advancing diversity in clinical trials is a critically important component of this effort, and our partnership with the Bristol Myers Squibb Foundation is consistent with our mission."

About the program

The goal of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program is to increase diversity of patients enrolled in clinical trials, and ultimately enhance the development of therapeutics for all populations. The program will collaborate with communities to facilitate an approach to clinical and translational research that is community-informed, designed and conducted. It will provide the sponsorship, support and tools that emerging investigators need to conduct clinical trials that will yield the development of new treatments that are effective in all populations.

On November 17, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported a collaboration with Oregon Health & Science University (OHSU) for their development of novel GeoMx Digital Spatial Profiler (DSP) protein assays to spatially profile breast cancer. These assays will be designed to enhance breast cancer tumor analysis and may inform clinical decision-making of patient treatment options. The work will be performed under the GeoMx Translational Leadership Network (GTLN), and the newly formed GeoMx Clinical Consortium, with the goal of developing clinical applications on the GeoMx DSP platform.

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Under the collaboration, pathologists at OHSU intend to design a new GeoMx protein assay with up to 30 targets, including existing breast cancer diagnostic markers and novel biomarker candidates. The GeoMx protein assays will be analytically and clinically validated by OHSU for potential use as laboratory developed tests. The development of a high-content spatial protein test using GeoMx may present new opportunities to enhance pathology insights for improved patient outcomes.

"We believe that the GeoMx DSP is the only spatial platform with the potential to serve the needs of discovery research, translational research, and clinical diagnostics," said Brad Gray, president & CEO of NanoString. "OHSU is a great partner to advance the platform towards the clinical environment and we look forward to collaborating with these thought leaders."

"The development of novel GeoMx DSP protein assays expands the potential applications of spatial biology with the goal of providing better patient care through advanced molecular testing," said Christopher Corless, MD, PhD, Executive Director, Knight Diagnostic Laboratories at the OHSU Knight Cancer Institute. "The GeoMx DSP platform is uniquely suited for this work based on the high-plex and automated capabilities of the system for use with formalin-fixed paraffin-embedded samples."

Dr. Corless of OHSU will present his GeoMx DSP research at the Association for Molecular Pathology (AMP) 2020 Annual Meeting & Expo, which will be held virtually November 16-20.

On November 17, 2020 UroGen Pharma Ltd. (Nasdaq: URGN) reported final topline results from the single-arm, open-label OPTIMA II Phase 2b trial evaluating the efficacy and safety of investigational UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC) (Press release, UroGen Pharma, NOV 17, 2020, View Source [SID1234571273]). As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy. In this subset of patients, duration of response at nine months (12-months from start of therapy) was estimated by Kaplan-Meier analysis to be 72.5%. Median duration of response was not reached. The Company expects to initiate a Phase 3 study evaluating UGN-102 versus current standard of care by the end of the year.

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Treatment with UGN-102 was generally well tolerated and the safety profile was consistent with previously reported results. In the OPTIMA II trial, the majority of the most common adverse events (≥ 10%) were reported as mild to moderate in severity and include dysuria, urinary frequency, hematuria, urinary urgency, urinary tract infection and fatigue. No treatment related serious adverse events were reported.

"The current approach to treating patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer is surgery. In most cases, the cancer comes back and repetitive surgical intervention is required. This puts a tremendous burden on patients and their families and can even be life-threatening," said Andrea Maddox-Smith, Chief Executive Officer, Bladder Cancer Advocacy Network. "Being able to provide patients with an alternative, non-surgical treatment option that is effective, well-tolerated and durable, would greatly benefit those in the patient community."

Patients with LG IR-NMIBC are chronically relapsing and currently, their only treatment option is repeated transurethral resection of bladder tumors (TURBT). Some patients require multiple TURBT surgeries per year, which can lead to increased morbidity and risks associated with repetitive anesthesia. It is estimated that 80,000 people in the U.S. are treated annually for LG IR-NMIBC. This includes newly diagnosed patients and patients who have a recurrence after surgery.

"We are extremely encouraged by the OPTIMA II data and believe UGN-102 has the potential to provide a safe, durable, outpatient treatment alternative for low-grade intermediate risk non-muscle invasive bladder cancer," said Dr. Mark Schoenberg, Chief Medical Officer at UroGen. "We look forward to the expected initiation of our Phase 3 trial this year and further exploring the potential of our innovative technology in advancing new treatments for specialty cancers and urologic diseases."

The Company anticipates submitting the data for presentation at an upcoming medical meeting as well as potential publication in a peer-reviewed journal.

About the Phase 2b OPTIMA II Trial

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) is an open-label, single-arm, multi-center Phase 2b clinical trial of investigational agent UGN-102 (mitomycin) for intravesical solution to evaluate its safety and efficacy in patients with low-grade non-muscle invasive bladder cancer (LG NMIBC) at intermediate risk of recurrence. Intermediate risk is defined as one or two of the following: multiple tumors, solitary tumor >3 cm, or recurrence (≥ 1 occurrence of LG NMIBC within one year of the current diagnosis). Patients were to receive six weekly intravesical instillations of 75 mg UGN-102 in an office setting. The chemoablative effect of UGN-102 was assessed three months after initiation of study treatment with complete response (CR) defined as a negative endoscopic examination, negative cytology, and when indicated, a negative for-cause biopsy. Patients achieving CR were followed quarterly to 12 months after initiation of study treatment to evaluate safety, efficacy, and durability.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer. Utilizing the RTGel Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company reported topline interim results from the Phase 2b OPTIMA II trial in May 2020 and intends to begin a Phase 3 study to further investigate UGN-102 in the treatment of this condition by year end 2020.