On October 24, 2022 CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, reported that acceptance of an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, held virtually and in person in Boston, MA from November 8-12, 2022 (Press release, CG Oncology, OCT 24, 2022, View Source [SID1234622318]).

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CG Oncology will present safety and efficacy data from CORE1, an ongoing Phase 2 clinical trial of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which is fully enrolled with 35 patients treated with therapy, is to evaluate the safety and efficacy of CG0070 plus pembrolizumab for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Details of the oral presentation are as follows:

Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Abstract Number: 666
Session: Concurrent Session 105: Rapid Oral Abstracts – Clinical
Presenter: Dr. Roger Li, M.D., lead study investigator and Urologic Oncologist at Moffitt Cancer Center
Presentation Date & Time: Thursday, November 10, 2022, 11:55am-12:55pm Eastern Standard Time
Location: Boston Convention & Exhibition Center, Room 258ABC, or online at View Source

About CG0070

Our lead candidate, CG0070, is an intravesically delivered selective oncolytic immunotherapy agent that is currently in a Phase 3 trial for the treatment of BCG-unresponsive NMIBC. It is also in Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO (nivolumab).

On October 24, 2022 Daiichi Sankyo (TSE: 4568) reported that it received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive (Press release, Daiichi Sankyo, OCT 24, 2022, View Source [SID1234622317]). The application has been granted Priority Review.

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The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date (PDUFA), the FDA action date for their regulatory decision, is April 24, 2023. The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.

AML is one of the most common forms of leukemia in adults.1 An estimated 20,050 new cases of AML will be diagnosed in the U.S. in 2022, and the five-year overall survival rate is reported at 30.5%.1,2 Of all newly diagnosed cases of AML, approximately 25% have the FLT3-ITD mutation, which is associated with particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.3

"There is a need for new targeted therapy options for patients with acute myeloid leukemia and the results of the QuANTUM-First trial showed that quizartinib in combination with standard chemotherapy has potential to change the current standard of care for newly diagnosed patients with the historically difficult-to-treat FLT3-ITD subtype," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "The FDA’s prioritization of this application reflects the importance of the data, and we will continue to work with the FDA and other global regulatory authorities to support the review of quizartinib for the treatment of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia."

The NDA is based on data from the QuANTUM-First phase 3 trial presented at the Presidential Symposium of the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress. In QuANTUM-First, quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and continued as monotherapy following consolidation, demonstrated a statistically significant and clinically meaningful improvement in overall survival in adult patients with newly diagnosed FLT3-ITD positive AML compared to chemotherapy alone. The safety of quizartinib combined with intensive chemotherapy and as continuation monotherapy in QuANTUM-First was generally manageable with no new safety signals observed. The incidence of grade ≥3 QT prolongation events was low, with uncommon ventricular arrythmia events. Overall, the risk of QT prolongation was manageable with ECG monitoring, quizartinib dose modification and correction/elimination of additional risk factors.

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled global phase 3 study evaluating quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens. Eligible patients, including those who underwent hematopoietic stem cell transplant (HSCT), continued with quizartinib or placebo for up to 36 cycles.

The primary study endpoint was overall survival. Secondary endpoints include event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, also were evaluated. QuANTUM-First enrolled 539 patients at 193 study sites across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About Acute Myeloid Leukemia

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.4 In 2017, AML accounted for 23.1% of total leukemia cases worldwide, and it is one of the most common types of leukemia in adults.5,1 In the U.S., an estimated 20,050 new cases of AML will be diagnosed in 2022 with the five-year survival rate reported at 30.5%.1,6

The conventional treatment for newly diagnosed AML is intensive induction and consolidation chemotherapy with HSCT for eligible patients.7 The introduction of new targeted therapies in recent years has added to the standard of care and improved outcomes for some patients with molecularly defined AML subtypes.8 However, there remains a need to improve survival for the majority of patients with AML.7

About FLT3-ITD

FLT3 (FMS-like tyrosine kinase 3) is a tyrosine kinase receptor protein normally expressed by hematopoietic stem cells that plays an important role in cell development, promoting cell survival, growth and differentiation through various signaling pathways.3 Mutations of the FLT3 gene, which occur in approximately 30% of AML patients, can drive oncogenic signaling.3 FLT3-ITD (internal tandem duplication) is the most common type of FLT3 mutation in AML, occurring in about 25% of all newly diagnosed patients, and is associated with increased risk of relapse and shorter overall survival.3

About Quizartinib

Quizartinib is an oral, highly potent and selective type II FLT3 inhibitor currently in clinical development for treatment of FLT3-ITD positive AML.4 In addition to QuANTUM-First, the quizartinib development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD positive AML in Europe and North America. Several phase 1/2 combination studies with quizartinib also are underway at The University of Texas MD Anderson Cancer Center as part of a strategic research collaboration focused on accelerating development of Daiichi Sankyo pipeline therapies for AML.

In addition to U.S. FDA Priority Review, quizartinib has received Fast Track Designation from the FDA for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive, in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy. Orphan Drug Designation has been granted to quizartinib for the treatment of AML in Europe, Japan and the U.S.

Regulatory applications are currently under review in Europe and Japan for quizartinib in the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive, in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, based on the results of the QuANTUM-First trial.

Quizartinib is currently approved for use in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan.

On October 24, 2022 Naveris, Inc., a leader in molecular diagnostics for viral cancers, reported that the company and the principle investigator at Mayo Clinic will present its award-winning abstract at the American Society for Radiation Oncology (ASTRO) Annual Meeting held October 23-26, 2022 (Press release, Naveris, OCT 24, 2022, View Source [SID1234622315]). This presentation describes significant new data supporting the clinical value of NavDx, the first and only clinically validated circulating tumor-tissue-modified HPV (TTMV) DNA blood test, as a non-invasive blood test to assess the risk of disease recurrence after treatment in patients with human papilloma virus (HPV)-driven head and neck cancer. David Routman, M.D. radiation oncologist, Mayo Clinic, and first author of the study, was honored with the ASTRO Basic/Translational Science Award for this work.

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This study investigated use of the NavDx test to detect molecular residual disease (MRD) following treatment in patients with head and neck cancer, as part of the phase III MC1675 clinical trial. NavDx-detected MRD was a significant risk factor for cancer recurrence. The presence of MRD, both in the post-operative setting and at 3 months post-treatment, was significantly associated with shorter progression-free survival. Of patients with a positive NavDx test at 3 months post-treatment, 75% developed recurrence by 18 months, whereas only 2.8% of patients with a negative NavDx test at 3 months post-treatment developed recurrence within the same time period. Results from the MC1675 trial were initially presented at the ASTRO 2021 annual meeting and follow-up is ongoing.

Naveris and Mayo Clinic are continuing their collaboration with the recently announced DART 2.0 prospective clinical trial (NCT05541016), which will investigate the value of TTMV-HPV DNA as a biomarker and the ability of NavDx to directly inform treatment decisions for patients with HPV-driven head and neck cancer.

"Naveris’ collaboration with the Mayo Clinic illustrates how advances in molecular diagnostics are creating paradigm shifts in the fight against cancer," said Piyush Gupta PhD, Founder and CEO of Naveris. "We are delighted to be partnering with Drs. Ma, Routman, Van Abel and their colleagues on this groundbreaking clinical research, which aims to improve patient outcomes while reducing the side-effects and morbidity of medical treatment."

"This report validates NavDx as a valuable tool after surgery for assessing the risk of post-operative cancer recurrence in these patients, which enables early diagnostic and therapeutic interventions," said Barry M. Berger MD, Chief Medical Officer of Naveris.

More information on Naveris and NavDx can be found at booth #2348, or look for highlights from #ASTRO22 Twitter and LinkedIn. The data presented will be made available on the Naveris website at www.naveris.com/clinical-publications/.

On October 24, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported results from its Phase 3 SPOTLIGHT trial that evaluated the impact of various clinical factors, including baseline Prostate Specific Antigen (PSA) levels, PSA doubling time and Gleason score, on detection rates (DRs) for 18F-rhPSMA-7.3 in recurrent prostate cancer (Press release, Blue Earth Diagnostics, OCT 24, 2022, View Source [SID1234622314]). 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in an oral presentation at the American Society for Radiation Oncology (ASTRO) 2022 Annual Meeting in San Antonio, Texas.

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"The ability to determine the extent and location of recurrent prostate cancer to inform appropriate clinical management for these men is key for physicians and their patients, because up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years," said Benjamin Lowentritt, MD, Chesapeake Urology Research Associates, Towson, Md., on behalf of the SPOTLIGHT Study Group. "A rising PSA after radical prostatectomy usually precedes a clinically detectable recurrence by years, but cannot differentiate between local, regional, or systemic disease. The utility of conventional imaging for the localization of recurrence is limited, particularly in patients with low PSA levels. Relapse after curative-intent primary treatment remains a considerable clinical burden, and precise imaging techniques are required to identify areas of involvement to facilitate the delivery of optimized patient management. These findings from the SPOTLIGHT study showed high DRs by majority read for 18F-rhPSMA-7.3 PET over a wide range of baseline PSA levels."

"These results from the Phase 3 SPOTLIGHT trial in biochemically recurrent prostate cancer are included in our New Drug Application for 18F-rhPSMA-7.3 PET imaging currently under review by the U.S. Food and Drug Administration, and we are pleased that they are being presented to the radiation oncology community at ASTRO 2022," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "In line with our mission to help patients with cancer across the care continuum, Blue Earth Diagnostics continues to develop our comprehensive prostate cancer portfolio, which includes 18F-fluciclovine and investigational rhPSMA compounds for potential use in diagnostic PET imaging and targeted radiopharmaceutical therapy. 18F-rhPSMA-7.3 represents a new class of PSMA-targeted PET radiopharmaceuticals, with early studies 18F‐rhPSMA‐7.3 showing a high binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity."

The findings presented at ASTRO included analyses of clinical factors impacting DRs for 18F-rhPSMA-7.3 evaluated by three blinded central readers: DRs, including region-level analyses, stratified by baseline PSA levels, PSA doubling time, Gleason score and prior treatment (radical prostatectomy with or without radiotherapy, or radiotherapy only). For example, results showed that among the 389 patients in the Evaluable PET Scan Population, the patient-level DR of 18F-rhPSMA-7.3 PET by majority read was 83% (322/389). When stratified by PSA level, the DRs were: PSA <0.5 ng/mL: 64% (77/121); PSA ≥0.5 and <1 ng/mL: 76% (51/67); PSA ≥1 and <2 ng/mL: 93% (42/45); PSA ≥2 and <5 ng/mL: 98% (86/88); PSA ≥5 and <10 ng/mL: 94% (34/36); and PSA ≥10 ng/mL: 100% (32/32). As noted previously, no serious adverse reactions were attributed to 18F-rhPSMA-7.3 PET in the SPOTLIGHT study. Overall, 16 (4.1%) patients had at least one treatment-emergent adverse event that was considered possibly related/related to 18F-rhPSMA-7.3. The most frequently reported events were: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection site reaction: 0.5% (n=2), and headache: 0.5% (n=2).

The SPOTLIGHT trial (NCT04186845) is a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO (Free ASCO Whitepaper) GU in February 2022,1 with additional results announced at AUA in April 20222 and at SNMMI in June 2022.3

The findings were discussed in an oral presentation at ASTRO 2022 on October 24, 2022, "Impact of clinical factors on 18F-rhPSMA-7.3 detection rates in men with recurrent prostate cancer: Findings from the phase 3 SPOTLIGHT study," by Benjamin Lowentritt, MD, Chesapeake Urology Research Associates, Towson, Md., on behalf of the SPOTLIGHT Study Group. Full session details and the abstract are available in the ASTRO online program HERE.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

On October 24, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from UTILISE (Clinical Utility and Health Outcomes Study), a prospective, multi-center, clinical utility study of DecisionDx-SCC, designed to capture the real-world impact of DecisionDx-SCC test results on the management of patients with cutaneous squamous cell carcinoma (cSCC) and one or more risk factors (Press release, Castle Biosciences, OCT 24, 2022, View Source [SID1234622313]). This first analysis showed that DecisionDx-SCC test results positively impacted patient management in over 80% of the patients enrolled in the study, consistent with previous clinical utility studies demonstrating that the test’s results can impact risk-appropriate changes in patient management plans, within established guidelines.

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"A true litmus test of any prognostic test is its ability to provide clinically actionable information that can drive positive change in the overall management of patients and more informed decisions than may be possible without the test’s results," said Matthew S. Goldberg, M.D., board-certified dermatologist and dermatopathologist and medical director at Castle Biosciences. "The initial data from our UTILISE study highlights the potential of DecisionDx-SCC test results to prompt risk-aligned changes in treatment plans for patients with high-risk cSCC, with clinical actionability rates comparable to the impact of molecular tests currently covered by Medicare for other disease states, such as breast, prostate and lung cancer."

This data from the UTILISE study was presented during the 2022 Fall Clinical Dermatology Conference through a poster titled, "A prospective clinical utility study demonstrates that physicians use the 40-gene expression profile (40-GEP) to guide clinical management decisions for Medicare-eligible patients with cutaneous squamous cell carcinoma (cSCC)." The poster can be viewed here.

In the study, clinician recommendations for patient management are recorded before and after DecisionDx-SCC testing using standard pre-test/post-test methodology, and any additional changes in management plans and patient outcomes are recorded every six months for three years. In this analysis of Medicare-eligible patients with high-risk cSCC (n=59), clinicians indicated that the DecisionDx-SCC test result was the most influential factor impacting their management plans for 42% of the patients. Additionally, DecisionDx-SCC test results positively impacted patient management in over 80% of patients in the cohort, with clinicians reporting increased confidence in the recommended treatment plan (59%) and risk-aligned management changes based on the tests’ results (24%). While additional analyses from UTILISE are forthcoming, the initial data from this real-world study support findings in previous clinical utility studies that DecisionDx-SCC provides valuable risk-stratification information that can guide patient management decisions and risk-appropriate treatment plan changes within established guidelines.

The following additional posters highlighting the performance of Castle’s suite of tests for skin cancer were also shared during the 2022 Fall Clinical Dermatology Conference:

DecisionDx-Melanoma

Poster titled, "Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: A Surveillance, Epidemiology, and End Results (SEER) Program collaboration," is available to view here.
Diagnostic GEP (MyPath Melanoma and DiffDx-Melanoma)

Poster titled, "A clinical impact study of dermatologists’ use of the 23- or 35-gene expression profile tests to guide surgical excision and enhance management plan confidence," is available to view here.
DecisionDx-SCC

Poster titled, "How Mohs surgeons utilize prognostic testing for high-risk cutaneous squamous cell carcinoma (SCC): a clinical impact study," is available to view here.
Poster titled, "Performance and clinical decision-making using the prognostic 40-gene expression profile (40-GEP) test in 1,018 patients with high-risk cutaneous squamous cell carcinoma (SCC)," is available to view here.
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.

About MyPath Melanoma and DiffDx-Melanoma

MyPath Melanoma and DiffDx-Melanoma are Castle’s two gene expression profile tests designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two 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. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a risk stratification gene expression profile test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma.