Prostate Cancer, Hereditary, 7

EDMONTON, Alberta & CALGARY, Alberta--( BUSINESS WIRE )-- Nanostics Inc. , a precision health company developing diagnostic tests with its ClarityDX® platform technology, and OncoHelix , a leader in precision diagnostics, today announced their partnership to provide ClarityDX Prostate® to healthcare providers and men in the Middle East. ClarityDX Prostate uses biological data, clinical information, and AI-powered learning models to generate a risk score for aggressive prostate cancer, marking a significant advancement in prostate cancer screening. It provides critical support to men and their healthcare providers in making more informed decisions about whether to proceed with a biopsy following a high prostate-specific antigen (PSA) test result or abnormal digital rectal examination (DRE) result. OncoHelix provides advanced molecular diagnostics and immune profile testing to the Middle East and North Africa (MENA) region through OncoHelix-coLAB, a state-of-the-art laboratory within Burjeel Medical City, Abu Dhabi. This facility is a joint venture between OncoHelix and Burjeel Holdings, one of the largest healthcare providers in the Middle East. The OncoHelix-coLAB facility will now also provide Nanostics’ ClarityDX Prostate diagnostic tool to men at risk of having aggressive prostate cancer. The addition of this test will further enhance patient diagnostics and treatment outcomes in the region. “Partnering with OncoHelix, another Alberta-based company, to bring ClarityDX Prostate to men in the Middle East really shows how relevant Alberta-developed technology has become to the world,” said Dr. John Lewis, CEO of Nanostics and Bird Dogs Chair of Translational Oncology at the University of Alberta. “ClarityDX Prostate is a powerful diagnostic tool that can help identify men with aggressive prostate cancer early. We want all men to benefit from early detection leading to better outcomes.” “We are thrilled to partner with Nanostics to bring the ClarityDX Prostate test to the Middle East. This advanced diagnostic tool will empower healthcare providers with better, data-driven insights, enabling earlier detection and more targeted treatment for men at risk of aggressive prostate cancer in the region,” said Faisal Khan, CEO of OncoHelix. ClarityDX Prostate is available in the USA as CDX Prostate from Protean BioDiagnostics. Go to https://www.proteanbiodx.com/cdxprostate#pcdx-order for more information and to order the test. In Canada, the test is available in most provinces through Nanostics’ CPSA-accredited lab in Alberta. Go to www.nanosticsdx.com for more information or to order the test. In Quebec, testing services are available from CDL Laboratories, visit cdllaboratories.com for information. About OncoHelix OncoHelix is a Calgary-based organization recognized in Canada and internationally as a leader in advanced molecular and immune diagnostics. The company has developed an exceptional precision oncology testing portfolio alongside a growing pipeline of wellness and reproductive health tests. OncoHelix is partnered with the Hematology Translational Lab (HTL) at the University of Calgary, forming one of the largest clinically-accredited lab diagnostics providers in Western Canada. OncoHelix also operates the state-of-the-art OncoHelix-coLAB in partnership with Burjeel Holdings in Abu Dhabi, bringing cutting edge diagnostic solutions closer to patients in the UAE and broader MENA region. Read more at: www.oncohelix.org . Follow OncoHelix on LinkedIn . About Nanostics Inc. Nanostics Inc is a private Canadian company that develops and commercializes novel and noninvasive diagnostic tests. Its core technology, ClarityDX®, uses advanced machine learning algorithms to create a disease risk score that predicts the presence of diseases. ClarityDX is applicable to a wide range of cancers and other diseases. Nanostics’ lead product, ClarityDX Prostate®, also called CDX Prostate in the United States, is a test that improves the accuracy of detecting clinically significant prostate cancer. Read more at: www.nanosticsdx.com . Follow Nanostics on LinkedIn , YouTube , Facebook , and Instagram .

BOSTON--( BUSINESS WIRE )-- Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne ® CDx and FoundationOne ® Liquid CDx to be used as companion diagnostics for AstraZeneca’s and Merck’s (known as MSD outside of the United States and Canada) Lynparza ® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). This decision from the FDA follows the approval of FoundationOne CDx for Lynparza to identify mCRPC patients with homologous recombination repair (HRR) gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1 , BRCA2 and/or ATM alterations in mCRPC. Prostate cancer is one of the most common cancers in men. 1 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease, 2 occurring in approximately 11% of diagnoses. 3 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis. 4 “This approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “Our high-quality tissue and liquid biopsy companion diagnostic tests will allow more patients to access genomic testing, regardless of specimen type, and will simplify complex decisions by generating the best information to enable better decision-making. There is a critical unmet need for first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this combination therapy is an important advancement.” Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. From a simple blood sample, FoundationOneLiquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. With today’s approval, Foundation Medicine is the only company that has seven FDA-approved companion diagnostic indications for prostate cancer. 5 Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing. 6 “This is an important milestone for men with aggressive prostate cancer,” said Courtney Bugler, President and CEO of ZERO Prostate Cancer. “Biomarker testing is an important tool for patients and families to help facilitate personalized treatment decision making, and we applaud Foundation Medicine for these additional companion diagnostic indications.” Lynparza is jointly developed and commercialized by AstraZeneca and Merck. Foundation Medicine and FoundationOne ® are registered trademarks of Foundation Medicine, Inc. About Foundation Medicine: Your Essential Partner in Cancer Care Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X . About FoundationOne ® CDx FoundationOne ® CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com . About FoundationOne ® Liquid CDx FoundationOne ® Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com . ____________________________ 1 Cancer.net. Prostate Cancer: Statistics. Updated March 2023. Accessed August 19, 2024. https://www.cancer.net/cancer-types/prostate-cancer/statistics 2 Castro E, Eeles R. The role of BRCA1 and BRCA2 in prostate cancer. Asian J Androl. 2012;14(3):409-414. https://doi.org/10.1038/aja.2011.150 3 Valsecchi AA, Dionisio R, Panepinto O, et al. Frequency of Germline and Somatic BRCA1 and BRCA2 Mutations in Prostate Cancer: An Updated Systematic Review and Meta-Analysis. Cancers. 2023; 15(9):2435. https://doi.org/10.3390/cancers15092435 4 Messina C, Cattrini C, Soldato D, et al. BRCA Mutations in Prostate Cancer: Prognostic and Predictive Implications. J Oncol. 2020;2020:4986365. Published 2020 Sep 7. https://doi.org/10.1155/2020/4986365 5 Data on File, Foundation Medicine, Inc. 2024 6 Data on File, Foundation Medicine, Inc., data as of March 2024

FRIDAY, July 19, 2024 -- Expression of several stress-related genes in prostate tumors is elevated among men residing in disadvantaged neighborhoods, according to a study published online July 12 in JAMA Network Open . Joseph Boyle, Ph.D., from Virginia Commonwealth University in Richmond, and colleagues examined whether several neighborhood disadvantage metrics are associated with prostate tumor RNA expression of stress-related genes in a cross-sectional study. A total of 105 stress-related genes were assessed with each neighborhood metric for 168 African American and 50 White men with prostate cancer who received radical prostatectomy. The researchers found that compared with White participants, African American participants experienced greater neighborhood disadvantage (median Area Deprivation Index [ADI], 115 versus 92; median Racial Isolation Index, 0.68 versus 0.11). There was a positive association for ADI with expression of 11 genes; after multiple-comparison adjustment, HTR6 (serotonin pathway) remained significant. Associations were seen for several genes, including HTR6 , with multiple metrics. Higher expression of five proinflammatory genes in the Conserved Transcriptional Response to Adversity was seen with greater neighborhood disadvantage. "These findings support a potential link between neighborhood factors and stress-related pathways, which may in turn contribute to an increased risk of aggressive prostate cancer," the authors write. One author disclosed ties to the pharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.