Male Breast Neoplasms

– Study findings to be presented at the 2024 ASCO Annual Meeting find hereditary risk for gastric and lung cancers, among others, underscoring the need for broader genetic testing – SAN FRANCISCO, May 23, 2024 /PRNewswire/ -- Invitae (OTC:NVTAQ), a leading medical genetics company, today announced eight studies to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 31-June 4, 2024. The clinical data being presented demonstrate the importance of genetic testing for patients with various different types of cancers, including breast, gastric, prostate and lung, to better inform management and treatment decisions. Genetic testing guidelines need to be inclusive of more cancer types, with new data finding gastric, lung and prostate cancer patients with inherited genes linked to increased cancer risk Gastric cancer is the fourth leading cause of cancer-related deaths worldwide, and the role of pathogenic (disease causing) variants in cancer predisposition genes is not well understood for this disease. One study looked at genetic testing results in 3,706 gastric cancer patients – the largest study of its kind – to better understand the prevalence of disease causing variants in cancer associated genes. The results found the percentage of patients with disease causing variants to be 13.4%, about 1 in 8 patients. This shows the value of genetic testing in all gastric cancer patients, as the prevalence of pathogenic variants is similar to other cancer types for which guidelines recommend universal genetic testing. "Current guidelines haven't met the needs for patients across cancer types, gastric cancer included," said Dr. Ophir Gilad, University of Chicago and a co-author of this study. "The prevalence of actionable gene variants found in this study of gastric cancer patients is on par with other cancer types for which guidelines recommend universal genetic testing. We're increasingly seeing evidence for germline genetic testing to help guide treatment plans and familial testing for various cancer types." Additionally, in a study of 14,317 patients with lung cancer, 12.6% had pathogenic germline variants -- regardless of smoking history. The study results suggest these inherited genes are not only independently associated with lung cancer, but also additive to smoking risk for lung cancer. These data reinforce prior studies supporting consideration of germline genetic testing for all patients with lung cancer, independent of age or reported smoking history. Genetic testing is similarly underutilized for prostate cancer. In a large study of 15,000 prostate cancer patients that received genetic testing, results showed that of the patients with genetic variants that increase risk of prostate cancer, 3 in 4 patients had no reported family history of prostate cancer and more than 1 in 3 patients had no reported family history of any cancer. The findings underscore the importance of genetic testing for all prostate cancer patients, regardless of age, stage or family history. Breast cancer data in Rwanda demonstrates need for more genetic testing in underrepresented populations Despite the observation that cancers are often diagnosed at young ages and take an aggressive course in Sub-Saharan Africa (SSA), genetic data that could inform treatment are limited for this population group. In a recent study, patients undergoing cancer treatment in hospitals in Rwanda for female breast, male breast and prostate cancer underwent multigene panel testing (Invitae), and the results found a large proportion of the patients had inherited pathogenic variants that could help inform their treatment (18.3% of female breast cancer, 16.7% of male breast cancer, and 4.3% of prostate cancer patients). The findings suggest that genetic testing should be more routinely implemented into cancer care and prevention strategies in this population. Underrepresented race, ethnicity, and ancestry (REA) groups face these challenges across geographies. In another recent study being presented at ASCO that included more than one million people over an eight-year period who underwent genetic testing for hereditary cancer syndromes, it was found that underrepresented REA groups are disproportionately impacted by variants of uncertain significance (VUS) in genetic testing, which are uncertain results that are not clinically actionable. With more representation of these groups in clinical studies, there will be more data that could uncover life-saving discoveries. Clinical evidence was the most significant source of information leading to VUS resolution, underscoring the importance of the clinician-lab partnership and communication. "Germline genetic testing should be the standard of cancer care across many types of cancers. In underrepresented populations, this is especially crucial as more information needs to be collected to better inform care and improve population health overall," said Dr. Michael Korn, chief medical officer at Invitae. "Each year, ASCO presents us with an opportunity to share compelling research to help propel cancer treatment forward, and we're proud of the clinical insights our tests are able to provide across cancer types." Study offers reassurance that variants of uncertain significance in genetic testing results among patients with breast cancer do not lead to overuse of treatment or surveillance interventions, such as mastectomies It's common for patients with breast cancer undergoing germline genetic testing to have uncertain results, but it's previously been unclear if these results impact clinical management. However, a recent study being presented at ASCO presents new evidence indicating that variants of uncertain significance (VUS) identified through germline genetic testing do not result in guideline-discordant management in real-world settings. Specifically, patients with breast cancer and VUS results demonstrated similar rates of treatment, prevention and surveillance interventions compared to those with negative results. This offers reassurance that VUS results do not lead to overuse of mastectomies or other interventions for patients with breast cancer. 2024 ASCO presentations and posters: Oral presentation/Abstract 10513: Titled: Tracking uncertainty in germline genetic testing for hereditary cancer syndromes: Sources, attributes and resolution of variants of uncertain significance in over 1 million individuals. Presenter: Brian Reys, MS, CGC Oral presentation/Abstract 10512: Titled: Real-world cancer care utilization among patients with breast cancer with germline variants of uncertain significance. Presenter: Allison W. Kurian, MD, MS, MSc, FASCO Poster 374/Abstract 6058: Titled: The combination of patient-specific tumor and HPV sequencing to enable high-sensitivity detection of ctDNA in patients with HPV-associated oropharyngeal carcinoma. Presenter: Bill Diplas, MD, PhD Poster 106/Abstract 10579: Titled: Uptake of risk-reduction, surveillance and therapeutic interventions among breast cancer patients with pathogenic germline variants. Presenter: Allison W. Kurian, MD, MS, MSc, FASCO Poster 508/Abstract 5102: Titled: Germline gene-specific associations in a large prostate cancer cohort. Presenter: Hiba Khan, MD, MPH Poster 105/Abstract 10578: Titled: Prevalence of pathogenic genetic variants in patients with gastric cancer ascertained through multi-gene panel testing. Presenter: Ophir Gilad, MD Poster 118/Abstract 10591: Titled: Germline sequence variation in Rwandan patients with breast and prostate cancer. Presenter: Achille Manirakiza, MD, MMed Poster 302/Abstract 8040: Titled: Smoking and pathogenic germline variants in patients with lung cancer. Presenter: Ed Esplin, FACMG, FACP, MD, PhD About Invitae Invitae (OTC: NVTAQ) is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae's genetics experts apply a rigorous approach to data and research, serving as the foundation of their mission to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. To learn more, visit invitae.com and follow for updates on LinkedIn, X, Instagram, and Facebook @Invitae. Safe Harbor Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's beliefs regarding its new research; the company's belief that its new research demonstrates the importance of genetic testing for many cancers not currently covered by clinical guidelines; the company's belief that its new research demonstrates the need for more research in underrepresented populations; and the company's belief that its research helps move cancer treatment forward.. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the applicability of clinical results to actual outcomes; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; risks and uncertainties regarding the company's ability to successfully consummate and complete a plan under chapter 11 or any strategic or financial alternative as well as the company's ability to implement and realize any anticipated benefits associated with its sale of assets to Labcorp and the any alternative that may be pursued, including the asset sales and wind down of operations; the company's public securities' potential liquidity and trading; and any impact resulting from the delisting of the company's common stock from the New York Stock Exchange and trading instead on the OTC Pink Marketplace; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements. Invitae PR contact: Renee Kelley [email protected] SOURCE Invitae Corporation

Studies to Be Presented at the United States and Canadian Academy of Pathology (USCAP) Annual Meeting Brigham and Women's Hospital and Champalimaud Foundation research shows high accuracy levels of Galen Breast in identifying microinvasive carcinoma of the breast. University of Pittsburgh Medical Center study demonstrates pathologists' high performance when using Galen Prostate to support primary diagnosis in a live clinical setting. Ohio State University Wexner Medical Center studies show high accuracy for Galen Breast and Galen Gastric in detecting and distinguishing between different types of cancer and in identifying multiple important pathologies. BOSTON, March 21, 2024 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced excellent results across multiple clinical studies conducted with the University of Pittsburgh Medical Center (UPMC), Brigham and Women's Hospital, Champalimaud Foundation and Ohio State University (OSU). These studies, highlighting the value of Ibex's AI-powered cancer diagnostics solutions in both diagnostic quality and efficiency, will be presented next week at the United States and Canadian Academy of Pathology (USCAP) Annual Meeting. Cancer incidence is rising around the world while its diagnosis becomes more complex and nuanced in an era of precision medicine, in which accurate diagnosis is key for enabling personalized and tailored therapies. Increasing demand and diagnostic workloads are compounded by a global shortage of pathologists who still rely heavily on manual work requiring visual analysis of biopsies. Ibex's Galen™ platform helps overcome these challenges with Artificial Intelligence (AI)-powered workflows and decision-support tools that pathologists use in their everyday practice. A study conducted at Brigham and Women's Hospital and Champalimaud Foundation evaluated Galen Breast's performance in identifying microinvasive carcinoma of the breast in a challenging patient cohort. Microinvasive carcinoma is defined as the focus of invasive breast cancer no larger than 1mm, in which accurate detection has important implications for patient management. The results indicate that Galen Breast's AI algorithm is highly accurate in detecting microinvasive lesions and has the potential to improve consistency in diagnosis and support more efficient workflows in pathology laboratories. "Microinvasive carcinoma is challenging and time-consuming to identify, and is often subject to overdiagnosis and underdiagnosis, adversely affecting treatment decisions. Therefore, Galen Breast's accuracy in detecting and classifying these minute tumors is a vital step forward in enhancing diagnostic confidence and providing oncologists with a comprehensive pathology diagnosis," said Stuart Schnitt, MD, Chief of Breast Oncologic Pathology at the Dana-Farber/Brigham Cancer Center, and an investigator in the study. In another study conducted at UPMC, researchers assessed Galen Prostate's performance in primary diagnosis of prostate biopsies. The study found the AI-powered solution was highly accurate in identifying and grading cancer in a live clinical setting, with NPV and PPV of 0.991. The study also demonstrated positive feedback from participating pathologists, showing high satisfaction, particularly with Galen Prostate's Gleason scoring, detection of perineural invasion and automated measurement of tissue and tumor length. In addition, researchers from OSU Wexner Medical Center will present studies validating Galen Breast's performance in detecting different types of breast cancer. This includes invasive and in situ carcinoma, as well as other clinically important pathologies, such as lobular neoplasia and microcalcifications across a diverse cohort of breast biopsies. They will also present a study validating the performance of Galen Gastric in the diagnosis of gastric cancer, neuroendocrine tumors, H.pylori and other gastric lesions, such as adenoma and low-grade dysplasia. "Galen offers an unparalleled breadth of detection capabilities going well beyond cancer and becoming an integral part of everyday clinical practice in laboratories, hospitals and health systems globally," said Dr. Chaim Linhart, Chief Technology Officer and Co-Founder of Ibex Medical Analytics. "With these outstanding outcomes achieved in leading US healthcare institutions across various tissue types, amplified by very positive user feedback, our technology continues to set the standard for AI solutions in pathology, helping clinicians improve patient outcomes." Ibex will be showcasing these findings at the USCAP Annual Meeting taking place in Baltimore, Maryland, between March 23 to 28, at booth number 755. About Ibex Medical Analytics Ibex Medical Analytics (Ibex) is transforming cancer diagnostics with world-leading clinical grade AI-powered solutions for pathology. Empowering physicians and supporting pathologists, Ibex is on a mission to provide accurate, timely and personalized cancer diagnosis for every patient. Ibex's Galen™ is the first and most widely deployed AI-powered platform in pathology and demonstrated outstanding outcomes in multiple clinical studies2,3,4,5,6. Pathologists worldwide use Galen as part of their everyday routine practice to improve the accuracy of cancer diagnosis, implement comprehensive quality control measures, reduce turnaround times and boost productivity with more efficient workflows. For additional company information, please visit and follow us on LinkedIn and X. The Galen™ platform includes solutions which are for Research Use Only (RUO) in the United States and not cleared by the FDA. Multiple Galen solutions are CE marked (IVDD and IVDR) and registered with the UK MHRA. For more information, including indication for use and regulatory approval in other countries, contact Ibex Medical Analytics. Ibex Media Contact Nechama Rosengarten FINN Partners [email protected] [1] NPV and PPV are statistical terms which define the precision of a diagnostic test in detecting a relevant feature. [2] Sandbank et al., Validation and real-world clinical application of an artificial intelligence algorithm for breast cancer detection in biopsies, npj Breast Cancer, December 2022 [3] Pantanowitz et al., An artificial intelligence algorithm for prostate cancer diagnosis in whole slide images of core needle biopsies: a blinded clinical validation and deployment study, THE LANCET Digital Health Aug 2020 [4] Rodriguez-Justo et al., Multi-Site Multi Reader Study on Artificial Intelligence-Assisted Primary Diagnosis of Gastric Biopsies, Virchows Arch (2023) 483 (Suppl 1): S1 [5] Comperat et al., Clinical Level AI-Based Solution for Primary Diagnosis and Reporting of Prostate Biopsies in Routine Use: A Prospective Reader Study, European Congress of Pathology 2021 [6] Raoux et al., Novel AI-Based Solution for Supporting Primary Diagnosis of Prostate Cancer Increases the Accuracy and Efficiency of Reporting in Clinical Routine, USCAP 2021 SOURCE Ibex Medical Analytics

TUESDAY, June 6, 2023 -- Few patients diagnosed with cancer between 2013 and 2019 in California and Georgia underwent germline testing, according to a study published online June 5 in the Journal of the American Medical Association to coincide with the annual meeting of the American Society of Clinical Oncology, held from June 2 to 6 in Chicago. Allison W. Kurian, M.D., from the Stanford University School of Medicine in California, and colleagues assessed the prevalence of germline genetic testing among 1.37 million patients (aged 20 years and older) diagnosed with cancer in California and Georgia from 2013 to 2019. The researchers found that 6.8 percent of cancer patients underwent germline testing within two years of cancer diagnosis. There was variance by cancer type: male breast (50 percent), ovarian (38.6 percent), female breast (26 percent), multiple (7.5 percent), endometrial (6.4 percent), pancreatic (5.6 percent), colorectal (5.6 percent), prostate (1.1 percent), and lung (0.3 percent). Patients of other races and ethnicities underwent testing less often than the 31 percent of non-Hispanic White patients with male breast cancer , female breast cancer, or ovarian cancer who underwent testing (22 percent of Asian patients, 25 percent of Black patients, and 23 percent of Hispanic patients). “Although testing failed to meet practice guidelines, it increased substantially over time,” write the authors. Several authors disclosed financial ties to genetic testing companies. Abstract/Full Text Editorial More Information Posted June 2023