Protein-Energy Malnutrition

– Helps to detect circulating tumor DNA (ctDNA) as a biomarker in clinical research and clinical trials for solid tumor malignancies – – May provide real-time data on therapy response, support patient prognostic stratification and enable early detection of residual disease – SAN FRANCISCO, Nov. 6, 2023 /PRNewswire/ -- Invitae (NYSE: NVTA), a leading medical genetics company, today announced enhanced chemistry of its Invitae Personalized Cancer Monitoring™ platform that helps detect circulating tumor DNA (ctDNA) as a biomarker for solid tumor malignancies. ctDNA can provide real-time insights on patient response or disease progression, support patient prognostic stratification and enable early detection of residual disease. The enhanced assay, which received Clinical Laboratory Improvement Amendments (CLIA) approval, features a flexible patient-specific panel design of between 18 and 50 variants, demonstrating a sensitivity of >99% for detecting ctDNA at variant allele frequencies as low as 0.005%. In addition, the company has also received CLIA approval on the whole exome sequencing component of PCM as a stand-alone comprehensive genomic profiling (CGP) assay to permit reporting of tumor profiles. In our commitment to continual innovation, the enhanced assay achieves a number of benefits. Compared to our prior version, the enhanced assay permits a new lower mass input limit that results in the same sensitivity as the prior version with less cell-free DNA (cfDNA), enabling Invitae to test samples that might have been previously rejected. The enhanced assay also involves fewer steps that will increase capacity and reduce the burden of materials and labor costs. Lastly, the enhanced chemistry is automation friendly enabling scale and supporting future growth. "This focused launch and enhanced chemistry will enable biopharma partners to detect recurring disease early," said Bob Daber, Ph.D., chief scientific officer of Invitae. "This will potentially help set MRD as a standard practice in clinical studies and increase the velocity of drug development. Our vision is that insights gained from Invitae Personalized Cancer Monitoring will lead to research breakthroughs that positively influence patient journeys." "With Invitae Personalized Cancer Monitoring, biopharma researchers will have information they need to inform clinical trial design and study patient outcomes, ultimately to help bring new cancer therapies that benefit patients to market," added Dr. Daber. To learn about Invitae Personalized Cancer Monitoring, please contact [email protected]. About Invitae Personalized Cancer Monitoring™ Invitae Personalized Cancer Monitoring is a multi-cancer, tumor-informed, long-term monitoring assay that incorporates next-generation sequencing libraries featuring both unique molecular identifiers (UMIs) and updated anchored multiplex PCR (AMP) chemistry. Invitae Personalized Cancer Monitoring provides personalized ctDNA detection and quantitation from the peripheral blood in patients with solid tumors. Biopharma researchers can utilize the validated Invitae Personalized Cancer Monitoring platform to detect residual cancer at the molecular level. By assessing the presence and levels of ctDNA over time, Invitae Personalized Cancer Monitoring provides a highly sensitive approach to detect residual cancer in patients who have undergone surgery and other definitive therapies, thus informing further diagnostic and therapeutic decisions, leading to potentially improved outcomes. The assay can also provide molecular information on the extent of response to therapeutic interventions, in various clinical settings, which may assist in optimizing clinical studies and accelerating drug development. Currently established clinical practice involves utilizing imaging as a means to detect residual disease and tumor changes, which might result in delayed detection of disease recurrence and inaccurate assessment of therapeutic response. Biopharma researchers need a faster and more reliable way to understand therapeutic responses to novel drug regimens. The Invitae Personalized Cancer Monitoring assay may provide such information. For example, in a study of non-small cell lung cancer, a ctDNA assay based on the Invitae Personalized Cancer Monitoring platform detected relapse prior to standard clinical diagnosis via imaging by almost four months. About Invitae Invitae (NYSE: NVTA) 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 Twitter, Instagram, Facebook and LinkedIn @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 potential benefits of the enhanced chemistry of the Invitae Personalized Cancer MonitoringTM test; that the company's focused launch and enhanced chemistry will enable biopharma partners to detect recurring disease early, potentially help set MRD as a standard practice in clinical studies and increase the velocity of drug development; and the company's vision that insights gained from its test will lead to research breakthroughs that positively influence patient journeys. 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 company's ability to grow its business in a cost-efficient manner; the company's history of losses; the company's ability to maintain important customer relationships; the company's ability to compete; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the applicability of clinical results to actual outcomes; risks associated with litigation; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; 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 June 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

CARLSBAD, Calif., Dec. 15, 2022 /PRNewswire/ -- ImpediMed Limited (ASX: IPD) is pleased to announce a poster showing that breast cancer patients receiving early detection of lymphedema using ImpediMed's L-Dex® technology and intervention had statistically higher rates of lymphedema progression-free survival through three years compared to using tape measure was presented at the 2022 San Antonio Breast Cancer Symposium on December 6-10, 2022 in San Antonio, Texas. Continue Reading L-Dex monitoring with intervention translated into lower risk of chronic breast cancer-related lymphedema Tweet this New Data Presented at the 2022 San Antonio Breast Cancer Symposium Shows Early Detection using L-Dex and Intervention Improves Lymphedema Progression-Free Survival The poster, titled "Bioimpedance spectroscopy monitoring reduces long-term clinical lymphedema risk" includes a Kaplan-Meier analysis of data from the PREVENT Trial to assess lymphedema progression-free survival in breast cancer patients who triggered for subclinical lymphedema and received intervention (n=209). The analysis showed that there were statistically higher rates of lymphedema progression-free survival in patients screened for subclinical lymphedema using L-Dex compared to using tape measure, p = 0.021. "L-Dex monitoring for subclinical lymphedema with subsequent intervention translated into significantly lower risk of chronic lymphedema in breast cancer patients compared to monitoring with tape measure and intervention," commented Dr. Chirag Shah, Director of Breast Radiation Oncology and Director of Clinical Research in the Department of Radiation Oncology at Cleveland Clinic, co-investigator of the PREVENT Trial, lead author on the poster, and scientific adviser to ImpediMed. He continued, "Chronic lymphedema is a serious side effect of breast cancer treatment that dramatically impacts patients' quality of life in survivorship. The results of this poster further reinforce the need for long-term monitoring of breast cancer patients for subclinical lymphedema following cancer treatment since progression to chronic lymphedema occurred throughout the three-year follow-up period." The primary aim of the PREVENT Trial was published in January 2022 and demonstrated that patients with early detection using L-Dex and at-home intervention with compression garments resulted in a 7.9% rate of chronic lymphedema compared to a 19.2% rate of chronic lymphedema using tape measure. The difference is statistically significant (p=0.016) as well as being clinically significant for patients and clinicians. This represents an absolute reduction of 11.3% and relative reduction of 59% in lymphedema progression at three years. The primary aim paper also included a risk-adjusted analysis, which showed a significantly consistent benefit of L-Dex monitoring in a large group of patients with key risk factors for breast cancer-related lymphedema including body weight, stage of cancer, type of cancer surgery, lymph node dissection, chemotherapy, and radiation (odds ratios: 0.23-0.39). Today, L-Dex is the only non-invasive, reliable, validated tool to help clinicians identify subclinical lymphedema. Monitoring L-Dex scores allows clinicians across multiple specialties to provide individualized, proactive care that can help improve patient outcomes. To learn more about the PREVENT Trial, visit . About Lymphedema Lymphedema is a side effect of cancer treatment. It currently affects about 1-in-3 patients who have undergone surgery, radiation, or chemotherapy, each of which may compromise the lymphatic system. Lymphedema is characterized by abnormal swelling that generally occurs in one of the arms or legs, and sometimes both arms and both legs. Patients with lymphedema also have a greater risk of getting infections. Cuts or small breaks in the skin can lead to serious complications and hospitalizations. Currently, no cure for lymphedema exists. By the time patients experience swelling, the condition is typically irreversible. However, extensive research indicates that prevention is possible if lymphedema is caught early and ImpediMed's L-Dex technology, which is available on the SOZO® Digital Health Platform, has the most extensive evidence of efficacy for early detection. For more information, visit preventlymphedema.com. About ImpediMed Founded and headquartered in Brisbane, Australia with US and European operations, ImpediMed is a medical software technology company that non-invasively measures, monitors, and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS). ImpediMed produces a family of FDA cleared and CE Marked medical devices, including the SOZO® Digital Health Platform for multiple indications including heart failure, protein calorie malnutrition and lymphedema, sold in select markets globally. For more information, visit impedimed.com. Media Contact: [email protected] SOURCE ImpediMed

CARLSBAD, Calif., Nov. 16, 2022 /PRNewswire/ -- ImpediMed Limited (ASX: IPD) today announced the details of the third contract extension related to the use of its SOZO® Digital Health Platform in a clinical trial being conducted for AstraZeneca. The Phase IIb trial uses SOZO to track patient fluid volume in a pharmaceutical study focused on patients with chronic kidney disease. The trial, involving 210 SOZO devices, has been extended from 21 months to 29 months. Continue Reading The Phase IIb trial is designed to evaluate the efficacy, safety and tolerability of a combination of two AstraZeneca drugs in patients with chronic kidney disease. This Phase IIb trial began in November 2020 and the use of SOZO within the trial is now scheduled to be completed in April 2023. The trial is being run by a contract research organization on behalf of AstraZeneca. The pharmaceutical trial uses SOZO to track patient fluid volume in patients with chronic kidney disease. Tweet this The Company previously announced AstraZeneca is using SOZO to track patient fluid volume in two separate clinical trials. A combined 434 SOZO devices have been leased across over 28 countries over the course of both trials. The first trial was focused on heart failure and chronic kidney disease and the second only on chronic kidney disease. The use of SOZO in the initial trial is now complete. About SOZO Digital Health Platform SOZO, the world's most advanced, noninvasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed's BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart failure, and can be used to monitor and maintain overall health – all on a single platform. For more information, visit About ImpediMed Founded and headquartered in Brisbane, Australia with US and European operations, ImpediMed is a medical software technology company that non-invasively measures, monitors, and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS). ImpediMed produces a family of FDA cleared and CE Marked medical devices, including the SOZO® Digital Health Platform for multiple indications including heart failure, protein calorie malnutrition and lymphedema, sold in select markets globally. For more information, visit Media Contact: [email protected] SOURCE ImpediMed