National Institute For Biomedical Imaging And Bioengineering (Nibib)

WEST CHESTER, PA, USA I December 09, 2024 I Molecular Targeting Technologies, Inc. (MTTI) published preclinical study results for their proprietary 225 Ac-EBTATE against SSTR2 NET cancers online in the European Journal of Nuclear Medicine. (“Long acting 225 Ac-EBTATE is highly efficacious against somatostatin receptor-2-positive neuroendocrine tumors” ( https://rdcu.be/d2lCG ). Professor Humphrey Fonge of the Université de Laval and lead author commented, “At just 40% of the administered dose reported for 225 Ac-DOTATATE, 225 Ac-EBTATE produces enhanced anti-tumor efficacy in Small Cell lung cancer (SCLC) and Pan-neuroendocrine tumor (NET) models as shown with complete tumor remissions. At a therapeutic dose of 2x 34 kBq, 225 Ac-EBTATE showed general safety for 28 days after blood biochemistry analysis, CBC, and histopathological examination of major organs and tissues. We demonstrated that 225 Ac-EBTATE was effective against human small-cell lung cancer (SCLC) with 80% complete remission and 100% survival in preclinical models.” MTTI has licensed commercial use rights for the patented Evans blue (EB) technology from the National Institute of Biomedical Imaging and Bioengineering (“ NIBIB ”), part of the National Institutes of Health (“ NIH ”). This platform is the basis for the best-in-class, new generation, collection of targeted radiopharmaceuticals (TRP). EB binds to serum albumin, extending in vivo circulatory half-life and tumor residence time, enhancing up to 30-fold uptake at a tumor and enabling good efficacy with significantly lower radiopharmaceutical activity and fewer dosing cycles vs. the current standard of care. Our 3-year follow up of 177 Lu-EBTATE in patients* (N=30) with metastatic neuroendocrine tumors, demonstrated good safety with no nephro- or hepatoxicity and 86% disease control rate using only 40% of the administered dose of 177 Lu-DOTATATE. Dr. Jean-Mathieu Beauregard, MD, Associate Professor of Department of Radiology of Université Laval, said, “I am encouraged to see the positive results of 225 Ac-EBTATE in treating small cell lung cancer and Pan-neuroendocrine tumor (NET) in preclinical studies. I look forward to working with MTTI and Professor Fonge to translate this into the clinic.” Dr. Chris Pak, President & CEO of MTTI commented “ 225 Ac-EBTATE effectiveness was encouraging, paralleling the clinical superiority of 177 Lu-EBTATE. We look forward to collaborating with Professors Beauregard and Fonge to drive 225 Ac-EBTATE into clinical trials in 2025.” Molecular Targeting Technologies, Inc. (MTTI) . Molecular Targeting Technologies, Inc. is a private, clinical stage biotech developing targeted radiopharmaceuticals (TRP) for rare cancers. MTTI is committed to building value by translating innovative TRP to improve human health. For more information: www.mtarget.com . *Jiang Y, Liu Q, Wang G, et al. Safety and efficacy of peptide receptor radionuclide therapy with 177 Lu-DOTA-EB-TATE in patients with metastatic neuroendocrine tumors. Theranostics. 2022;12(15):6437-6445. SOURCE: Molecular Targeting Technologies Inc

Healgen Scientific receives FDA De Novo Authorization for 2-in-1, at-home respiratory illness test by leveraging CovarsaDx's clinical expertise LOS ANGELES, Oct. 9, 2024 /PRNewswire/ -- CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in vitro diagnostics (IVDs) and medical devices, proudly announced today that a clinical research study, conducted on behalf of Healgen Scientific, LLC, through the Independent Test Assessment Program (ITAP), part of National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech, has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for the Healgen Rapid Check® COVID-19/Flu A&B Antigen Test. Continue Reading "Through our partnership with CovarsaDx, we were able to leverage their extensive clinical expertise and resources from meticulous study planning to execution," said Bryan Fang, president of Healgen Scientific, LLC. CovarsaDx®'s clinical research study, on behalf of Healgen Scientific, has received De Novo marketing authorization. Post this CovarsaDx's clinical research efforts supported Healgen, an innovator in diagnostic solutions, in receiving full clearance of an at-home test that simultaneously detects and differentiates COVID-19, influenza A, and influenza B infections with a single nasal swab. With the next respiratory season soon approaching, this cutting-edge solution will enable individuals to get results in minutes and help determine whether their symptoms are due to COVID-19, influenza A, or influenza B, ensuring timely and informed healthcare decisions. "CovarsaDx has been part of the ITAP initiative since its inception, supporting efficient and effective clinical evaluations of products in the program through VentureWell's Clinical Evaluation Services program," says Rebekah Neal, VentureWell vice president for commercialization. "This De Novo marketing authorization for Healgen highlights the success of RADx Tech program and ITAP in speeding the production of home-based tests." This significant achievement underscores CovarsaDx's clinical expertise and highlights the company's ability to quickly and effectively help bring diagnostic tests from clinical validation to market, improving access to reliable testing. "As their trusted CRO, we are excited to work with Healgen and ITAP on this groundbreaking advancement," said Chermaen Lindberg, president and CEO of CovarsaDx. "This De Novo marketing authorization is an important milestone in diagnostic testing, enabling better access to detection for improved health outcomes." This project has been partly funded with federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract Nos. 75N92022D00010 and 75N92022D00013. Learn more at CovarsaDx.com. Click here for FDA press release. About CovarsaDx CovarsaDx is a leading clinical research organization specializing in in vitro diagnostics (IVDs) and medical devices. The company provides agile responses to patient population needs and fluctuations in regulatory requirements for rapid market pathways. Their team of regulatory, quality and clinical experts have extensive industry experience and consist of regulatory strategists, quality experts, study managers, monitors, data managers, and statisticians who work together to deliver reliable clinical results. Contacts Media: [email protected] Study Inquiries: [email protected] CovarsaDx® is a registered trademark of CovarsaDx Corporation. Rapid Check® is a registered trademark of Healgen Scientific, LLC. SOURCE CovarsaDx WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Healgen Rapid Check ® COVID-19/Flu A&B Antigen Test was supported through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx ® ) Tech program. HOUSTON, Oct. 8, 2024 /PRNewswire/ -- Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA's De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes. Continue Reading Combo Cassette The OTC Healgen Rapid Check® COVID-19/Flu A&B Antigen Test provides rapid, accurate and convenient detection of COVID-19, influenza A and influenza B infections. "Our combo test addresses a critical gap in clinical diagnostic testing by providing a reliable and user-friendly solution for individuals to test themselves at home," says Dr. Bingliang Fang, CEO of Healgen. "Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission." Validation of Healgen's at-home test data was supported through the Independent Test Assessment Program (ITAP), part of National Institutes of Health's (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program. ITAP assessed Healgen's Rapid Check COVID-19/Flu A&B Antigen Test's quality, accuracy and reliability, and found it demonstrated sensitivity and specificity of greater than 90% and 99%, respectively. "This De Novo marketing authorization for Healgen highlights the success of the RADx Tech program and ITAP in speeding the authorization of home-based tests, and will be an important part of the public health toolkit as we move into the fall respiratory virus season," says Rebekah Neal, VentureWell Vice President for Commercialization. "VentureWell is proud to have played a role in this collaboration as the NIH/NIBIB Innovation Funnel Commercialization Center." With a simple nasal swab, individuals can quickly determine whether their symptoms are due to COVID-19, Influenza A or Influenza B. This eliminates the need for multiple tests and reduces the burden on health care systems. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is authorized for individuals aged 14 years or older, or adult-collected samples from individuals aged 2 years or older, who are experiencing symptoms within the first five days. "This De Novo authorization represents a significant milestone for Healgen. With our existing state-of-art manufacturing facility, we plan to scale up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season," says Bryan Fang, president of Healgen. Healgen's dedication to quality and innovation is evident in the rigorous development and validation process that the Healgen Rapid Check COVID-19/Flu A&B Antigen Test has undergone. The test has been designed to meet the highest performance standards, including accuracy, reliability, and ease of use, ensuring that individuals can trust the results they receive. This project has been partly funded with federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract Nos. 75N92022D00010 and 75N92022D00013. About Healgen Healgen Scientific, LLC, dedicated to improving global health outcomes, is a leading provider of high-quality healthcare products and solutions. With a focus on innovation, quality and accessibility, Healgen develops and commercializes healthcare products and solutions that empower individuals and healthcare providers to make informed patient care decisions. Healgen's mission is to enhance global health and create a healthier world for all. For more information, please visit Healgen's website or contact [email protected] for media inquiries. The press release announcing the news is available on the FDA's website. Rapid Check® is a registered trademark of Healgen Scientific, LLC. RADx® is a registered trademark of U.S. Department of Health and Human Services. Logo - Photo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED