GE Healthcare and Lantheus Phase III Clinical Trial Finds [18F]flurpiridaz PET Radiotracer Could Improve Detection of Coronary Artery Disease
13.9.2022 15:05:00 EEST | Business Wire | Press release
GE Healthcare and Lantheus Holdings Inc (NASDAQ: LNTH) have announced that the recent Phase III clinical trial of their investigational radiotracer, [18F]flurpiridaz, has met its co-primary endpoints of exceeding a 60 percent threshold for both sensitivity and specificity for detecting Coronary Artery Disease (CAD). The findings, shared at the American Society of Nuclear Cardiology (ASNC) Congress, in Florida, U.S., also demonstrate [18F]flurpiridaz Positron Emission Tomography (PET) has higher diagnostic efficacy and image quality in patients with suspected CAD, compared with Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI), the predominant procedure used in nuclear cardiology today. SPECT MPI represents approximately 6 million procedures per year in the U.Si.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220913005138/en/
The Phase III Open-Label Study, which involved over 600 patients across sites in the U.S., Europe and Canada assessed the diagnostic efficacy of [18F]flurpiridaz in detecting CAD, the most common form of heart diseaseii and the leading cause of death globallyiii, with invasive coronary angiography as a standard of truth. More than 120 million people are affected by CAD globally each yeariv and in the U.S. alone, approximately 20 million adults have CAD, with nearly 383,000 deaths recorded in 2020v.
If approved, this investigational agent would offer the advantages of 18F, with broad available distribution and a half-life of almost two hours, removing the need for it to be manufactured in the immediate vicinity of the imaging department. This longer half-life could also make Flurpiridaz (18F) Injection suitable for exercise stress testing, which is not feasible with existing cardiac PET radiotracers.
Dr. Tim Bateman, MD, FACC, co-director of the Cardiovascular Radiologic Imaging Program at Saint Luke's Hospital, Missouri, US, shared: “These results are truly promising for the nuclear cardiology community and CAD patients. From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view [18F]flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.”
Dr. Francois Tranquart, MD, PhD, Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, Research and Development, said: “The positive Phase III trial results are a key step towards future approval of Flurpiridaz (18F) Injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease. This is another example of GE Healthcare investing in our portfolio of Molecular Imaging products to help improve diagnostic accuracy and patient outcomes.”
GE Healthcare has led the funding and development of [18F]flurpiridaz, and, if the imaging agent is approved, will have global commercialization rights. Lantheus has collaborated on the development and will also collaborate on potential commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales.
GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patients every second. Its Molecular Imaging portfolio combines an innovative pipeline with established proprietary products across cardiology, neurology and oncology.
About GE Healthcare:
GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 48,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
Follow us on Facebook, LinkedIn, Twitter, and Insights for the latest news, or visit our website www.gehealthcare.com for more information.
About Lantheus
With more than 60 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus is headquartered in Massachusetts and has offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
###
i Data on File: AMR Market Guide 2021.
ii WHO Factsheet 2020. Cardiovascular diseases (CVDs). 11 June 2021.
iii Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.
iv Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.
v Centers for Disease Control and Prevention. Heart Disease Facts. Accessed July 15 2022.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220913005138/en/
Contact information
GE
Healthcare Media Contact:
Debbie Leven
Debbie.Leven@ge.com
+44 7785 456999
Lantheus Contacts:
Investors
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Media
Melissa Downs
Senior Director, Corporate Communications
646-975-2533
media@lantheus.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Sharjah Unveils Uruk: A New Generation of Sustainable Cities Built for the Post-AI Era29.10.2026 20:15:00 EET | Press release
In the presence of His Highness Sheikh Dr. Sultan bin Mohammed Al Qasimi, Supreme Council Member and Ruler of Sharjah, and Her Highness Sheikha Bodour bint Sultan Al Qasimi, President of American University of Sharjah and Chairperson of Sharjah Research, Technology and Innovation Park, a pioneering model for a new generation of cities designed for the post-AI era called “Uruk.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029129346/en/ H.H. Sheikh Dr. Sultan bin Mohammed Al Qasimi, Ruler of Sharjah, during the inauguration of “Uruk” (Photo: AETOSWire) The project was revealed at the opening of the second edition of Sharjah Next, through a strategic partnership between Sharjah Research, Technology and Innovation Park (SPARK), American University of Sharjah (AUS) and SEE Holding, bringing together their capabilities in innovation, scientific research and sustainable urban development. Uruk introduces a new vision for urba
Motive and Vivo Brazil Win 2026 Leading Lights Award for Network API Monetization29.10.2026 18:35:00 EET | Press release
Motive, a global leader in entitlement, connected device and service management and Vivo Brazil, Brazil’s largest operator and part of the Telefónica Group, have won the 2026 Light Reading Leading Lights Award for Outstanding Use Case: Network API Monetization for the first commercial scale deployment of SIM-based silent authentication in Latin America. SMS OTP remains relevant as an authentication method due to its broad reach, working on virtually any type of mobile device. SIM-based silent authentication takes this experience a step further by eliminating the need to receive and manually enter codes. The result is a simpler, more seamless user journey that reduces friction and can help lower abandonment rates while increasing customer conversion and retention. Using Motive’s CAMARA-compliant Entitlement Server, Vivo can now verify a subscriber’s phone number directly without requiring a passcode over mobile networks. The business value is straightforward: a simpler authentication ex
REV Ocean Appoints Paul Baribault as CEO Ahead of 2027 Global Operations29.10.2026 16:45:00 EET | Press release
REV Ocean has appointed Paul Baribault as Chief Executive Officer as the organization moves towards the international debut of its 195-metre research vessel in Rio de Janeiro in April 2027, alongside the UN Ocean Decade Conference. One of the world's largest privately owned research and exploration vessels, REV represents a major philanthropic investment in ocean science. With nine laboratories, advanced deep-sea exploration vehicles and dedicated collaboration facilities, it is designed to give scientists access to world-class research infrastructure and connect their discoveries with the people and institutions able to drive ocean protection. Baribault joins as REV Ocean moves from a decade of engineering and construction into international operations. His mandate will be to build the international partnerships, funding base and organization needed to turn REV Ocean’s scientific capabilities into lasting ocean impact. An experienced conservation and nonprofit leader, Baribault served
Holder Partners Launches Strategic Communications Practice and Appoints Ali Ponte as Director and Practice Lead29.10.2026 16:15:00 EET | Press release
Holder Partners, a multidisciplinary consulting and advisory firm, today announced the launch of its Strategic Communications practice and the appointment of Ali Ponte as Director and Practice Lead. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027701219/en/ Ali Ponte, Director and Practice Lead of Holder Partners’ Strategic Communications practice. The practice advises leading companies and institutions, their boards, senior executives and counsel on communications, reputation and stakeholder considerations in complex matters and periods of significant change or opportunity. Each engagement is tailored to the client’s objectives and, where relevant, draws on Holder Partners’ broader advisory capabilities. Its strategic counsel, informed by research and analysis, helps clients assess the implications of a matter, anticipate stakeholder responses and communicate clearly and effectively. That work includes crisis preparedn
Accertify Formalizes Partner Ecosystem as Fraud, Payments, and Chargebacks Converge Into a Single Risk Surface29.10.2026 16:00:00 EET | Press release
Accertify, a leading fraud decisioning provider whose Predictive Yes Platform helps merchants say yes to more good customers, more revenue, and more growth, today announced the launch of the Accertify Partner Program, a formalized partnership ecosystem connecting payment providers, orchestrators, commerce platforms, and consultancies to Accertify’s network-powered fraud intelligence. Partners can join through two tracks. The Referral track lets partners make a single introduction while Accertify handles the sale, implementation, and support. The Reseller track lets partners sell Accertify on their own contract and own the client relationship and margin. Partners that integrate with Accertify follow a defined certification path, so clients get a tested, supported connection from day one. Every client a partner brings joins a consortium where good customers verified anywhere in the network get through faster everywhere, and bad actors seen anywhere are stopped everywhere. In 2025, Accert
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom