US FDA Approves Roche's Elecsys GALAD Score to support earlier diagnosis of Cancer.

▴ US FDA Approves Roches Elecsys GALAD Score to support earlier diagnosis of Cancer
The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions

Roche recently announced that the U.S. FDA has granted Breakthrough Device Designation to the Elecsys GALAD score. This algorithmic score combines gender and age with the biomarker results of the Elecsys AFP, AFP-L3 and PIVKA-II and is intended to aid diagnosis of early stage hepatocellular carcinoma (HCC).

Dr. Amit Singal, Medical Director of the Liver Tumor Program and Clinical Chief of Pathology at UT Southwestern Medical Center in Dallas, USA, stated, "HCC is the fourth leading cause of cancer-related death worldwide, with the highest burden of disease in East Asia and Africa. This high mortality is largely driven by most patients being detected at a late stage, when curative therapies are no longer possible. Therefore, improving early HCC detection is a critical area of need."

The Elecsys GALAD score will be the first GALAD score, with regulatory approval, for use in In Vitro Diagnostics and is an integral part of the Roche Diagnostics Liver Indication Program, which aims to improve diagnostic workflows throughout chronic liver disease management. Combined with ultrasound, the Elecsys GALAD score has the potential to support clinicians by giving them more accurate information at an earlier stage, thus improving patient outcomes while being minimally invasive for people and potentially also more affordable to healthcare systems.

Liver cancer is one of the few cancers that are on the rise. While recent developments in screening and new treatments are making advances in the prevention, diagnosis and treatment of HCC, clinicians still face challenges in diagnosing the disease early enough. Only 44% of liver cancer patients are diagnosed at an early stage.3 Of HCC patients, which are diagnosed with late-stage disease, less than 16% survive a period of 5 years. Of the patients diagnosed at an early stage, 70% percent are still alive after five years. Therefore, diagnosing HCC, as early as possible, is essential to improving patient outcomes.

"We are excited about FDA’s recognition of the potential clinical benefit the Elecsys GALAD score could bring in diagnosing hepatocellular cancer at an early stage," said Thomas Schinecker, CEO of Roche Diagnostics. "The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce mortality of HCC patients as they can receive a more timely diagnosis and treatment."

Tags : #Roche #Livercancer #Hepatocellularcarcinoma

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Will India’s Healthcare Budget Support a Future of Robotic Surgeries?February 22, 2025
Is the World on the Brink of Another Pandemic? Scientists Discover a New Bat VirusFebruary 22, 2025
Newcastle University Expands Academic and Research Collaborations in IndiaFebruary 21, 2025
Get Ready to #BibaUp! Kriti Sanon Unveils the Season’s Most Stylish Summer CollectionFebruary 21, 2025
A Rare Condition: Surgery Saves 2-Day-Old Baby as Organs Shift Into ChestFebruary 21, 2025
Odisha’s Bold Healthcare Vision: A Rs 12,000 Crore Blueprint for Universal Health AccessFebruary 21, 2025
Young India’s Health Crisis: Why Insurance Claims Are Rising Among 25-35 Year OldsFebruary 21, 2025
India vs. Trump’s Pharma Tariff: The Battle Over Affordable MedicineFebruary 21, 2025
Foreign Medical Aspirants in Trouble: NMC’s Warning on Pending Eligibility CertificatesFebruary 21, 2025
Think Your Work Music Helps You Focus? Science Says Think AgainFebruary 21, 2025
Is Your Home’s Air Poisoning You? Shocking New Study Reveals Hidden Indoor Pollution RisksFebruary 20, 2025
The Society of Automotive Engineers & B V Raju Institution of Technology; to host the globally prestigious E-BAJA 2025; at Hyderabad!February 20, 2025
Eat right for your heart to beat rightFebruary 19, 2025
Aakash Healthcare and Medtronic Inaugurate North India’s First Dedicated Vein ClinicFebruary 19, 2025
Urgent and accelerated HIV service delivery with equity and rights is critical to end AIDSFebruary 19, 2025
Fasting Fad or Future Health Threat? Why Teens Should Think Twice Before Intermittent Fasting February 19, 2025
Public Hospitals Go High-Tech: AIIMS Delhi Leads India’s Robotic Surgery WaveFebruary 19, 2025
Screen Time and Healthy Habits: Navigating Optimal Development in ChildrenFebruary 18, 2025
SRM Global Hospitals Launches WOW, a Centre Exclusively for Women’s Health and WellnessFebruary 18, 2025
The Hidden Dangers of Scented Candles: Aesthetic Bliss or Silent Health Hazard?February 18, 2025