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...

Trending Now

China ropes in more countries for its COVID-19 vaccine trialsSeptember 29, 2020
Antarctica is still free of Covid-19. Can it stay that way?September 29, 2020
Over 200 travellers from India barred from Dubai flight over invalid Covid-19 testsSeptember 29, 2020
Netherland focuses on more stricker rule to comabt COVID-19 September 29, 2020
WHO aims to provide 120 Million rapid Coronavirus tests for poorer statesSeptember 29, 2020
UN chief on 1 Million COVID-19 deathsSeptember 29, 2020
Bahrain reports 585 Covid-19 cases, 777 recoveriesSeptember 28, 2020
Bringing hepatitis C testing and treatment to underserved communities in MadridSeptember 28, 2020
Polish doctor recovers from severe COVID-19 through rehabilitationSeptember 28, 2020
WHO supports rehabilitation of COVID-19 and other patients in UkraineSeptember 28, 2020
WHO work with migrant camps in Greece September 28, 2020
US employers being sued for COVID-19 infection spread September 28, 2020
Global Coronavirus deaths cross 1 Million markSeptember 28, 2020
Highly effective antibodies identified, may lead to passive COVID-19 vaccineSeptember 26, 2020
Europe has a lot of work to do to prevent COVID-19 transmission :WHOSeptember 26, 2020
Two million Coronavirus deaths : WHO September 26, 2020
Johnson & Johnson COVID-19 vaccine produces strong results September 26, 2020
New York to permanently switch to outdoor dining amid pandemicSeptember 26, 2020
WHO gave blessing for Coronavirus vaccine emergency use programme: ChinaSeptember 26, 2020
US surpasses 7 Million Coronavirus casesSeptember 26, 2020