Trovagene’s ctDNA Liquid Biopsy urine and blood tests to be used in Monitoring and Early Detection of Pancreatic Cancer
Reporters: David Orchard-Webb, PhD and Aviva Lev-Ari, PhD, RN
UPDATED on 7/29/2016
Trovagene’s Dual-Sample Liquid Biopsy Performs Well in First Peer-Reviewed Study
Detection and quantitation of ctDNA KRAS mutations from patients with unresectable pancreatic cancer
Inna Chen 1 , Victoria M. Raymond 2 , Jennifer Geis 2 , Sandeep Pingle 2 , Fernando F. Blanco 2 Eric A. Collisson 3 , Vlada Melnikova 2 , Margaret Tempero 3 , Mark G. Erlander 2 , and Julia S. Johansen 1 1Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Denmark; 2Trovagene, Inc, San Diego, California, USA; 3Department of Oncology, University of California San Francisco, California, USA
Conclusions
• This is the largest, prospective dataset exploring ctDNA KRAS in unresectable pancreatic cancer.
• 92.9% of 210 patients with unresectable pancreatic cancer were positive for ctDNA KRAS.
• This detection rate closely matches the published prevalence of KRAS in pancreatic cancer (90%), and out performs previous studies, demonstrating the superior assay sensitivity.
• ctDNA analysis offers a viable tissue biopsy alternative for determining KRAS mutation status, especially in late stage patients.
• ctDNA KRAS analysis identified 52% more patients as positive than CA19-9, demonstrating KRAS as an improved diagnostic tool.
• Individuals with metastatic disease had a 8.2 fold difference in median ctDNA KRAS mutation load at baseline versus a 3.9 fold difference in baseline CA19-9. KRAS may represent an improved biomarker for metastatic disease over CA19-9.
• In two representative patients, dynamic changes in KRAS mutation load were consistent with response by imaging and predicted progressive disease months in advance of progression by imaging.
• Quantitation of KRAS mutant copy load may provide a more informative biomarker for prognosis and monitoring for therapeutic response
http://www.trovagene.com/wp-content/uploads/Posters/20160512%20AACR%20PancreasPoster(1).pdf
Trovagene and University of Michigan Enter into Collaboration for Monitoring and Early Detection of Pancreatic Cancer
Trovagene’s KRAS ctDNA liquid biopsy test will be at the forefront of research partnership with Dr. Diane Simeone at University of Michigan Health System
SAN DIEGO, July 6, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of circulating tumor DNA (ctDNA) molecular diagnostics, today announced the initiation of a multi-phased collaborative research program with the University of Michigan Comprehensive Cancer Center utilizing the Trovera™ KRAS ctDNA liquid biopsy test.
About Pancreatic Cancer and KRAS Mutations
The relative 1-year survival rate for patients with pancreatic cancer is only 28%, and the overall 5-year survival rate is 8%; stage IV pancreatic cancer has a 5-year survival rate of about 1%. At present, surgery offers the only therapeutic means of cure, but less than 20% of patients present with tumors amenable to resection.
The significant mortality rate of pancreatic cancer is due to the high incidence of metastases at the time of diagnosis, its fulminant clinical course, and the lack of adequate systemic therapies. Patients who undergo resection for localized pancreatic carcinoma have a long-term survival of approximately 20% and a median survival of 13 to 20 months. At the other end of the clinical spectrum, a high percentage (40% to 45%) of patients present with unresectable metastatic disease, with a short survival of only 3 to 6 months.
Mutations of the KRAS gene occurs in over 90% of pancreatic carcinomas – no other human tumor comes close in mutational frequency of this particular gene.
SOURCE
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