Nicholas Dupuis (Presenter)
Biodesix Inc
Authorship: Nicholas F. Dupuis, Krista Meyer, Senait Asmellash, Kevin Sayers, Maximillian Steers, Don Ferraro, Heinrich Roder and Gary A. Pestano
Biodesix, Inc., 2970 Wilderness Place, Suite 100, Boulder, CO 80301
| Short Abstract BDX003 is a serum protein test combining MALDI-TOF with an AFP ELISA which classifies patients into two groups (HCC or NoHCC). The test was initially developed with two sample sets totaling 158 from HCC patients at various stages, and 135 patients with liver disease but no HCC. This development effort resulted in a test which detects HCC with 80% sensitivity and 79% specificity in the validation cohort. Here we present ongoing work to further characterize the BDX003 assay. HCC detection sensitivity will be tested in at least one independent sample cohort with a focus on early stage (I/II) cancer. We will also present results from pilot studies to evaluate reproducibility, stability, and cross platform portability of the test. |
Long Abstract
More than 600,000 people in the United States each year are at high risk of developing Hepatocellular Carcinoma.(1) These patients typically have co-morbidities including alcoholic cirrhosis (AC), chronic viral hepatitis (HBV/HCV), and nonalcoholic steatohepatitis (NASH) or nonalcoholic fatty liver disease (NAFLD). Currently, the high risk group is monitored with ultrasound (US) which is sometimes combined with monitoring of alpha fetoprotein levels. However, less than 30% of HCC is detected early enough to be treated through resection with curative intent and once the disease has progressed to multiple nodes or becomes large enough to prohibit resection the treatment options are few and the outcomes are poor. To address this unmet medical need we are continuing development on a serum based MALDI-TOF assay which has been shown to be able to detect HCC in high risk patients.
BDX003 is a serum protein test combining MALDI-TOF with an AFP ELISA which classifies patients into two groups (HCC or NoHCC).(2) The test was initially developed with two sample sets totaling 158 from HCC patients at various stages, and 135 patients with liver disease but no HCC. The sample sets were combined then divided into development and validation sub-sets while maintaining a balance between TNM status, lesion size, MELD score, cause of liver disease, and AFP levels. An algorithm was trained on the development data using the Diagnostic CortexTM classifier development platform.(2) This effort resulted in a test which detects HCC with 80% sensitivity and 79% specificity in the validation cohort.
Here we present ongoing work to further characterize the BDX003 assay. HCC detection sensitivity will be tested in at least one independent sample cohort with a focus on early stage (I/II) cancer. We will also present results from pilot studies to evaluate reproducibility, stability, and cross platform portability of the test.
References & Acknowledgements:
1. Scaglione S., et. al., The Epidemiology of Cirrhosis in the United States: A Population-based Study. J Clin. Gastroenterol. 2015 Sep; 49(8): 690-6
2. Mahalingam D., et al., A mass spectrometry based serum test for the detection of hepatocellular carcinoma (HCC) in high risk patients. The Liver Meeting 2015, November 14-17, 2015, San Francisco, CA.
| Description | Y/N | Source |
| Grants | no | |
| Salary | yes | Biodesix |
| Board Member | no | |
| Stock | no | |
| Expenses | no |
IP Royalty: no
| Planning to mention or discuss specific products or technology of the company(ies) listed above: | yes |