Case Study Based Review of Companion Diagnostic (CDx) Capabilities and Importance of Monitoring KRAS mutations
BOULDER, Colo.–(BUSINESS WIRE)–Biodesix, Inc. today provided updates on continued expansion of pipeline and companion diagnostic developments. Chief Development Officer Dr. Gary Pestano, Ph.D., highlighted the company’s capabilities in the development and commercialization of companion diagnostics aimed at directing the treatment of non-small cell lung cancer (NSCLC) at the 2019 Clinical Biomarkers & World CDx Conference. Director of Scientific & Medical Affairs, Dr. Yishan Chuang, Ph.D., presented real-world data on the importance of monitoring KRAS mutations in blood at the RAS-Targeted Drug Discovery meeting.
Companion Diagnostic Developments
Dr. Pestano cited two case studies of recent projects in CDx development. The first outlined Biodesix’s worldwide agreement to develop and commercialize the hepatocyte growth factor inhibitor antibody ficlatuzumab with Aveo Oncology (AVEO), using Biodesix’s proprietary VeriStrat® test as a CDx to identify NSCLC patients most likely to benefit from treatment with ficlatuzumab.
Biodesix’s recent agreement with Thermo Fisher was also presented, highlighting the ability to access a global footprint of instruments with rapid turn-around time and low-input material requirements for a liquid biopsy NGS test. The 52-gene panel is currently under dual track single-site PMA review by the FDA and CMS, with a goal of gaining approval with reimbursement in 2020. The approval will be initially focused on EGFR and NSCLC, with the ability to extend into other targets and indications as new partnerships develop.
“Our ongoing efforts in the discovery, development, and commercialization of companion diagnostic tests alongside our partners in biopharma further demonstrates Biodesix’s commitment to advancing precision medicine,” said Pestano. “Companion diagnostics, in addition to Biodesix’s portfolio of proprietary blood-based tests both currently available and in development, are designed to answer critical unmet needs across the continuum of care in oncology, NSCLC, and lung disease.”
Monitoring KRAS Mutations in Blood
Dr. Chuang shared data from INSIGHT, an observational study assessing real-world clinical utility of VeriStrat and GeneStrat® testing in 3,000 NSCLC patients across 33 sites in the U.S. Results from the INSIGHT study demonstrate poor response to treatment with platinum doublet-based chemotherapy in patients when KRAS mutations are detected in the blood (OS 3.4 months v. 14.0 months, p<0.001). It was noted that the particularly poor prognosis observed in these groups may be linked to tumors that shed DNA into the blood having a more aggressive disease state to those that don’t, highlighting the value of blood-based testing in addition to standard tissue testing. Additionally, longitudinal monitoring of KRAS mutation clearance in the blood may be an important indicator for treatment response. Dr. Chuang also noted that by combing information from both the circulating proteome with the VeriStrat test and circulating genome with GeneStrat testing provides additional value in predicting NSCLC patient prognosis.
“With the exciting development of KRAS targeted therapy in clinical studies, there is an increasing need for swift mutation testing with liquid biopsy,” said Dr. Chuang. “From Biodesix’s INSIGHT study, we also see that patient prognosis could be further elucidated when we consider both KRAS mutation information in combination with the circulating proteome in blood.”
About Biodesix
Biodesix is a lung cancer diagnostic solutions company addressing the continuum of patient care from early diagnosis of lung nodules through late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics with the power of artificial intelligence. Biodesix is the first company to offer three best-in class tests for patients with lung cancer, and multiple pipeline tests including one with the potential to identify patients who may benefit from immunotherapies. The Biodesix Lung Reflex® strategy integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours. The Nodify XL2™ nodule test, evaluates the risk of malignancy, enabling physicians to triage patients to the most appropriate course of action. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com.
Contacts
Kena Hudson for Biodesix
Kena@HudBio.com
(510) 908-0966