On June 28, 2019 Biodesix, Inc. reported that it will extend the company’s blood-based lung cancer diagnostic portfolio with acquisition of Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States (Press release, Biodesix, JUN 28, 2019, View Source [SID1234537330]). The United Kingdom-based company’s U.S. operations, including a CLIA lab in De Soto, Kansas, will transition to Biodesix on November 1, 2019. The lab is the sole U.S. provider of Oncimmune’s EarlyCDT -Lung test.
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"Oncimmune’s extensive experience and patent portfolio in autoantibodies, and their relationship to cancer, attracted us to evaluate the use of Oncimmune’s EarlyCDT Lung test as a strategic addition to our diagnostic test offering in the U.S.," said David Brunel, CEO of Biodesix. "Biodesix is the leader in blood-based diagnostic solutions for lung cancer that provide actionable results and reimbursement with best-in-class turnaround time. Our Nodify XL2 test is used to help rule-out malignancy in low-to-moderate risk incidental lung nodules. EarlyCDT Lung is a rule-in test for lung cancer risk, and a natural and important extension of our commitment to care in the early disease setting."
Each year 1.6 million Americans are diagnosed with incidental lung nodules. Most of these nodules are benign, but the EarlyCDT Lung test helps identify those that could be cancerous. The blood-based lung nodule test enables earlier intervention by helping clinicians detect lung cancer at all stages of disease (I-IV). The extensively validated proteomic test measures seven autoantibodies to tumor-associated antigens created by the body’s response to cancer.
In addition to the lung nodule indication, the Early Cancer Detection Test – Lung Cancer Scotland (ECLS) study, a 12,210 patient study investigating the utility of the EarlyCDT Lung test in lung cancer screening, recently announced meeting primary end-points. ECLS is believed to be the largest randomized controlled study using biomarkers for detection of lung cancer and could lead to a future screening indication for the EarlyCDT Lung test. Full results from the study will be published in a peer-reviewed publication later this year.
"The addition of EarlyCDT Lung to the Biodesix portfolio will allow more patients to benefit from this unique diagnostic tool," said Scott Hutton, COO of Biodesix. "The Nodify XL2 and EarlyCDT Lung tests complement each other to help provide physicians with the ability to stratify patients into distinct nodule management pathways."
"This agreement is a significant milestone for Oncimmune," said Adam M. Hill, MD Ph.D, CEO of Oncimmune. "Like us, Biodesix is committed to developing and delivering lung cancer diagnostic solutions to improve patient outcomes. EarlyCDT Lung is highly complementary to Nodify XL2 to help guide treatment decisions, and Biodesix is an excellent partner for Oncimmune in the U.S. market."
Additional terms of the agreement provide that Biodesix will make milestone payments to Oncimmune upon achieving certain commercial objectives. In addition, Oncimmune will continue to collaborate with Biodesix on new strategic endeavors to improve patient outcomes in lung cancer.