BOULDER, Colo.—Biodesix, Inc. has announced its intent to extend the company’s blood-based lung cancer diagnostic portfolio with acquisition of Oncimmune Holdings Group’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States. 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.
“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.
“This agreement is a significant milestone for Oncimmune,” added Adam M. Hill, M.D., Ph.D., CEO of Oncimmune. “Like us, Biodesix is committed to developing and delivering lung cancer diagnostic solutions to improve patient outcomes. Early CDT 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.”
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 could lead to a future screening indication for the EarlyCDT Lung test.
“The addition of EarlyCDT Lung to the Biodesix portfolio will allow more patients to benefit from this unique diagnostic tool,” stated Scott Hutton, COO of Biodesix, in a press release. “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.”
Oncimmune reported that the study met its primary endpoint showing that the use of EarlyCDT—Lung with subsequent X-ray and computerized tomography (CT) scan reduced the incidence of patients with late-stage lung cancer or unclassified presentation at diagnosis, compared to standard clinical practice.
“The final results from the ECLS study, which I believe is the largest study of its type ever undertaken for early lung cancer detection, represents the culmination of over 16 years of research and development by Oncimmune’s scientists and our collaborators,” noted Hill. “I am particularly excited about the potential now for scalable impact using EarlyCDT—Lung in a cancer control evaluation in Scotland, expected to commence later this year as well as the ripple effect of this landmark study on lung screening programs further afield.”
A submission of the full ECLS study findings is being prepared for a leading peer-reviewed medical publication, and is expected to be published in the third quarter of 2019.
Oncimmune also reported that preparations are underway in Scotland for the conduct of a phased population-based evaluation to assess the implications of diagnosis with EarlyCDT—Lung on survival and mortality in a real-world setting. The initial phase is expected to recruit up to 200,000 patients, each to be tested with EarlyCDT—Lung to be supplied by Oncimmune on negotiated commercial terms.
Under the terms of the agreement, 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.