BOULDER, Colo.--(BUSINESS WIRE)--Biodesix, Inc. today announced 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. 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.
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.
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 disease, 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, which will be commercially available in the second half of 2019, 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.
Beating cancer, one test at a time
Oncimmune is a leader in the development, manufacture and commercialisation of cancer specific immunodiagnostics for the screening, detection and care of cancer. Oncimmune also develops precision medicine and patient stratification tools for leading pharmaceutical multinationals in both autoimmune disease and immuno-oncology. Oncimmune is working to change how cancer is diagnosed and treated. Its patented technology detects evidence of the body's natural response to cancer, enabling detection four years or more before standard clinical diagnosis. Oncimmune’s tests facilitate clinical decision-making and are complementary to diagnostic technologies, making them valuable additions to established and new care pathways. Oncimmune partners with leading developers and distributors to make our technology available globally.
Oncimmune was founded in 2002 and launched its platform technology in 2009, followed by its first commercial tests, EarlyCDT Lung and EarlyCDT® Liver. To date, over 155,000 tests have been performed for patients worldwide. EarlyCDT Lung was also used in what is believed to be the largest randomized controlled study for the early detection of lung cancer using biomarkers, the National Health Service (NHS) ECLS study of 12,210 high-risk smokers in Scotland. 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.
Oncimmune, headquartered at its laboratory facility in Nottingham, UK, has a discovery research center in Dortmund, Germany and a CLIA lab in Kansas, US as well as offices in London, UK and a representative office in Shanghai, China. Oncimmune joined the Alternative Investment Market (AIM) of the London Stock Exchange in May 2016 under the ticker ONC.L.