Lung Cancer
Credit: Lee Health

The stress associated with “watching and waiting” and wondering if a tumor is cancerous or not may soon be a thing of the past for those at risk for lung cancer.  Biotechnology company Biodesix, Inc. is extending its portfolio of blood-based assay tests by releasing Nodify CDT™, an assay designed to assist physicians in identifying tumors at high risk for turning cancerous in the lung.  This test works by means of a liquid biopsy on a simple blood draw, to determine if incidental lung nodules found in at-risk patients are malignant.

Nodify CDT testing works by utilizing the patient’s own immune system, which is capable of detecting disease on its own. The test detects circulating antibody proteins released in the presence of lung cancer and generated by the patient’s immune system. The test results themselves will generally take one day to generate, after the patient’s blood arrives at Biodesix’s lab in De Soto, KS.

Nodify CDT is designed to complement another of Biodesix’s clinical assays, Nodify XL2™, an earlier release from the company that is also a liquid biopsy for a simple blood draw.  Nodify XL2 is designed to help identify lung nodules with a very low risk of cancer. Both tests will be offered together under the ‘Nodify Lung Nodule Risk Assessment’ strategy, allowing physicians the ability to order both tests from a single blood draw.

Having one test determine if a patient is low risk and another test determine if a patient is high risk can serve as an internal set of controls for physicians making a final decision on the nodule or nodules.

“Given the short turnaround time of these tests, we can help physicians move patients quickly from lung nodule discovery to a definitive care plan.” said Scott Hutton, Biodesix CEO.

“Between the Nodify CDT and Nodify XL2 tests, we have an opportunity to redefine risk assessment for patients with suspicious lung nodules. With a single blood draw, we can help physicians identify people who are either more or less likely to have lung cancer,” Hutton continued.

“We are grateful for Biodesix’s leadership in developing tests that help patients to know, without subjecting them to unnecessary procedures and losing precious time, what their risk level is for lung cancer,” commented Bonnie Addario, co-founder and board chair for the GO2 Foundation for Lung Cancer. “This reduces much of the uncertainty that plagues patients from the time a nodule is discovered until a care plan is determined.”

The GO2 Foundation for Lung Cancer is an organization founded by lung cancer patients and survivors and dedicated to saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer.

Lung cancer is one of the most common and deadliest cancer in the United States, and the lowest survival rates correspond with cancers that are caught at later stages, after the tumors have metastasized and are resistant to treatment.  The GO2 Foundation for Lung Cancer helps raise public awareness for the disease as well as funding for research in search of a cure.

Hutton said, “1.6 million Americans are diagnosed with incidental lung nodules each year; the problem physicians face is that it’s often difficult to determine whether a nodule is cancer or not without the patient undergoing an invasive procedure to get a tissue sample for further testing. These procedures are costly and carry a risk of complications even though many times the nodule is harmless. The alternative is to enter a watchful waiting period where a patient comes in every 3–6 months for follow-up scans to see if the nodule grows or changes in a way that indicates it may be cancer. This waiting can cause a stress for the patient and their families. Physicians need better tools to assess the risk of cancer and inform which path to take.”

Oftentimes this waiting period can cause a great deal of stress for the patient, as well as potentially lost time for aggressive cancers. This liquid biopsy testing platform allows nearly immediate determination of the nature of a tumor that might be impossible to tissue biopsy, and eases patient worry in that there is less unknown and more understanding of the type of disease they need treatment for.

Biodesix is a lung cancer diagnostic solutions company covering the continuum of patient care from early risk classification of lung nodules through treatment guidance in late stage cancer. This company has developed multiple blood-based diagnostic tests for clinical use that combine multi-omics with the power of artificial intelligence. Of particular interest to lung cancer patients, Biodesix is the first company to offer four approved, non-invasive tests for patients with lung cancer or suspicious lung nodules, including the Biodesix Lung Reflex® strategy for lung cancer patients that integrates GeneStrat® and VeriStrat® tests to support treatment decisions and provide results in 72 hours. These tests are further complementary to the Nodify XL2 test and the Nodify CDT assays.

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