OncoCyte blood test to rule out lung malignancies heads for commercial launch following study

test tubes
The results support OncoCyte’s plans to make DetermaVu commercially available in the second half of this year, in what the company describes as a $4.7 billion market opportunity. (Pixabay)

OncoCyte has delivered new positive results from a study of its DetermaVu blood test for lung cancer, which is designed to rule out patients who have a suspicious lung nodule but do not require an immediate biopsy.

The test showed 90% sensitivity in spotting malignant nodules in a prospective study and 75% specificity in identifying those that were benign out of a cohort of 250 patient samples. In addition, the test made its determinations without including any clinical factors in its algorithm, such as the size of the lung nodule, the company said.

The test measures gene expression biomarkers related to a patient’s immune system response to early-stage lung cancer. OncoCyte believes its approach could have applications in detecting other early-stage cancers as well and has plans to study its use in other indications.

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“Physicians need better tools to diagnose malignant versus benign lung nodules in order to reduce the large number of unnecessary lung biopsies that create risks for patients and are costly to the healthcare system,” said OncoCyte President and CEO William Annett in a release.

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The results support OncoCyte’s plans to make DetermaVu commercially available in the second half of this year, in what the company describes as a $4.7 billion market opportunity. OncoCyte’s stock rose at least 200% on the news, to $5.46.

With follow-up biopsies of newly discovered lung nodules fetching an average of $15,000 each, not including the costs of complications and recovery, OncoCyte believes the specificity of its test could eliminate up to three-quarters of unnecessary procedures—reducing U.S. healthcare costs by potentially billions of dollars by directing patients with benign nodules to longer-term monitoring.

Other companies in the “rule-out” lung cancer space include Biodesix, which acquired its XL2 proteomic classifier test from Integrated Diagnostics last year. That test is currently gathering patient data through a registry program ahead of a wider commercial launch planned for later this year.