By Kirell Lakhman
New York regulators have cleared Oncimmune's EarlyCDT-Lung assay to be offered in the state, making the early lung cancer-detection and risk-assessment test available nationwide.
Although the De Soto, Kan.-based company has been offering the test to the other 49 states, the New York win is a significant milestone because the state's clinical lab permit-application processes is considered the most rigorous nationwide.
Oncimmune actually won New York's approval Aug. 31 but disclosed the decision today.
Debuting in the US in 2009 — three years after the company was founded — the blood-based EarlyCDT-Lung assay is designed to evaluate high-risk patients for the presence of specific autoantibodies associated with lung cancer.
The test uses a panel of tumor antigens to detect the autoantibodies, which are elevated in patients with the disease. Because these autoantibodies appear in the earliest stages of lung cancer, EarlyCDT-Lung is meant to help oncologists determine whether an asymptomatic patient indeed has the disease.
And because it is designed to be performed early in the cancer's development, the test could free patients, at least initially, from undergoing risky CT scans or uncomfortable and risky bronchoscopies.
Oncimmune's only product, EarlyCDT-Lung is performed exclusively at the company's CLIA lab in the metro Kansas City area.
The firm said it is developing an EarlyCDT-based test for early breast cancer detection. Breast and lung cancers are the No. 2 and 3 most-common forms of the disease, respectively, according to NCI.
In a statement, Oncimmune said its "mission" is to develop early cancer-detection tests that can identify more than 90 percent of solid-tumors — including lung, breast, colorectal, prostate, stomach, pancreatic and ovarian — which it said collectively comprise as much as 70 percent of all cancers.
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