PAPERS AT ASCO

On Sunday at ASCO, Oncimmune will share results from the most recent research on the test. Two presentations indicate its reliability, with one presentation suggesting the test works across ethnicities and with different demographics, and another that multiple samples from the same person match up with each other.


The company is also releasing the latest data on the test's accuracy. In this study, the researchers examined 500 cancer patients using the Early CDT Lung test.

The results resemble those found in a technical paper published February in the Annals of Oncology, which looked at collections of 12,000 patient samples with over 80,000 assays, Hamilton-Fairley said.

For lung cancer, the test has around 40 percent sensitivity and 90 percent specificity, with an overall accuracy of 88 percent, he said, which he thinks surpasses that of lung CT scans.

The test, designed for solid tumors, picks up all stages of the disease about equally, Hamilton-Fairley said. And a study conducted by the Mayo Clinic found it could find lung cancer about half a decade before a CT scan would pick up a nodule.

But Hamilton-Fairley believes that the most accurate results might come from using CT scans and the blood together. If a CT scan uncovers a nodule, the patient would then undergo an Early CDT test.

"If a nodule is picked up by a CT scan and there's a positive test, the risk of cancer increases three and a half times," Hamilton-Fairley said. "It's a very useful risk stratification tool."

While the lung cancer test is the first out of the gate, a breast cancer test could be available by the middle of next year.

"Our scientific advisory board believed [lung cancer] had the biggest need. It's the biggest cancer killer by miles, and there's nothing else," Hamilton-Fairley said.

Lung cancer takes a huge human and financial toll. It's the leading cause of cancer-related deaths in the United States, killing nearly 160,000 people in 2009, according to the National Cancer Institute. And the price of treating lung cancer victims in the United States amounts to around $10 billion a year.

That's partly why Oncimmune hopes to make the economic case for the test, which costs $475. In a separate presentation at ASCO, Oncimmune discusses a model which suggests using the test with CT scans is cost-effective.

Currently, the test is reimbursed by some health plans in the U.S. and Medicare Part B, although it's not reimbursed by the National Health Service in the United Kingdom yet, Hamilton-Fairley said.

As the technological requirements are fairly low, the test could also be useful in middle and low income countries, according to Oncimmune, where about half of all cancers will be diagnosed in the coming decades.

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