OncoCyte Corp, which is developing diagnostics in the fledgling field of liquid biopsies, said on Monday a 300-patient validation study of its blood test for early detection of lung cancer has confirmed the accuracy reported from a prior trial.
OncoCyte said it was preparing for a commercial launch of the test as early as the second half of this year and expects it will be the first product of its kind for lung cancer to reach the market.
Liquid biopsies use blood or urine to determine the presence of cancer and can help spare patients from unnecessary invasive biopsies, that are risky, expensive and most often find tested tissue to be benign.
With a traditional lung biopsy, a needle is plunged into the lung to remove part of a nodule or suspect tissue for laboratory testing. It can cause serious complications requiring hospitalization, including collapsed lungs, infection and in some cases death.
OncoCyte said it would price its test at about 20 percent to 25 percent of the cost of a standard of care lung biopsy, which can run about $15,000.
The test is being developed at a time when people at high-risk for lung cancer, such as long-time heavy smokers, are being encouraged to get annual CT scans aimed at catching the deadly disease early, when favorable treatment outcomes are far more likely.
Currently, when CT scans reveal suspicious lung nodules larger than about 5 millimeters, the next step is a needle biopsy that could be avoided with a reliable non-invasive test showing the nodule to be benign.
OncoCyte said about 1.4 million U.S. patients a year are found to have lung nodules 5mm or larger, making for a sizable market for alternative diagnostics.
A previously-reported study of more than 600 patients found the OncoCyte test had a sensitivity of 90 percent and specificity of 62 percent. That means it accurately detected cancer 90 percent of the time, while demonstrating an ability to identify false positives 62 percent of the time. The latter is the key measure that could help spare many patients from unnecessary biopsies and health insurers from paying for avoidable procedures and potential complications.
OncoCyte said it believes the data provides a level of accuracy well above what is necessary for a commercially successful test.
"If the assay continues to perform at these levels, it could create a significant improvement in the standard of care in lung nodule management," Dr. Anil Vachani, the study's lead investigator, said in a statement.
Vachani, from the University of Pennsylvania, will present details of the latest findings at a medical meeting in late May, the company said.
OncoCyte said it was taking steps to have its testing laboratory certified by regulators, after which it must do one more 300-patient confirmatory study to demonstrate tests performed in that lab provide similar accuracy to those done at its research facility.
Chief Executive William Annett said he believes that can all be completed this year.