Fierce Biotech – OncoCyte, which is developing blood-based tests to catch cancer early, announced Monday that its lung cancer diagnostic succeeded in a 300-patient study. The company plans to launch the test in the second half of this year.
The company tested its algorithm on about 300 samples gathered from patients at 26 U.S. sites. The samples were taken from patients who had varying sizes of lung nodules. Nodule size plays a role in a physician’s decision whether to perform a tumor biopsy.
“Our goal is to have the first commercial blood test that can help physicians to better manage patients presenting with lung nodules, and to avoid a significant number of risky and costly biopsies,” said CEO Bill Annett in a statement.
OncoCyte is keeping mum on the study details until the data are unveiled at the American Thoracic Society (ATS) conference in May. But it did say that OncoCyte’s algorithm confirmed the results of a previous study conducted by the Wistar Institute presented at the CHEST annual meeting last fall. In that study, the liquid biopsy detected malignancies correctly in patients 90% of the time and benign lung nodules 62% of the time, according to a statement.
Wistar and OncoCyte go back a few years—they’ve been working on the lung cancer diagnostic since 2013, and the company sponsored Wistar’s recent study, as well as an earlier study that showed the proof of concept. In January last year, the pair inked a deal giving OncoCyte the exclusive rights to commercialize this test.
OncoCyte’s new study sought to replicate Wistar’s findings using its own equipment, Annett said. Next, OncoCyte will apply for CLIA-certification and embark on clinical validation studies, the last stop before commercialization, the company said.
The validation studies include internal studies as well as CLIA lab validation studies, both small and large, to show that using the system in the CLIA lab turns up the same results as it did in the R&D lab, Annett said. OncoCyte also plans to “ramp up” its sales and marketing teams in anticipation of the launch.
OncoCyte believes it could be the first company to bring an accurate, noninvasive, confirmatory blood test for lung cancer. Other players, including Guardant, Genomic Health and Roche, offer liquid biopsy, too, but these are used to help physicians make treatment decisions, and not to confirm a cancer diagnosis. Meanwhile, Grail has been raking it in—the Illumina spinoff recently raised $900 million in the first close of its Series B to support the development and validation of its cancer-detecting blood tests.
Source – Fierce Biotech