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OncoCyte Applies for CLIA Lab Certification

NEW YORK (GenomeWeb) – OncoCyte said today that it has applied for CLIA lab certification, moving it closer to the objective of launching a lung cancer diagnostic test — its first commercial product — in the second half of 2017.

OncoCyte is developing diagnostic tests that use proprietary sets of genetic and protein markers that are differentially expressed in specific types of cancer. The tests, based on liquid biopsies using blood or urine samples, are intended for use as confirmatory diagnostic tests to detect lung, breast, and bladder cancer.

Earlier in March, the firm reported successful results for its lung cancer diagnostic test, and said that its algorithm confirmed the results of an earlier study by the Wistar Institute of Anatomy and Biology. That study pegged the lung cancer diagnostic test's sensitivity at 90 percent and specificity at 62 percent. OncoCyte said that it believes the results exceed levels that are needed for a commercially successful test.

OncoCyte CEO William Annett said in a statement that upon receipt of CLIA certification, the firm plans to conduct a small CLIA lab validation study to demonstrate that the assay system it employs provides the same results on clinical samples in the CLIA lab as in the R&D lab.

"Once this lab validation study is completed, we will initiate a clinical validation study of 300 blinded, prospectively collected samples," Annett said. "If the results replicate the positive results of our prior study, we will move to commercialization." 

Annett also noted that the total addressable market for the lung cancer diagnostic test could be more than $4 billion, depending on its efficacy and reimbursable pricing, and based on the firm's estimate of the number of patients who could be test candidates. He added that use of the test will reduce healthcare costs, because it eliminates unneeded biopsy procedures and associated complications.

OncoCyte said that it expects to receive CLIA certification during the second quarter of 2017.