NEW YORK (GenomeWeb) – OncoCyte shared data this week from the latest validation and optimization of its blood-based lung cancer test, showing that the test meets the expected sensitivity and specificity thresholds for the firm to launch commercially this year as planned.
OncoCyte's test is designed as a as a confirmatory tool — used after a lung nodule is discovered via radiologic imaging to help pick out patients who can avoid further interventions like a tissue biopsy.
Last year, company researchers and collaborators at the Wistar Institute who initially developed the assay reported 90 percent sensitivity and 62 percent specificity in distinguishing patients with benign nodules from those who turned out to have malignant cancers.
OncoCyte exceeded those metrics in the new data presented this week by University of Pennsylvania professor Anil Vachani at the American Thoracic Society 2017 International Conference. According to the presentation, the company's optimized predictive algorithm demonstrated 95 percent sensitivity and 73 percent specificity in 299 samples collected prospectively from 29 US sites.
For the newer results, OncoCyte refined its gene-expression algorithm to 15 of the most predictive markers from an original panel of 18 genes. The new approach also integrates clinical information on the size of detected nodules, authors reported.
OncoCyte President and CEO William Annett said in an interview that the accuracy the company has been able to achieve and demonstrate will hopefully put it in a position to claim a significant portion of what it believes could be up to a 1.4-million-patient, $4 billion annual market for this type of testing.
The test will face some existing competitors, although none using the same gene-expression approach.
Seattle-based Integrated Diagnostics, for example, launched its proteomic Xpresys Lung test in 2013, and has been working on a second, refined version for which it received a draft local coverage decision from Medicare contractor Palmetto GBA this January.
Cancer detection firm Oncimmune also offers an autoantibody-based test intended to assess patient risk both before CT scans, and in cases where CT identifies a suspicious lung nodule.
For its part, Integrated Diagnostics has thus far struggled to ramp up sales, with some physicians questioning whether the test's low positive predictive value might actually contribute to higher rates of unnecessary procedures.
OncoCyte's 73 percent specificity, while not perfect, is significantly higher than what Indi reported, at least for the first generation of its test, in previous publications.
UPenn's Vachani — who also participated in the validation of Indi's Xpresys Lung test — said in a statement that the new results he presented this week on OncoCyte's test suggest that it could represent a "fundamental advancement in the more accurate diagnosis of suspicious lung nodules."
According to Annett, OncoCyte is now turning its attention to building a commercial workforce and infrastructure, and preparing to address the challenges of convincing physicians to adopt the test and payors to reimburse it.
The firm is planning one final validation study to be performed in its CLIA lab once it receives certification from the state of California, in order to make sure the results match what it has seen in the R&D environment.
There are about 50 collaborating sites that are now contributing samples for this final study, and these all have the potential to become customers of OncoCyte's commercialized test, Annett added. However, the company is also gearing up to make its case to a broader base of lung specialists.
While other cancer screening tests like Exact Sciences' Cologuard might require marketing to a very wide spectrum of primary care physicians — or even education and advertising directed at patients themselves — lung nodules are primarily identified by specialists, which include mainly pumonologists but also radiologists. Lesions pop up either incidentally in the context of routine x-rays or as part of low-dose CT screening programs for individuals with an elevated cancer risk.
With that focus on specialist practices, Annett said that OncoCyte believes the best strategy will be to operate its own sales force, rather than contracting with an outside firm.
The company is now actively recruiting a head of sales, he said. And in the wings, it is also building up infrastructure for things like billing, data management, and test reporting.
With its assay still pre-launch, OncoCyte is also being proactive about laying the groundwork for reimbursement of the test by public and private payors.
Annett said that the company has already vetted its reimbursement strategy with payors, seeking feedback on its evidence plan and clinical utility study designs from about 10 companies that represent approximately 77 million covered lives.
Since lung nodules are detected largely in older individuals, Annett estimated that about half of OncoCyte's potential patients would be covered by Medicare, so the firm is also preparing to go through Palmetto's MolDx program.
With the launch of the lung cancer test later this year, OncoCyte will transition from a 100 percent focus on development to splitting its attention between R&D and the advancement of its first commercial product.
Annett said that validation of its next test, a protein-based assay with a similar confirmatory function in breast cancer, is progressing apace, with an expected launch in the latter half of 2018.