The study was led by Dr. Paul Hofman, head of the laboratory of clinical and experimental pathology at Pasteur Hospital in Nice, France.
The main purpose of the study was to assess if next-generation sequencing (NGS) testing for tumor mutation burden (TMB) assessment performed in-house was valuable in clinical decision making for immunotherapy, Hofman told us.
The assessment helps identify patients who might benefit from immune checkpoint inhibitor therapy.
Using the Oncomine Tumor Mutation Load Assay developed by Thermo Fisher, the researchers compared the predictive value of TMB assessed in-house to TMB assessed in a referral center after outsourcing the samples. The researchers found similar predictive values with the two panels, he explained.
“The implication in using in-house assessment is that the turnaround time for getting the results is shorter so all patients can receive an appropriate treatment,” Hofman said.
Per the study results, the researchers were able to secure results in as little as seven days, compared to 20 days or more when the test is outsourced – thus accelerating patient placement into applicable clinical trials.
For this reason and others, Hofman said more laboratories are interested in developing NGS in-house, to “master” turnaround time and raw data, as well to keep the DNA in-house.
“Outsourced testing has constraints,” Hofman said, “the cost is currently higher and the shipment must be well controlled, in particular on Friday depending on which country you are working in.”
Hofman noted that the referral center for TMB assessment used an FDA-approved test, while commercially available in-house testing panels are certified for research use only and are not appropriate for clinical routine practice.
“In-house NGS testing TMB assessment, in particular, has to be done in a laboratory having an accreditation for doing NGS,” he explained. “The laboratory must participate to external evaluation control (CLIA, for example), including different laboratories.”