A multi-centre study comparing a new cartridge-based laboratory testing device called the Idylla automated system (Biocartis) to current standard-of-care testing methods, has reported that average turnaround time for test results could be cut by more than 65% from 15 days to five days, with some results available in a single day. The significant decrease in wait time means patients can begin appropriate treatments for colorectal cancer much sooner and the simplicity and ease of use of the new technology, compared with other molecular techniques, also makes it suitable for integration into clinical laboratories of any size, including those that may not have much molecular expertise.
The paper, ‘Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer’, was published in the American Journal of Clinical Pathology.
“This is the first such study to address turnaround time for when the oncologist receives clinically actionable results from the lab," said lead author, Dr Gregory J Tsongalis, of Dartmouth's and Dartmouth-Hitchcock's Norris Cotton Cancer Center. "Getting results to our oncologists in a timely fashion allows them to be better prepared in the selection of a therapeutic management strategy.”
In total, 20 laboratories enrolled 874 colorectal cancer cases between November 2017 and December 2018. Testing was performed on the Idylla system using the KRAS and NRAS-BRAF cartridges (research use only) and the results were compared with in-house standard-of-care testing methods.
There were sufficient data on 780 cases to measure turnaround time vs with standard assays. In-house polymerase chain reaction (PCR) had an average testing turnaround time of 5.6 days, send-out PCR of 22.5 days, in-house Sanger sequencing of 14.7 days, send-out Sanger of 17.8 days, in-house next-generation sequencing (NGS) of 12.5 days and send-out NGS of 20.0 days. Standard testing had an average turnaround time of 11 days. Idylla average time to results was 4.9 days with a range of 0.4 to 13.5 days.
The laboratories were all different types and sizes throughout the US and Puerto Rico, with an accrual of almost 800 colorectal cancer tissue samples to measure. In collecting the data, the study also addressed the use of minimal tissue from the patient sample.
“One of the study sites included several 1mm tissue biopsy samples, showing that even smaller tissue-based specimens can be successfully analysed by Idylla,” added Tsongalis. “Our results are in line with findings of other studies showing successful analyses using very small tissue amounts, including those deemed too small for standard molecular testing methods.”
Next steps include looking at strategies to integrate the new platform into regular laboratory processes.
“We already use something similar for our melanoma patients," concluded Tsongalis.
As the majority of care of cancer patients in the United States is provided in smaller medical facilities, this user-friendly system would allow those institutions to offer the most clinically actionable testing at their own hospitals with minimal hands-on time for testing and rapid result reporting.