By Diagnostics World Staff
June 22, 2016 | Kailos Genetics and the Huntsman Cancer Institute (HCI) at the University of Utah have won a $2.4 million grant from the National Institutes of Health to develop a clinical-grade test for circulating tumor DNA (ctDNA) to monitor patients for breast cancer disease recurrence.
Kailos already offers breast and ovarian cancer screening tests, and with the Hudson Alpha Institute is about halfway through a breast cancer community sequencing project.
“We’ve all had our interest peaked by the ability to take a blood sample and identify genetic changes,” Troy Moore, chief scientific officer of Kailos, told Diagnostics World. “But when you’re looking at single base changes, your sensitivity has to be just incredible to get one change amongst a very small background of DNA that’s from the tumors.”
Katherine Varley, now an investigator at Huntsman Cancer Institute and assistant professor in the Department of Oncological Sciences at the University of Utah, has identified a set of methylation changes that essentially amplify the signal that one would see in recurrent breast cancer.
“With methylation, you have the ability to look at quite a few different changes that are all acting in unison to give you an overall pattern. It amplifies the signal, if you will,” Moore explains.
Varley was one of the scientific founders of Kailos while she was a post-doctoral fellow at the HudsonAlpha institute. When she joined the faculty of the Huntsman Cancer Institute in 2013, she continued to work with Kailos. The new NIH grant funds a five-year formal collaboration between Kailos and the Huntsman Cancer Institute.
The NIH grant will fund development of pre-clinical data looking at both single-base changes and methylation changes as tumors evolve, Moore explained. Samples will be collected from breast cancer patients before and after surgery from the Huntsman Cancer Institute in Utah and the Clearview Cancer Institute in Alabama. These patients will be followed throughout their recovery.
“We look at this as an opening of the doors to a whole new set of assays that I think will be very impactful in the clinic in the coming years,” Moore said. “I also think it’s going to be one of those areas that’s going to have to be very well studied and very well reviewed… These aren’t going to be things that are rapidly developed and put out to the market. We’re excited to be doing clinical work for this.”