SAN FRANCISCO—Guardant Health has launched a new liquid biopsy test for researchers aimed at spotting cancer in its early stages, by detecting both genomic alterations and epigenomic signatures through a single blood draw.
The company’s Lunar assay is designed for studies that involve screening for tumor DNA in the bloodstream, choosing a course of adjuvant therapy, or monitoring potential recurrence and treatment responses.
“A number of our academic and biopharma partners are thinking more and more about taking their clinical programs into adjuvant and neoadjuvant settings,” Guardant’s senior VP of biopharma business development, Daniel Simon, said at the J.P. Morgan Healthcare Conference. “This is a really interesting application within that space.”
The Lunar assay is based on samples gathered from more than 80,000 cancer patients tested with the company’s Guardant360 test, alongside additional whole-genome sequencing data.
It aims to overcome previous challenges seen in detecting early-stage disease—such as biological noise mutations associated with aging, as well as the limited sensitivity of genomic-only tests—in settings where there is less tumor DNA to be found, compared to the late-stage cancer indications covered by the Guardant360 or GuardantOMNI tests, Simon said.
Detecting epigenetic markers, such as differences in the methylation of DNA from tumor cells compared to that from healthy cells, is critical in increasing the sensitivity of the test, the company said. For example, researchers at the University of Queensland in Australia recently found that the dense clusters of methyl groups lining tumor DNA can cause the molecules to fold into shapes that are easily detectable by the naked eye through a simple test.
“This is where the database of samples that we've already amassed becomes incredibly valuable,” he said. “We can continually learn from the 80,000 samples that we've run to date. We've also used lessons from those samples to improve the sensitivity of Guardant360 and developed Omni to have a comparable performance.”
According to Guardant, the assay improves upon Guardant360’s performance by reporting genomic alterations at allele frequencies as low as 0.01%. The company plans to launch a clinical version of the test, for investigational use only in prospective studies, in the second half of this year.
In addition, Guardant plans to submit its Guardant360 test to the FDA for premarket approval in the first half of this year, as a companion diagnostic for AstraZeneca’s EGFR inhibitor Tagrisso that is being developed under a multi-year agreement announced last month. It also plans to submit its GuardantOMNI panel for tumor mutational burden score by the end of 2019.