Guardant Health CEO Helmy Eltoukhy said that his firm, formerly focused solely on blood-based cancer genotyping, plans to launch two new products this year, including a comprehensive tissue sequencing assay that would compete with tests from leaders in the space like Foundation Medicine, Caris Life Sciences, and others.
The company also intends to release a minimal residual disease test it has now dubbed GuardantReveal, formerly known as Lunar-1, by the end of the first quarter of 2021, although the long-term trials assessing the assays clinical impact are still ongoing.
Guardant said the Reveal assay has a seven-day turnaround time and is intended to detect residual disease and surveil for emerging recurrences in patients with earlier-stage cancer who have had surgery or other treatments with curative intent.
Currently the test is for use only in colorectal cancer patients, but the company is also working to validate it in additional tumor types. Unlike some other blood-based MRD tests, such as Natera's Signatera, which require upfront tissue sequencing to create patient specific liquid biopsy assays, GuardantReveal is universal and performed directly on blood without the need for tissue samples.
The firm's most recent data for the assay demonstrated 91 percent sensitivity and 100 percent specificity for recurrence detection.
Outside of these new product launches, the Redwood City, California-based firm also believes it will see growing adoption of its existing tumor genotyping tests, following the approval it received last year from the US Food and Drug Administration for the CDx version of its core assay, Guardant360.
The company believes that Guardant360 CDx — which is approved for genomic profiling of all solid tumors, and as a companion diagnostic to determine patient eligibility for the EGFR-targeting drug osimertinib (AstraZeneca's Tagrisso) — will be critical in accelerating adoption of liquid biopsy testing, especially among oncologists who have been on the sidelines with respect to comprehensive genomic profiling.
Guardant also launched an update to the LDT version of Guardant360 last year, adding both additional targets and what the firm believes to be a best-in-class blood-based calculation of tumor mutational burden.
Eltoukhy said that Guardant's 2020 Q1, Q2, and Q3 test volumes increased 60 percent, 15, percent, and 28 percent respectively year over year, growing to just under 17,000 tests in the third quarter last year, driven by further shifts in the cancer genotyping market to a blood-first paradigm, and expansion in the use of repeat testing.
But as much progress as the firm has made, it's CEO said that it's clear that Guardant is still very much in the early innings of adoption for the 700,000 patients that have metastatic disease of solid tumors, and there is "ample room" for it to further fill the lingering gap between clinical guidelines and clinical practice.
Areas outside of standard tumor profiling that the company continues to pursue for Guardant360 include the molecular assessment and tracking of therapy response.
Finally, Eltoukhy reiterated Guardant's confidence that it is on track to complete enrollment of the ongoing prospective study of its Lunar-2 colorectal cancer screening assay by the end of this year. If successful, this ECLIPSE trial is expected to play a pivotal role in a potential FDA submission.
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