Roche Foundation Medicine is pleased to announce the launch of FoundationOne®Liquid, our new second-generation liquid biopsy test for patients with solid tumours.56
Granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) in April 2018, FoundationOne®Liquid builds on the technology of FoundationACT® and now includes more than 70 genes and genomic biomarkers for microsatellite instability (MSI).56
Maintaining its clinically practical single blood draw of two tubes of blood sampling method, FoundationOne®Liquid aims to be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.56,57
The planned launch of FoundationOne®Liquid globally is this year and will be available to order for your patients soon so kindly watch this space.
DOES THE FOUNDATIONONE®LIQUID CTDNA ASSAY APPLY TO ALL TYPES OF CANCER?
WHO IS ELIGIBLE FOR A FOUNDATIONONE®LIQUID PROFILE?
FoundationOne® is our flagship profile for patients with solid
tumours. However, in cases where Comprehensive Genomic Profiling (CGP) with FoundationOne® is not possible or feasible, the patient may be eligible for profiling with FoundationOne®Liquid.
WHEN MAY FOUNDATIONONE®LIQUID BE USED IN PLACE OF FOUNDATIONONE®?
FoundationOne®Liquid is an alternative profiling method to FoundationOne® in cases where there is insufficient or inadequate tissue from a recent biopsy,23 or where repeat analyses have led to tissue exhaustion precluding subsequent testing.33
In other instances, procedural limitations can be the prohibiting factor, such as when
directbiopsy is technically difficult to obtain,23 or when progression or recurrence is suspected and a repeat biopsy is not feasible.33
WHAT IS CIRCULATING TUMOUR DNA (ctDNA) AND WHY IS IT USEFUL?
Sometimes patient factors can determine the need for profiling with FoundationOne®Liquid, for example, if tissue biopsy poses an unacceptable risk to the patient,22,23 or the patient refuses a tissue biopsy.
IS CTDNA DIFFICULT TO DETECT?
Detecting ctDNA can be challenging.23, 36 Circulating cell‑free DNA (cfDNA) is highly fragmented, present at very low concentrations, and contains only a small fraction of
tumour‑derivedctDNA (often <1.0% of total cfDNA).22,33,35,36 Not all tumoursshed DNA into bloodstream, so ctDNA may not be detected in all patients. The level of ctDNA is also known to vary considerably (between 0.01% to 90%),33,37 depending on tumourtype, tumourstage, and a range of other factors, including rateof release, physiological factors (e.g. renal function) and time of blood draw.22,33,37‑42
As a result, the isolation and identification of ctDNA require ultrasensitive analytical analysis.22,36