What is Guardant360®?
Guardant360® - An Overview
Liquid biopsy is especially an option for patients
- For whom no biopsy can be performed
- Whose tumor is unobtainable
- For whom no sufficient tumor tissue is available for an adequate biological evaluation of the tumor
- For whom archived biopsies or results are outdated
- For whom one or more interventions have occured since the last biopsy
How does Guardant360® work?
Efficacy test for targeted drugs
Monitoring and aftercare of a cancer therapy
Advantages and quality criteria of Guardant360®
- Guardant360® is the first clinically validated comprehensive liquid biopsy that is available and allows a comprehensive molecular analysis based on the evaluation of ctDNA.
- It is used by oncologists in leading cancer centers and more than 1000 hospitals worldwide. More than 40,000 patients have been sequenced.
- Numerous studies and publications verify the benefit of Guardant360® for therapy planning of cancer patients (http://guardanthealth.com/publications/). Compared to other liquid biopsies Guardant360® has more peer-reviewed publications, including clinical outcome studies.
- The laboratory of Guardant Health is CLIA-certified and CAP-accredited.
- Since a tumor is heterogenous and within a tumor there could be different types of cancer cells, it could be that when doing a normal biopsy only a specific type of cancer cells is taken out and not all present mutations of the tumor are detected. When these cancer cells afterwards are tested for the efficacy of drugs, a drug is found that is effective against these cancer cells. However it could be that there are other cancer cells in the tumor with additional mutations which do not respond to the therapy and continue to spread. With liquid biopsy all types of present mutations of the cancer cells are detected at the same time and thus the therapy can be adapted much better.
- In case of progression newly formed mutations can be detected.
- Contrary to tests where tumor tissue is needed, with Guardant360® a comprehensive non-invasive genotyping of cancer patients can be performed even when a normal biopsy is not possible or biopsy material is not sufficient.
- With Guardant360® (repeated) painful, expensive and risky biopsies are avoided since only 2 vials (10 ml) of blood are required. Therefore it can be perfomed frequently when required.
- The concentration of ctDNA within the blood is very low. Standard sequencing techniques are not specific and sensitive enough to detect mutations of the ctDNA correctly. The secured digital sequencing method of Guardant360® is 1000x more accurate than standard sequencing methods and results in a 99.9999% specificity. Nearly all false positive results are eliminated.
- Guardant360® identifies all measurable somatic genomic targets, which are recommended by the guidelines. 73 genes are sequenced and all 4 main types of alterations (point mutations, amplifications, fusions and indels) are detected. These genes encode for targetable proteins. Not only common hotspots but also whole exons are sequenced.
- In 85% of the cases mutations are found. These could lead to three different results regarding single targeted drugs in the report: 1) FDA approved indication for this tumor, 2) FDA approved indication for other tumors and 3) trials available.
- The results of the liquid biopsy suggest physicians and patients available treatment options (approved therapies and clinical trials), which are customized to the specific cancer of a single patient. This indicates that Guardant360® is used for the area of personalized medicine.
- Guardant360® can also be applied for the monitoring and aftercare of a cancer therapy.