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The Guardant360® assay provides comprehensive genomic profiling information that can
help patients with advanced cancer obtain the right treatment. The Guardant360® test is also useful to pharmaceutical companies as it is enabling the advancement of new therapies to market faster.

Our solutions for patients with cancer are enabled by Guardant Health’s proprietary Digital Sequencing technology. We combined robust, high-efficiency biochemistry at the front-end, with next-generation sequencing and a machine-learning augmented bioinformatics pipeline, to create a platform we believe delivers the clinical sensitivity levels necessary for best-in-class products today and tomorrow across all stages of cancer.

Treatment Selection: For patients with advanced cancer

Targeted cancer therapies provide better patient outcomes and fewer side effects than broad-based chemotherapy. But an individual’s response to a given treatment often depends on the tumor’s genomic profile.

Guardant360® provides comprehensive genomic results from a simple blood draw in approximately seven days upon receipt in the US laboratory, helping them move beyond the limitations of tissue biopsies to match patients with the best treatments. Obtaining clinically relevant genomic information through a blood draw helps them avoid an additional tissue biopsy and moves beyond the limitations of tissue specimens. Guardant360® detects all four classes of genomic variations in 74 genes most relevant to multiple solid tumors including microsatellite instability-high (MSI-high).

Since its launch in 2014, the Guardant360® assay has been ordered by more than 7,000 oncologists over 150,000 times for patients with advanced cancer to help select treatment.

If you are a healthcare provider looking for information about Guardant360®, please visit our product website.  If you are located in Asia, Middle East or Africa and would like to request a Guardant360® kit for your patient, click here.

Accelerating Clinical Trials

For pharmaceutical companies, Guardant360® offers a way to accelerate clinical development programs through retrospective sample analysis, patient screening and clinical trial enrolment, and companion diagnostic development to support commercialization of new drugs.

Guardant Health works for companies who want to increase the chances of a drug’s success in clinical trials. Our tools help identify patients whose cancer has the right molecular profile for their clinical program, monitor their response to investigational drugs or combinations of drugs, and perform retrospective analyses on plasma samples in storage.

Industrywide, nearly 70 percent of the oncology drug development pipeline in 2016 was for targeted therapies and immunotherapy agents. GuardantOMNI™, launched in 2017, is designed for biopharmaceutical customers to use as a comprehensive genomic profiling tool to help accelerate clinical development programs in immuno-oncology and targeted therapy. A 500-gene panel with breadth that is significantly larger than that of Guardant360®, with comparable performance incorporating the vast majority of all genes being evaluated in cancer drug development pipelines and biomarkers for immuno-oncology applications, including tumor mutational burden.

Companies who want to increase the chances of a drug’s success in clinical trials use GuardantOMNI™ to help identify patients whose cancer has the right molecular profile for their clinical program. GuardantOMNI™ also helps monitor patient response to investigational drugs or combinations of drugs, and perform retrospective analyses on plasma samples in storage.

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Ordering Process

Physician to request a kit online or contact our local partner

2 tubes of blood
(10ml each) to be drawn from patient and stored in Streck tubes provided

Kit to be stored at room temperature and couriered to the US laboratory

Test report to be emailed to physician in approximately 7 days upon sample receipt in the US laboratory

FAQs

A single blood draw of two tubes of blood (10ml each) from the patient is required.

Guardant360® is recommended for advanced stage cancer patients with solid tumors, at diagnosis and at disease progression.

Guardant360® is not indicated for:
– Early stage cancer
– When disease is stable or responding to therapy
– Blood cancer / hematologic malignancy

Before first-line therapy
By utilizing Guardant360® at diagnosis before first-line therapy, physicians can get ahead of the challenges of tissue testing in advanced solid-tumor cancers and use this information to guide treatment decisions.

At progression
Potential treatment options can be identified for advanced cancer patients progressing on treatment as the Guardant360® test detects all four classes of genomic variations in 74 genes most relevant to multiple solid tumors including microsatellite instability-high (MSI-high).

Cancer types where genetic abnormalities can be detected by Guardant360 (but not limited to): breast, colorectal, ovarian, non-small-cell lung carcinoma (NSCLC), pancreatic, prostrate, cholangiocarcinoma, gastric, gastroesophageal, melanoma, thyroid, cancer of unknown primary (CUP) and gastrointestinal stromal tumor (GIST).

Point mutation (single nucleotide variant, SNV)
Insertion or deletion (IN/DEL)
Amplification (copy number variation, CNV)
Gene rearrangement (fusion)
Microsatellite instability-high (MSI-high)

The turnaround time is approximately 7 days from the date the sample reaches the Guardant Health laboratory in the US.

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