How accurate is Guardant 360?

How accurate is Guardant 360?

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.

What is Guardant health?

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.

What cancers are detected by blood tests?

What types of blood tests can help detect cancer?

  • Prostate-specific antigen (PSA) for prostate cancer.
  • Cancer antigen-125 (CA-125) for ovarian cancer.
  • Calcitonin for medullary thyroid cancer.
  • Alpha-fetoprotein (AFP) for liver cancer and testicular cancer.

Is Guardant360 covered by insurance?

The policy covers Guardant360 for all fee-for-service Medicare patients with advanced cancers who meet its clinical criteria for complete genomic profiling with next-generation sequencing (NGS) of tumor tissue to optimize treatment selection decisions but have insufficient or unavailable tissue for molecular profiling.

Is Guardant health a good company?

Is Guardant Health a good company to work for? Guardant Health has an overall rating of 3.6 out of 5, based on over 131 reviews left anonymously by employees. Employees also rated Guardant Health 3.5 out of 5 for work life balance, 3.8 for culture and values and 4 for career opportunities.

What cancers are not detected by blood tests?

During the trial, 24 additional cancers not identified by the blood test were picked up by standard screening: 20 breast cancers, 3 lung cancers, and 1 colorectal cancer. Of the 24 cancers, 22 were early-stage cancers.

Would a full blood count show anything serious?

Instead, if your full blood count indicates that a certain blood cell is abnormally high or low, this may indicate infection, anaemia, or other more serious diseases. Depending on the results, the GP may then request more tests to confirm a diagnosis.

Is Guardant 360 FDA approved?

The FDA has approved Guardant360, a liquid biopsy companion diagnostic for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer who have a KRAS G12C mutation and may benefit from sotorasib.

How is guardant360 CDX performed?

Guardant360 CDx is performed by a single laboratory, the Guardant Health Clinical Laboratory, located in Redwood City, CA, USA. Guardant360 CDx is composed of the following major processes: a. Whole Blood Collection and Shipping b. Plasma Isolation and cfDNA Extraction c. Library Preparation and Enrichment d. DNA Sequencing e.

What is the purpose of the guardant360 test?

Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm. The test is for use with patients 2 of 102 5/2021 D-001590 R1 Guardant360 CDx Technical Information

Does the guardant360 CDX+ tissue–subjects contribute to efficacy?

Sensitivity analysis modeling efficacy in the entire Guardant360 CDx+intended use population demonstrates robustness to the contribution of the unrepresented Guardant360 CDx+ tissue–subjects, with estimated ORRs highly similar to the observed (Table 54vs. Table 53, respectively) due to the high NPA of Guardant360 CDx relative to the

How long does it take to get guardant360 results?

Draw blood first. Make plans fast. Get guideline-complete genomic results in only 7 days with a simple blood draw. Seamlessly integrate Guardant360 CDx into your practice. Comprehensive support and educational resources for you and your patients.

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