Solutions

Our commercially available tests provide information that can help advanced cancer patients obtain the right treatment and pharmaceutical companies bring new therapies to market faster.

All our solutions for patients with cancer are supported by Guardant’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 AND RESPONSE MONITORING
FOR PATIENTS WITH ADVANCED CANCER

Precision medicine is becoming increasingly important for advanced cancer patients. Certain 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 genomic profile of their tumor.

For oncologists, the FDA-approved Guardant360® CDx provides comprehensive genomic results from a simple blood draw in seven days, 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 patients avoid an additional tissue or surgical biopsy and moves beyond the limitations of tissue specimens. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including the 55 genes most relevant to clinical care.

Guardant360 CDx is FDA approved for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), across all solid cancers and also as a companion diagnostic to identify non-small cell lung cancer patients who may benefit from treatment with Tagrisso® (osimertinib), RYBREVANT™ (amivantamab-vmjw), and LUMAKRAS™ (sotorasib).

Since being introduced, the Guardant360 laboratory developed test (LDT) has become widely accepted for blood-based CGP with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives. Note: Coverage information for patients.

If you are a healthcare provider in the United States or Europe looking for information about Guardant360 CDx, please visit our product website. If you are a healthcare provider in Asia, Middle East, or Africa, please visit this website.

In the event the test is not fully covered by insurance, patients may be eligible for financial assistance based on medical and financial need. To learn more, contact Guardant Health client services. For patients without insurance, the cash pay rate for Guardant360 CDx is $5,000 effective the first day of commercial launch September 28, 2020.

Disclaimer: Represented here is the Professional Services part of the report. The results for the biomarkers shown on this report are not prescriptive or conclusive for labeled use of any specific therapeutic product. For the Guardant360 CDx intended use statement, please refer to the Guardant360 CDx Report. For further information, see Technical Information.

Our Guardant360 laboratory developed test:

150,000+

Clinical Samples Reported

60+

Biopharma Partners

9,000+

Ordering Oncologists

200+

Peer-Reviewed Publications

For oncologists who want even more information to guide treatment beyond standard of care, the Guardant360 LDT offers the same technology as our approved test, with 80+ genes and full coverage of NTRK1-3 fusions, HRR-related genes, and blood tumor mutational burden (bTMB).

The Guardant360 TissueNext™ test can be ordered alongside our Guardant360 CDx liquid biopsy test and run only when liquid biopsy testing does not report actionable biomarkers. Guardant Health procures the tissue sample in parallel and runs the Guardant360 TissueNext test only when needed. This “blood-first, tissue-next” approach offers oncologists the most efficient way to perform complete genomic testing and ensure that as many patients as possible are identified who may benefit from biomarker-informed treatment. For more information, please visit our product webpage.

Note: Coverage information for patients.

The Guardant360 Response™ test is the first blood-only liquid biopsy that enables doctors to view molecular response, or changes in circulating tumor DNA (ctDNA) levels, from a simple blood draw to get an early indication of patient response to treatment. For doctors, knowing early and confidently if a patient’s treatment is working is critical in deciding whether to continue, stop, or explore other options. Studies across cancers and therapies show the Guardant360 Response test can predict treatment response 8 weeks earlier than current standard-of-care radiological and imaging scans.1-10

Note: Coverage information for patients.

Accelerating Clinical Trials

For pharmaceutical companies, Guardant360 CDx, Guardant360 LDT, and GuardantOMNI offer a way to accelerate clinical development programs through retrospective sample analysis, patient screening and clinical trial enrollment, 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 for research use only, 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. The 500-gene panel incorporates 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.

RESIDUAL DISEASE AND RECURRENCE
MONITORING FOR EARLY-STAGE CANCER

Guardant Health has leveraged the data from the tens of thousands of samples sequenced to date to help better understand cancer and shape new products. These deep biological insights have laid the groundwork for our latest breakthrough in the detection of residual disease and recurrence monitoring in early-stage cancer patients, starting with colorectal cancer (CRC).

The Guardant Reveal™ test is a blood-only liquid biopsy test that detects residual and recurrent disease in 7 days from a simple blood draw.

For oncologists, the test improves the management of early-stage CRC patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.11-16 The first indication of the test is early-stage CRC, where the unmet medical need exists given current tools, with additional cancer types to follow.

The commercially available test achieves high sensitivity (91%)17 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. Results are obtained from a simple blood draw and returned in as little as 7 days without the need for a tissue biopsy. Note: Coverage information for patients.

Early detection for Asymptomatic Individuals

Cancer screening is an effective way to detect cancer early, when it can most easily be treated. Unfortunately, many people today are not being screened inline with recommendations.

To help identify cancer at the earliest stages, we are developing a blood test that seeks to increase screening rates and overcome the challenges of current methods. By leveraging data from the tens of thousands of cancer patients we’ve already tested, we are developing a test with high sensitivity and specificity for early cancer detection. We are collaborating with multiple investigators at cancer centers around the world in pursuit of this goal.

Our first indication is colorectal cancer (CRC), where today 1 in 3 adults are not getting the recommended screening.18 We believe a simple blood test can improve these rates by overcoming the barriers associated with available methods, including colonoscopy and stool-based testing, which while effective, are time consuming and invasive —resulting in screening rates below the Centers for Disease Control and Prevention’s goal of 80%.19

The LUNAR-2 test aims to detect early-stage cancer in screen-eligible asymptomatic adults from a simple blood draw. The test has demonstrated high sensitivity and specificity for detecting CRC by interrogating genomic alterations, methylation, and fragmentomic signals from circulating tumor DNA in blood.20 Incorporating these biologically relevant epigenomic signatures is critical in increasing sensitivity for early-stage cancer.21

In 2019, we initiated the ECLIPSE trial to evaluate the performance of the LUNAR-2 test to detect early-stage CRC. One of the largest cancer screening studies of its kind, it is expected to complete enrollment in 2021 of approximately 10,000 individuals, and if successful, support submission to the FDA. Learn more about our ECLIPSE trial here.

REFERENCES:

  1. Raja R, Kuziora M, Philip Z. Brohawn PZ, et al. Early Reduction in ctDNA Predicts Survival in Patients with Lung and Bladder Cancer Treated with Durvalumab. Clin Cancer Res; 2018: 24(24): 6212-6222. DOI: 10.1158/1078-0432.CCR-18-0386.
  2. Aggarwal C,Thompson JC, Chien A, et al. Dynamic monitoring of circulating tumor DNA next-generation gene sequencing as a predictive biomarker of response and progression-free survival after pembrolizumab monotherapy in patients with advanced NSCLC.J Clin Oncol; 2019: 37:15 suppl, 3040-3040. DOI:10.1200/JCO.2019.37.15.
  3. Kim ST, Cristescu R, Bass AJ, et al. Comprehensive molecular characterization of clinical responses to PD-1 inhibition in metastatic gastric cancer. Nat Med; 2018: 24(9):1449-1458. DOI: 10.1038/s41591-018-0101-z.
  4. Shaw AT, Martini JF, Besse B, et al. Early circulating tumor (ct)DNA dynamics and efficacy of lorlatinib in patients (pts) with advanced ALK-positive non-small cell lung cancer (NSCLC). J Clin Oncol; 2019: 37:15_suppl, 9019-9019. DOI: 10.1200/JCO.2019.37.15.
  5. Pascual J, Cutts RJ, Kingston B, et al. Assessment of early ctDNA dynamics to predict efficacy of targeted therapies in metastatic breast cancer: Results from plasmaMATCH trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS5-02.DOI: 10.1158/1538-7445.SABCS20-PS5-02.
  6. Mack PC, Redman MW, Moon J, et al. Residual circulating tumor DNA (ctDNA) after two months of therapy to predict progression-free and overall survival in patients treated on S1403 with afatinib +/- cetuximab.J Clin Oncol; 2020: 38:15_suppl, 9532-9532. DOI: 10.1200/JCO.2020.38.15.
  7. Maron SB, Chatila WK, Millang BM, et al, Pembrolizumab with trastuzumab and chemotherapy (PTC) in HER2-positive metastatic esophagogastric cancer (mEG): Plasma and tumor-based biomarker analysis. J Clin Oncol; 2020: 38:15_suppl, 4559-4559. DOI: 10.1200/JCO.2020.38.15.
  8. Modi S, Park H, Murthy RK, et al. Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low-Expressing Advanced Breast Cancer: Results From a Phase Ib Study. J Clin Oncol; 2020: 38(17):1887-1896. DOI: 10.1200/JCO.19.02318.
  9. Zhang Q, Luo J, Wu S, et al. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov; 2020: 10:12, 1842-1853. DOI: 10.1158/2159-8290.CD-20-0047.
  10. Thompson JC, Carpenter EL, Silva BA, et al. Serial Monitoring of Circulating Tumor DNA by Next-Generation Gene Sequencing as a Biomarker of Response and Survival in Patients With Advanced NSCLC Receiving Pembrolizumab-Based Therapy. JCO Precis; 2021: 5, 510-524. DOI: 10.1200/PO.20.0032.
  11. Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncology. 2019; 5 (8): 1125-1131.
  12. Tie J, Wang Y, Tomasetti C, Li L, Springer S, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Science Translational Medicine. 2016; 8 (346): 346ra92.
  13. Tie J, Cohen J, Wang Y, et al. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer. JAMA Oncology. 2019; 5(12): 1710-1717.
  14. Peng J, Li Y, Mo S, Ma X, Hu X, Zhang L, et al. Prognostic value of circulating tumor DNA (ctDNA) detection during adjuvant chemotherapy in patients with stage III colorectal cancer: The interim report of a prospective, observational study.Journal of Clinical Oncology. 2020; 38, no.4_suppl.
  15. Tarazona N, Gimeno-Valiente F, Gambardella V, et al. Targeted next-generation sequencing of circulating-tumor DNA for tracking minimal residual disease in localized colon cancer. Annals of Oncology. 2019; 30 (11): 1804-1812.
  16. Reece M, Saluja H, Hollington P, Karapetis C, et al. The Use of Circulating Tumor DNA to Monitor and Predict Response to Treatment in Colorectal Cancer. Frontiers in Genetics. 2019; 10: 1118.
  17. Parikh A, Van Seventer E, Siravegna G, Hartwig A, et al. Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients. Clinical Cancer Research. April, 2021;  10.1158/1078-0432.CCR-21-0410
  18. Colorectal Cancer Facts & Figures. American Cancer Society. 2020-2022. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2017-2019.pdf. Accessed online February 19, 2021.
  19. Increasing Colorectal Cancer Screening: An Action Guide for Working with Health Systems. The Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2013.
  20. Kim ST, Raymond VM, Park JO, et al. Combined genomic and epigenomic assessment of cell-free circulating tumour DNA (ctDNA) improves assay sensitivity in early stage colorectal cancer (CRC). Proceedings: AACR Annual Meeting 2019; DOI: 10.1158/1538-7445.AM2019-916.
  21. Westesson O, Axelrod H, Dean J, He Y, Sample P, Zotenko E, et al. Abstract 2316: Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer. Proceedings: AACR Annual Meeting 2020; Cancer Res 2020;80; 10.1158/1538-7445.AM2020-2316.

In the event the test is not fully covered by insurance, patients may be eligible for financial assistance based on medical and financial need. To learn more, contact Guardant Health client services. For patients without insurance, the cash pay rate for Guardant360 CDx is $5,000 effective the first day of commercial launch September 28, 2020.

In the event the test is not fully covered by insurance, patients may be eligible for financial assistance based on medical and financial need. To learn more, contact Guardant Health client services.  For patients without insurance, the cash pay rate for Guardant360 TissueNext is $5,000 effective the first day of commercial launch June 22, 2021.

In the event the test is not fully covered by insurance, patients may be eligible for financial assistance based on medical and financial need. To learn more, contact Guardant Health client services.  For patients without insurance, the cash pay rate for Guardant360 Response is $5,000 effective the first day of commercial launch June 22, 2021.

In the event the test is not fully covered by insurance, patients may be eligible for financial assistance based on medical and financial need. To learn more, contact Guardant Health client services. For patients without insurance, the cash pay rate for Guardant Reveal is $3,500 effective the first day of commercial launch February 16, 2021.