Biopharma Solutions

Guardant Health is your trusted partner for precision oncology drug development. Our portfolio of innovative solutions spans comprehensive liquid biopsy tests, including our FDA-approved companion diagnostic (CDx), clinical development services, and our extensive real-world clinical-genomic platform. These tailored solutions can help optimize and accelerate your clinical programs, each step of the way.

We are proud to partner with biopharma companies, more than 60 to date, to support their efforts in bringing the next generation of cancer therapeutics to patients sooner.

Comprehensive Liquid Biopsy Tests

We offer the most validated comprehensive liquid biopsy platform on the market. Our Guardant360® CDx, Guardant360 lab developed test (LDT), and GuardantOMNI liquid biopsy tests can help identify patients whose cancer has the right molecular profile for your clinical program, and more easily monitor their response to investigational drugs. Our Guardant Reveal liquid biopsy test helps you identify new drug development opportunities for adjuvant and neoadjuvant management of early-stage cancers, with evidence of residual disease or recurrence. With our liquid biopsy tests, you can:

  • Accelerate clinical trial enrollment: Research1, shows that our liquid biopsy tests can accelerate trial enrollment compared to traditional tissue biopsy, providing faster results in only 7 days instead of weeks, with similar objective response rates and progression-free survival.
  • Understand tumor evolution and mechanisms of resistance: More actionable alterations are revealed because of our tests’ high success rates and ability to detect heterogeneously-distributed mutations which are often missed by single-locus tissue analysis, giving you deeper insights into how tumors evolve, and mechanisms of resistance.
  • Monitor and stratify response: Track patient tumor burden over time with serial blood draws for earlier insights into who is responding, and who is not, and why.
  • Validate targets: Use our tests and data from our biobank of specimens to validate novel targets, and understand epidemiology and prevalence.
  • Access more patients: We can also work with you and our ordering physicians to refer patients with alterations of interest for whom a trial, or a newly approved therapy, could be appropriate. Such referrals are made only with physician and patient consent, in a HIPAA-compliant manner.
  • Reduce per patient screen costs: Simultaneously screen patients for many biomarkers using our larger panel tests.

The Guardant360 CDx liquid biopsy test offers biopharma companies an FDA-approved companion diagnostic across all solid tumor cancers. We collaborate with partners to add CDx claims to this validated platform, including current programs underway with: Amgen, AstraZeneca, Janssen, and Radius Health, Inc.

The test is FDA approved for 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). If you are a healthcare provider looking for information about Guardant360 CDx, please visit our product website.

The Guardant360 LDT offers the same technology as our approved CDx test, with 80+ genes and full coverage of NTRK1-3 fusions, HRR-related genes, and blood tumor mutational burden (bTMB).

Since being introduced, the Guardant360 LDT has become widely accepted for blood-based CGP with more than 200 peer-reviewed publications including over 60 clinical outcomes studies. It has been trusted by more than 9,000 oncologists with more than 150,000 tests performed to date.

GuardantOMNI is the world’s largest commercial deep liquid biopsy. For research use only (RUO), it 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 genes being evaluated in cancer drug development pipelines and biomarkers for immuno-oncology applications, including tumor mutational burden.

With GuardantOMNI, you can also monitor patient response to investigational drugs or combinations of drugs, and perform retrospective analyses on banked plasma samples.

The Guardant Reveal™ test is the first blood-only liquid biopsy test that detects residual and recurrent disease in 7 days from a simple blood draw. The test detects any circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and detects recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.1-6 

The commercially available test achieves industry-leading sensitivity (91%)7 for correctly detecting ctDNA and enables biopharma companies and academic researchers to identify new drug development opportunities to serve patients. The first indication of the test is early-stage CRC with additional cancer types to follow. For more information, visit the product section.

  • NRG-G1005 COBRA Study: Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Stage II Colon Cancer
  • SU2C Study: Circulating Tumor DNA to identify Micrometastatic Disease for Treatment in Stage III Colon Cancer
  • PEGASUS Trial: Post-Surgical Liquid Biopsy-Guided Treatment of Stage III and High-Risk Stage II Colon Cancer Patients

Clinical Development Services

Drug development faces many unknowns. How many patients have the biomarker being enrolled? Where can these patients be found? How quickly can they be enrolled? Who is a reliable companion diagnostic partner? Is a drug working? How many patients are responding? What is the duration of response? What stops a drug from working? Our clinical development services can help provide peace of mind.

Our retrospective banked sample analysis service, GuardantEXPLORE, lets you look back to move forward. We have processed more than 30,000 samples for 50+ companies to date. Join us in a creative collaboration and benefit from:

  • Earlier insights: Find the genomic profile of your early responders and differentiate between molecular response and pseudo-progression.
  • Comprehensive analysis: Work with our Bioinformatics and Medical Affairs teams to define optimal biomarkers, prepare data for scientific conferences and publications, and build scientific consensus among KOLs.
  • Identify what’s next: Chart a path forward to the next phase of development.

The GuardantCOMPANION set of services is for prospective sample screening for clinical trial enrollment and companion diagnostic development. We can help you find more patients faster and de-risk your FDA path.

  • Blood-based enrollment: Screen patients using a simple blood draw. Preferred by physicians and patients alike, enroll patients in almost real-time based on their current genomic profiles, not archival tissue results.
  • Global footprint: Identify patients across your global network of trial sites, using our experience from over 400 trial sites in 30+ countries.
  • Proven track record: Collaborate with a trusted partner who has multiple IDEs, PMA, and sPMA submissions for companion diagnostics to our name.

GuardantConnect lets you accelerate patient identification for precision oncology clinical trials with an infrastructure that allows real-time connectivity with treating oncologists. The program leverages the vast commercial reach of Guardant360 within the United States to drive awareness of ongoing studies at the point-of-care, to overcome historical challenges associated with biomarker screening.

Using our real-time database of patients receiving Guardant360 liquid biopsy assays, identify patients who may be eligible for a clinical trial, including those who may be progressing on standard of care therapy, as well as the up to 50% of patients who fail tissue-based testing1.

Real-World Clinical-Genomic Platform

The GuardantINFORM platform enables biopharma companies to accelerate research and development of the next generation of cancer therapeutics by offering an in-silico resource that combines de-identified longitudinal clinical information and genomic data collected from our Guardant360 liquid biopsy test. With data from over 135,000 patients, our real-world clinical-genomic dataset of advanced cancer patients is one of the largest of its kind.

This robust dataset offers real-world clinical-genomic insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers including non-small cell lung, breast, colon, and prostate. Notable applications for the GuardantINFORM platform include:

  • Targeted drug development: Identify, characterize, and prioritize cohorts of patients with biomarker-defined cancers and in need of treatment options for potential new drug development indications and label expansions.
  • Clinical trial optimization: Incorporate real-world clinical-genomic data into clinical trial design, control arm simulation, clinical operations activities, and clinical development decision-making.
  • Post-marketing studies: Conduct health outcomes and safety studies of on- and off-label use of marketed therapies using real-world market insights and estimates of progression-free and overall survival in biomarker-defined cancers.

Contact us to learn more
about our BioPharma Solutions

For more information, you can also contact us at biopharmabd@guardanthealth.com

REFERENCES:

  1. 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 CancerJAMA Oncology. 2019; 5 (8): 1125-1131.
  2. 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 cancerScience Translational Medicine. 2016; 8 (346): 346ra92.
  3. 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 CancerJAMA Oncology. 2019; 5(12): 1710-1717.
  4. 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.
  5. 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.
  6. 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 CancerFrontiers in Genetics. 2019; 10: 1118.
  7. 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. Under Review. Data on file.