Guardant Health Announces Collaboration with Janssen to Develop Liquid Biopsy Companion Diagnostic
Guardant Health (Nasdaq: GH) announced a collaboration with Janssen Biotech to obtain regulatory approval for the Guardant360 CDx as a companion diagnostic for amivantamab, targeting non-small cell lung cancer (NSCLC) treatment in the U.S., Canada, Japan, and Europe. Guardant360, a liquid biopsy test, analyzes 74 genes to enhance genotyping rates and personalized therapy for cancer patients. The test is already covered by Medicare for most advanced solid tumors, aiding in treatment decisions.
- Strategic collaboration with Janssen Biotech could enhance market presence and revenue opportunities in NSCLC.
- Guardant360 CDx positioned as a promising companion diagnostic, potentially improving treatment outcomes.
- Regulatory approval process introduces uncertainty and potential delays in commercialization.
- Reliance on collaboration success with Janssen Biotech for effective market entry could pose risks.
REDWOOD CITY, Calif., July 08, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) today announced a strategic collaboration with Janssen Biotech, Inc. (Janssen) to pursue regulatory approval and commercialization of the Guardant360® CDx as a companion diagnostic for amivantamab, an investigational EGFR-MET bispecific antibody being studied in the treatment of non-small cell lung cancer (NSCLC). The agreement covers the United States, Canada, Japan, and Europe.
“Studies continue to show that the full promise of personalized medicine remains out of reach for the majority of patients with advanced non-small cell lung cancer who are not receiving complete genotyping before starting therapy, thus impeding their treatment with the most appropriate therapy,” said AmirAli Talasaz, Ph.D., Guardant Health President. “Our Guardant360 liquid biopsy has been shown to overcome the barriers associated with tissue, and increase genotyping rates, which we believe will ultimately help ensure that all patients who are eligible for potentially life-changing therapies are identified from the start.”
The Guardant360 blood test is increasingly being used to guide treatment in metastatic cancer, as the number of treatment-relevant genomic alterations continues to grow. Using next-generation sequencing, the Guardant360 test analyzes 74 genes using cell-free tumor DNA from patient blood samples. The Guardant360 test is broadly covered by Medicare for use across the vast majority of advanced solid tumors, including patients with metastatic NSCLC.
About 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. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the regulatory approvals to be pursued by Guardant Health under its collaboration with Janssen Biotech and the potential benefits and advantages of the Guardant360 test, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in its other reports filed with the Securities and Exchange Commission. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.
Investor Contact:
Carrie Mendivil
investors@guardanthealth.com
Media Contact:
Anna Czene
press@guardanthealth.com
Becky Lauer
becky.lauer@uncappedcommunications.com
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