Guardant Health Announces Collaboration With Boehringer Ingelheim to Develop Companion Diagnostic for Detection of Specific Mutations in Advanced Lung Cancer

Rhea-AI Summary

Guardant Health (Nasdaq: GH) announced a collaboration with Boehringer Ingelheim to develop the Guardant360® CDx liquid biopsy as a companion diagnostic for zongertinib, an investigational treatment for non-small cell lung cancer (NSCLC). The blood test will identify NSCLC patients with HER2 mutations who may benefit from zongertinib treatment.

According to Guardant Health's chairman, approximately 40,000 people worldwide are diagnosed annually with NSCLC with HER2 mutations, who often respond poorly to standard treatments. The Guardant360 CDx is already FDA-approved for comprehensive liquid biopsy in advanced solid tumors and serves as a companion diagnostic for multiple NSCLC targeted therapies and breast cancer therapy targeting ESR1 mutations.

Positive

• New collaboration expands Guardant360 CDx test's market potential in NSCLC diagnostics
• Addresses significant market of 40,000 annual NSCLC patients with HER2 mutations
• Builds on existing FDA approvals and Medicare coverage for Guardant360 CDx

Negative

• Zongertinib is still investigational and pending regulatory approval
• Revenue impact dependent on successful drug approval and adoption

Insights

Medical Research Analyst

This strategic collaboration marks a significant advancement in precision oncology for NSCLC patients. The partnership to develop Guardant360 CDx as a companion diagnostic for zongertinib addresses a critical unmet need in HER2-mutated NSCLC treatment. The potential impact is substantial, considering 40,000 patients globally are diagnosed with HER2-mutated NSCLC annually. The liquid biopsy approach offers a less invasive alternative to tissue biopsies, potentially accelerating treatment decisions. Guardant360 CDx's established FDA approval record and Medicare coverage suggest a streamlined pathway for this new indication. The test's ability to identify specific HER2 mutations through blood samples could significantly improve patient identification and treatment access, particularly important given the poor response rates to standard therapies in this patient population.

Financial Analyst

This collaboration with Boehringer Ingelheim strengthens Guardant Health's position in the companion diagnostic market. The deal expands the company's CDx portfolio beyond its current FDA-approved indications, potentially creating a new revenue stream. With broad Medicare coverage already in place, commercialization barriers are reduced. The addressable market of 40,000 patients annually represents significant revenue potential, especially considering the high-value nature of companion diagnostic testing. The partnership with a major pharmaceutical company like Boehringer Ingelheim validates Guardant's technology platform and could lead to additional collaborations. This move aligns with the growing trend toward precision medicine and could positively impact Guardant's market share in the oncology diagnostics space.

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a collaboration with Boehringer Ingelheim to pursue the regulatory approval and commercialization of the Guardant360^® CDx liquid biopsy as a companion diagnostic (CDx) for zongertinib, an investigational covalent tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC).

As part of the collaboration, the Guardant360 CDx blood test will provide comprehensive genomic profiling (CGP) of tumors to identify actionable biomarkers that allow targeted therapy selection and help identify NSCLC patients with HER2 mutations who may be eligible for treatment with Boehringer’s investigational zongertinib after it is approved by health authorities.

“Many of the 40,000 people diagnosed worldwide every year with NSCLC with a HER2 mutation may respond poorly to standard chemotherapy and immunotherapy,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “This collaboration with Boehringer Ingelheim to pursue approval of the Guardant360 CDx test as a companion diagnostic would allow oncologists, using a simple blood draw, to identify patients with advanced lung cancer who have HER2 mutations targeted by zongertinib and could benefit from this investigational therapy.”

The first FDA-approved comprehensive liquid biopsy for all advanced solid tumors, Guardant360 CDx is approved as a companion diagnostic for multiple targeted therapies in NSCLC. It is also the only FDA-approved CDx to identify patients eligible for breast cancer therapy targeting ESR1 mutations and has broad commercial and Medicare coverage.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, 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. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2023, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241218898088/en/

Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Michael Weist

press@guardanthealth.com

+1 317-371-0035

Source: Guardant Health, Inc.

FAQ

What is the purpose of Guardant Health's collaboration with Boehringer Ingelheim for GH stock?

The collaboration aims to develop Guardant360 CDx as a companion diagnostic for zongertinib in NSCLC patients, potentially expanding GH's market in cancer diagnostics.

How many patients could benefit from Guardant Health's (GH) HER2 mutation testing annually?

According to the announcement, approximately 40,000 people worldwide are diagnosed annually with NSCLC with HER2 mutations who could benefit from this testing.

What current FDA approvals does Guardant Health's (GH) Guardant360 CDx test have?

Guardant360 CDx is FDA-approved for comprehensive liquid biopsy in advanced solid tumors, as a companion diagnostic for multiple NSCLC targeted therapies, and for identifying breast cancer patients eligible for ESR1 mutation-targeted therapy.

How does Guardant Health's (GH) Guardant360 CDx test identify eligible patients?

The test uses a simple blood draw to perform comprehensive genomic profiling of tumors to identify actionable biomarkers and HER2 mutations that may indicate eligibility for zongertinib treatment.