Guardant Health Receives Regulatory Approval from Singapore's Health Sciences Authority for Guardant360® CDx blood test for patients with advanced solid cancers

• Guardant360^® CDx is a comprehensive genomic profiling blood test that provides critical information to help inform personalized treatment decisions for patients with advanced solid cancers  
  
  
• The liquid biopsy test is also approved as a companion diagnostic for TAGRISSO^® (osimertinib) in non-small cell lung cancer  
  
  
• This is the first blood test to be approved by Singapore's Health Sciences Authority for comprehensive genomic profiling for all solid tumors  

SINGAPORE, May 30, 2023 /PRNewswire/ -- Guardant Health, Inc. (Nasdaq: GH) announced today that Singapore's Health Sciences Authority (HSA) has granted regulatory approval of Guardant360^® CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers. The Guardant360 CDx test was also approved as a companion diagnostic to identify patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with TAGRISSO^® (osimertinib).  

Guardant360 CDx is the first blood test to be approved by Singapore's HSA for comprehensive genomic profiling for all solid tumors. Since being introduced as a laboratory developed test (LDT), the Guardant360 liquid biopsy has become widely accepted for blood-based CGP with more than 400 peer-reviewed publications.

"We are delighted to receive regulatory approval from HSA for our Guardant360 CDx test, as it supports the value liquid biopsy brings to oncologists and the patients they treat," said Simranjit Singh, CEO of Guardant Health AMEA. "With a simple blood draw from the patient, the Guardant360 CDx test provides CGP results in approximately seven days from receipt of the blood sample in the laboratory, enabling physicians to make faster treatment decisions compared to tissue biopsies. Our hope is that this approval will drive clinical adoption of liquid biopsy testing in Singapore and enable more patients to be matched to potentially life-changing precision medicines."

In 2020, over 23,600 people in Singapore were diagnosed with cancer and there were slightly over 12,000 cancer-related deaths. The most prevalent cancer types among men and women in Singapore include breast (15.5%), colorectal (15.1%) and lung (12.3%) cancer^[1]. According to the Singapore Cancer Registry Annual Report 2020, over 70% of all lung cancer cases among men and women were diagnosed at the advanced stage^[2]. Pancreatic, stomach and colorectal cancer cases among men and women were also diagnosed at the advanced stage respectively (71.9%, 62.1%, 58.3%)^[2]. To improve cancer outcomes in Singapore, Guardant Health AMEA is currently collaborating with National Cancer Centre Singapore and National University Cancer Institute, Singapore for several clinical trials using the Guardant360 test in efforts to accelerate clinical trial enrollment by identifying genomic biomarkers in patients with cancer. 

The Guardant360 CDx test was the first blood test to be approved by the U.S. Food and Drug Administration (FDA) for comprehensive genomic profiling for all solid tumors, and it is now FDA approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. In March 2022, the test was also granted regulatory approval by Japan's Ministry of Health, Labour and Welfare for tumor mutation profiling in patients with advanced solid cancers as well as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda® (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo® (nivolumab). In addition, Guardant Health is currently involved in multiple studies with drug development companies to develop Guardant360 CDx as a companion diagnostic for new therapies.

About Guardant360^® CDx

The Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping oncologists move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment.

The first FDA-approved blood test for complete genomic testing, Guardant360 CDx is approved as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO^® (osimertinib), RYBREVANT^® (amivantamab-vmjw), ENHERTU^® (fam-trastuzumab deruxtecan-nxki) or LUMAKRAS™ (sotorasib). It is also FDA approved to identify advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU™ (elacestrant). For more information, visit guardant360cdx.com.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling, with more than 400 peer-reviewed publications. It has been trusted by more than 12,000 oncologists, with more than 300,000 tests performed to date, and is broadly covered by Medicare and many private payers in the U.S., representing over 300 million lives.

About Guardant Health AMEA

Guardant Health AMEA is a wholly owned subsidiary of Guardant Health, Inc., a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360^®, Guardant360^® CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY™ tests for patients with advanced-stage cancer, and Guardant Reveal™ for patients with early-stage cancer. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealthamea.com and follow the company on LinkedIn, 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, 2021, and any current and periodic reports filed with 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.

References

^[1].  GLOBOCAN 2020 statistics available at https://gco.iarc.fr/today/data/factsheets/populations/702-singapore-fact-sheets.pdf  accessed on 20 May 2023

^[2].  Singapore Cancer Registry Annual Report 2020 statistics available at https://nrdo.gov.sg/publications/cancer accessed on 20 May 2023

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