Home > News > featured news > Guardant Health Receives Regulatory Approval from Singapore's Health Sciences Authority for Guardant360® CDx blood test for patients

Industrial Impact

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

PRNewswire | May 30, 2023 | Read time : 05:00 min

Guardant Health, Inc. announced that Singapore's Health Sciences Authority has granted regulatory approval of Guardant360® CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling 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 with epidermal growth factor receptor alterations who may benefit from treatment with TAGRISSO®.

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 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 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® and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo®. 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 Guardant Health

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.

Spotlight

More featured news

Spotlight

Related News

Medical, Industry Outlook

Introducing the Anbio ADL i1910: An Elegant CLIA Analyzer for Comprehensive Clinical Testing

PRNewswire | July 12, 2023

Anbio, a leading provider of innovative diagnostic solutions, proudly presents the Anbio ADL i1910, a fully automated, compact, and affordable CLIA analyzer designed to transform the landscape of clinical diagnostics. With its cutting-edge technology and versatile capabilities, the ADL i1910 offers a comprehensive range of qualitative and quantitative testing options for analytes in human serum, plasma, whole blood, and urine samples. The ADL i1910 utilizes a direct chemiluminescence method based on acridinium ester, ensuring accurate and reliable results across a wide array of applications. Whether it's hormone detection, myocardial disease screening, infectious disease diagnostics, or tumor-related antigen analysis, the ADL i1910 delivers exceptional performance and meets the diverse needs of modern healthcare professionals. Key Features of the Anbio ADL i1910 Extensive Assay Menu: The ADL i1910 boasts an impressive range of 49 developed assays, allowing for both qualitative and quantitative testing of analytes. This comprehensive immunodiagnostic solution enables healthcare providers to access critical information efficiently. High Throughput: With a remarkable throughput of up to 120 tests per hour, the ADL i1910 significantly enhances laboratory productivity. Rapid turnaround times enable healthcare providers to make timely and informed decisions, ultimately improving patient care. Compact Footprint: Anbio understands the importance of laboratory space. The ADL i1910 has been meticulously designed to occupy minimal space, making it suitable for laboratories of all sizes. Its small footprint ensures that valuable space can be optimized for other essential equipment. User-Friendly Interface: The ADL i1910 features an intuitive graphic user interface with a large color touch screen, simplifying operation and minimizing the learning curve. The user-friendly design ensures ease of use for both experienced professionals and new users, enhancing overall efficiency. "Anbio is proud to introduce the ADL i1910, a breakthrough CLIA analyzer that revolutionizes clinical diagnostics," said Jack Davis, Chief Business Officer at Anbio. "With its advanced technology, extensive assay menu, and impressive throughput, the ADL i1910 provides healthcare professionals with a reliable and efficient solution for a wide range of diagnostic applications." The Anbio ADL i1910 is set to transform the field of clinical diagnostics, empowering healthcare providers with a cost-effective and comprehensive solution. About Anbio Biotechnology Anbio Biotechnology is devoted to making contributions for human health and has never stopped our goal to innovate in life sciences. Driven by continuous technical development and integration, resulting from close cooperation with prestigious institutes across the world. Anbio always strives to provide total solutions in clinical diagnosis field, by offering extensive diagnostic products including laboratory and point-of-care products.

Industry Outlook

FOXO Technologies Launches Bioinformatics Services to Revolutionize Epigenetic Data Analysis

Businesswire | July 20, 2023

FOXO Technologies Inc.™ a leader in the field of commercializing epigenetic biomarker technology, announced the launch of its cutting-edge Bioinformatics Services to accelerate breakthroughs in biology, biotechnology, and healthcare, and redefine the growing field of epigenetic research. FOXO’s Bioinformatics Services offers a comprehensive platform of advanced data solutions tailored to meet the specific needs of clients in academia, healthcare, and pharmaceutical research. Through its innovative suite of bioinformatic tools, FOXO will enable its clients to increase the speed and accuracy with which they process, analyze, and interpret data sets, accelerate discoveries, and advance their understanding of complex diseases. “The launch of FOXO’s Bioinformatics Services marks a significant milestone for FOXO Technologies and the field of epigenetic research,” said Tyler Danielson, interim CEO and Chief Technology Officer of FOXO. “Epigenetics plays a key role in gene regulation and the interplay between lifestyle and environmental factors on biological systems. However, harnessing the full potential of epigenetic data has long been hindered by the challenges of data processing, analysis, and interpretation. With the introduction of our Bioinformatics Services, we aim to eliminate these barriers and empower researchers, clinicians, and other organizations to accelerate their research.” Any researcher or research group that seeks to leverage DNA methylation microarrays can benefit from FOXO’s Bioinformatics Services. These services include ingesting and processing raw DNA methylation microarray data, performing sample- and probe-level quality control, and securely delivering publication-ready figures and results. FOXO’s expert team also offers the addition of advanced bioinformatic analyses including epigenome wide association studies (EWAS), and even AI-driven epigenetic biomarker development. These services can be applied to Illumina’s existing human and mouse DNA Methylation arrays, which cover over 935,000 and 285,000 CpG sites respectively. By leveraging state-of-the-art algorithms and world-class experts, the company’s bioinformatics platform can rapidly deliver accurate and high-quality data tailored to the needs of each client. “Epigenetics is a nuanced science. Through years of experience, our team has developed niche expertise in bioinformatics with respect to epigenetics, specifically. Researchers who wish to incorporate epigenetic data into their studies can save valuable time and effort through our services offering,” says Brian Chen, Chief Science Officer. As a leader in the field, FOXO remains committed to advancing epigenetic research and catalyzing breakthroughs in health and longevity. With Bioinformatic Services, FOXO is also opening the door to new research collaborations with industry and academic leaders. About FOXO Technologies Inc. FOXO is at the forefront of commercializing epigenetic biomarker technology. Their mission is to utilize the power of epigenetics and artificial intelligence to generate data-driven insights that promote optimal health and longevity outcomes for individuals and organizations alike.

Medical

DNA-Encoded Libraries (DELs) and NanoBRET Target Engagement Assays Accelerate Drug Discovery

Businesswire | August 03, 2023

A new study demonstrates how the combination of DNA-encoded libraries (DELs) and NanoBRET Target Engagement technology can accelerate early-stage drug discovery. Reported in Cell Chemical Biology, researchers from Promega Corporation and WuXi AppTec generated new chemical probes from molecules identified through a DEL screen. This research opens new opportunities to develop novel NanoBRET Target Engagement Assays aimed at many understudied classes of proteins, rapidly accelerating “hit to lead” efforts in identifying new potential therapeutics. Generating Novel Chemical Probes from DELs DELs are increasingly popular tools used to rapidly screen billions of molecules for early-stage drug discovery. Each molecule is tagged with a short DNA “barcode” that can be used to identify those that successfully bind to a given target. In the Cell Chemical Biology paper, scientists from Promega and WuXi AppTec aimed to develop new chemical probes using molecules selected from these massive pools. These probes would be used in a NanoBRET Target Engagement Assay, a tool for studying the interaction between a chemical compound and its target protein in live cells. The authors screened 16.8 billion compounds from WuXi AppTec’s 41 established DELs against aurora kinase A, a protein implicated in the invasive growth of certain cancers. They identified two representative “hits” that bound to the target and developed a method to replace the DNA barcode of each “hit” with a fluorophore. The fluorophore is responsible for the light signal generated in a NanoBRET assay in live human cells. The team found that this new probe could be used effectively to characterize novel inhibitors targeting aurora kinase A, providing critical engagement characteristics such as affinity, selectivity and cellular permeability. “It was very clever of the authors to appreciate that the DEL read-out not only identified a chemical binder for a protein, but also a place to attach a tracer,” says Aled Edwards, Chief Executive of the Structural Genomics Consortium, a public-private partnership that develops open-access chemical probes to support drug discovery and development. “One can only imagine what could be if there were DEL hits for all human proteins.” Accelerating Drug Discovery The authors demonstrate that DELs can benefit chemical biologists who require verification of live cell target engagement for their protein of interest. This is particularly beneficial for understudied protein classes that may not have existing chemical probes. Additionally, they note that the NanoBRET assays help drug discovery researchers accelerate their workflow by providing data used to identify the most promising leads. They conclude, “Our findings support that DEL-derived BRET probes facilitate prioritization of not only the chemical matter identified from the DEL but may also serve as general live-cell screening tools for surveying broader chemotypic diversity at the target of interest.” Read the open access paper, “DELs enable the development of BRET probes for target engagement studies in cells”. About Promega Corporation Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s portfolio of over 4,000 products supports a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. These tools and technologies have grown in their application over the last 45 years and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors.