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Guardant Health develops blood-based cancer diagnostics and sells tests to healthcare providers and research institutions. Its flagship product, Guardant360, uses a liquid biopsy to analyze tumor DNA circulating in a patient’s blood to detect mutations and guide treatment decisions for advanced cancer. The company is expanding into early detection and recurrence monitoring, with tests designed to be non-invasive and data-rich for cancer management. Compared with competitors, Guardant Health emphasizes a widely adopted, FDA-approved liquid biopsy platform with broad cancer-type coverage and a focus on providing actionable genomic insights to clinicians. Its goal is to improve cancer outcomes by enabling non-invasive, data-driven decision making across stages of disease and over time.
Industries
Data & Analytics
Biotechnology
Healthcare
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Palo Alto, California
Founded
2012
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Total Funding
$2.1B
Above
Industry Average
Funded Over
9 Rounds
Professional Development Budget
Performance Bonus
Hikma welcomes FDA approval of Guardant360(R) Liquid CDx. London, 22 June 2026 - Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical group, welcomes the recent U.S. Food and Drug Administration (FDA) approval of Guardant360(R) Liquid CDx, the largest FDA-approved liquid biopsy panel, developed by Guardant Health, Inc. (Nasdaq: GH). This development was highlighted at the sidelines of the 5th Annual International Oncology Forum IOF 2026 in the UAE, where Hikma and Guardant Health were platinum sponsors. Guardant360(R) Liquid CDx is the largest FDA-approved liquid biopsy panel (a type of test that detects cancer-related genomic material from a simple blood draw), offering a less invasive alternative to traditional tissue-based biomarker testing. Powered by Guardant's proprietary Smart Platform, the test integrates both genomic and epigenomic profiling from a single blood draw. It analyses a tumour's DNA mutations, allowing clinicians to make better-informed clinical decisions for patients with advanced cancer originating from solid organs. The test delivers a 100x wider genomic footprint and a several-fold increase in sensitivity for circulating tumour DNA (ctDNA) detection compared to the previous Guardant360 CDx. With this approval, the seven previously FDA-approved companion diagnostic indications for Guardant360 CDx transfer to Guardant360 Liquid CDx. Hikma signed an exclusive agreement with Guardant Health, Inc. in 2024 for the commercialisation and marketing of its liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumour mutation profiling across all solid cancers in the Middle East and North Africa (MENA). Guardant is the only precision oncology company to offer a complete portfolio of cancer solutions in the region. Commenting on this milestone, Mazen Darwazeh, Hikma's Executive Vice Chairman and Deputy CEO - MENA, said: "Our collaboration with Guardant Health is very important for introducing next-generation diagnostics in the MENA region, that can redefine cancer care. The recent FDA approval of Guardant360(R) Liquid CDx brings a highly advanced solution to clinicians, enabling a deeper understanding of tumour biology to guide precise treatment decisions. As a trusted and experienced partner in the region with a strong oncology portfolio, Hikma remains committed to enhancing access to precision medicine and delivering better outcomes for patients battling cancer." "Guardant Health is the only precision oncology company to have three solutions receive FDA approval, reinforcing our leadership in comprehensive molecular profiling across the cancer continuum. With our proprietary Smart Platform, clinicians have access to advanced molecular insights to inform their treatment selection decisions, marking a new era in advanced cancer care," said Simranjit Singh, Chief Executive Officer, Guardant Health AMEA. Results from Guardant360 Liquid CDx are available in as little as seven days once the sample is received in the laboratory, supporting more informed treatment decisions for patients regardless of tissue availability or line of therapy. Approved as a companion diagnostic across non-small cell lung cancer, colorectal cancer, and advanced breast cancer, it delivers a comprehensive view of tumour biology from a single blood draw.
Guardant Health dodges additional damages in TwinStrand bio, U of Washington patent suit. NEW YORK - In a decision handed down on Tuesday by the US District Court for the District of Delaware, Guardant Health dodged trebled damages in a patent infringement case involving TwinStrand Biosciences and the University of Washington. Get the full story with 360Dx Premium. Only $95 for the first 90 days. Full site access Interest-based email alerts Premium Access - Trial Offer $95.00 for 3 month
Guardant Health, Nuvalent ink oncology companion diagnostic development pact. NEW YORK - Guardant Health announced on Thursday that it has entered into a multi-year strategic collaboration with biopharma company Nuvalent to develop and potentially commercialize companion diagnostics for oncology. Get the full story with 360dx Premium. Only $95 for the first 90 days. Full site access Interest-based email alerts Premium Access - Trial Offer $95.00 for 3 month
Inside Quest Diagnostics' daytime kidney care lab strategy. In this exclusive interview, Quest Diagnostics' Ines Dahne-Steuber discusses their daytime kidney care lab strategy with MLO Editor in Chief, Christina Wichmann. April 6, 2026 Ines Dahne-Steuber is Vice President and General Manager of Kidney Care at Quest Diagnostics. Most recently, Ines served as Chief Operating Officer for Guardant Health. Prior to that, she served as SVP of Operational Excellence and President of Spectra Labs for Fresenius Medical Care. Ines previously worked at Quest Diagnostics from 2005-2015 in several roles, including as VP of Process Excellence and Healthcare IT. She earned bachelor's and master's degrees in Modern Chinese and Romance Studies from Humboldt-University in Berlin, Germany. MLO: dialysis patients have unique and often complex testing needs. How has Quest Diagnostics adapted its daytime operations to better support this population, and what operational changes have made the biggest impact on patient care? Dahne-Steuber: Quest operates major clinical laboratories all over the U.S., so Mlo Online is well positioned to serve patients in their local communities, wherever they live. To best accommodate the unique needs of dialysis patients, Mlo Online has chosen to perform testing at all 16 participating Quest Diagnostics labs during daytime operations so that staff can give these samples special attention without impacting other patient testing commitments. Dialysis patients have unique physiologies, which lead to more clotted samples. These clots can impact testing performance and need to be managed diligently.
Guardant Health (GH) and Verana Health announces new partnership. Noor Ul Ain Rehman Guardant Health, Inc. (NASDAQ:GH) is one of the best high growth healthcare stocks to buy now. Guardant Health, Inc. (NASDAQ:GH) and Verana Health announced on March 24 a new partnership aimed at allowing biopharmaceutical researchers to access the combined resources of Guardant's clinicogenomic testing data and Verana's regulatory-grade, therapeutic-specific EHR curated datasets to expedite the development of new therapies and enhance ongoing patient care. Management stated that the collaboration provides extensive datasets that would allow research scientists to easily understand and validate correlations between molecular biomarkers, treatment decisions, and clinical outcomes. Craig Eagle, MD, Guardant Health, Inc. (NASDAQ:GH) chief medical officer, stated that the real-world data partnership with Verana marks a considerable milestone in the company's mission to advance novel therapies, in particular cancer, with data. He added that allowing "biopharmaceutical researchers the ability to connect detailed information about tumor biology and therapy response with real-world patient outcome data" would accelerate the discovery of new biomarker-based therapies for patients, helping make the drug development process more economical. Guardant Health, Inc. (NASDAQ:GH) is a precision oncology company specializing in treating cancer through vast data sets, proprietary blood-based tests, and advanced analytics. The company's solutions include recurrence detection, early detection, and treatment selection. While Need2learnchinese acknowledge the potential of GH as an investment, Need2learnchinese believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see its free report on the best short-term AI stock.
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Industries
Data & Analytics
Biotechnology
Healthcare
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Palo Alto, California
Founded
2012
Find jobs on Simplify and start your career today