 | |
| Company type | Public |
|---|---|
| Nasdaq: GH | |
| Industry | Biotechnology |
| Founded | 2012 |
| Founders | |
| Headquarters | , United States |
Key people |
|
Number of employees | 1,400 (2022) |
| Website | guardanthealth |
Guardant Health, Inc. is an American biotechnology company based in Palo Alto, California. Co-founders Helmy Eltoukhy and AmirAli Talasaz serve as co-chief executive officers.
The American biotechnology company Guardant Health, which produces liquid biopsy tests to detect cancer from mutations and other modifications in blood samples, [1] was co-founded by Helmy Eltoukhy and AmirAli Talasaz during 2012–2013. [2] [3] According to John Dorfman of the Pittsburgh Tribune-Review , Talasaz and Eltoukhy discovered a technique which "involves detecting and monitoring tumor fragments circulating in the patient's bloodstream", as an alternative to traditional tissue biopsies. [4] The duo met at Stanford University in 2002 and worked together at Illumina, until Talasaz left in 2012. [5]
Early in its history, Guardant Health acquired multiple patents by Swiss biochemist Maurice Stroun, who became a founding advisor. [6] In 2015, the company had 40 patents and was developing a blood test to "identify all classes of actionable tumor genomic alterations", according to VentureBeat . Guardant Health said the test would be the "first and only comprehensive biopsy-free cancer test available". [7] In 2016, the company announced clinical trial results demonstrating the test "detected disease-associated genetic mutations that were also present in 94% to 100% of the solid tissues extracted from the study's subjects". [8]
The company's U.S. initial public offering in 2018 raised $237.5 million, [9] [10] valuing Guardant Health at $3.3 billion. [11] In December 2022, Guardant Health announced the results of a study on its blood-based screening test for colorectal cancers, which it began in 2019. The study included 20,000 participants identified as having an average risk for colorectal cancer. Results showed the test was 83 percent accurate at detecting the presence of cancer, with a 10 percent false positivity rate. Bloomberg reported that the results were short of the 85 percent accuracy rate that investors expected, and the company's stock price fell following the news. A competitor's stool-based test for the same cancer is 92 percent accurate. [12]
Guardant Health raised approximately $550 million in funding in its first six years. [13] [14] Aydin Senkut was an early investor. [15] The company raised $30 million in 2014, [16] including $10 million from Sequoia Capital. [17] In 2015, Guardant Health raised $50 million in a venture round led by Lightspeed Venture Partners. The funding was used for infrastructure and growing operations. [7] Guardant Health's Series D round in January 2017 raised approximately $100 million, [18] [19] bringing total funding to $190 million. [20]
In 2017, the company raised $360 million in a round led by a subsidiary of SoftBank Group. [13] [21] The funding supports an attempt to sequence the DNA of 1 million cancer patients in five years, bring to market a blood test to screen for early signs of cancer, and a blood test to detect residual disease in cancer survivors. Guardant Health and SoftBank formed the joint venture to expand the use of Guardant360 in Africa, Asia, and the Middle East. [3] [20] The joint venture, called Guardant Health AMEA, launched in 2018 and was purchased by Guardant Health for approximately $178 million in 2022. [22]
Guardant Health earns revenue from test fees purchased by third-party insurance companies and drug developers. [23] The company generated $374 million in revenue in 2021. Guardant Health has approximately 1,400 employees, [24] including approximately 900 in California, as of 2022. [2]
In July 2020, Guardant Health signed a lease for two levels at the former Hewlett Packard Enterprise headquarters in Palo Alto. [25] The lease agreement was the largest in Silicon Valley for the year to date, [26] and the company has since moved its corporate headquarters to the approximately 250,000-square-foot Palo Alto space. [25] [27] The offices in Torrey Pines, San Diego are Guardant Health's largest outside Palo Alto and Redwood City at 37,000 square feet. The company has labs and 55 employees in San Diego as of 2022. [2] [28]
Talasaz has served on Guardant Health's board of directors since January 2013, occupying the chairman role until August 2021. [29] He was the company's president and chief technology officer, as of 2014. [16] [30] He held the president, chief financial officer, and chief operating officer positions in 2019, when he and Eltoukhy collectively held 12 percent of the company's stock. [23] [31] In 2021, both spent $10 million to purchase additional shares of the company. [4]
Talasaz and Eltoukhy are co-chief executive officers as of 2022. [2] Richard B. Lanman joined in 2014 and was the chief medical officer (CMO) as of 2017. [6] Craig Eagle was named CMO in 2021. [32]
Guardant Health has partnered with the National Cancer Institute and large pharmaceutical companies on product improvement. [1] The business began selling Guardant360 tests to oncologists in 2014. Medicare began covering the test for select lung cancer patients in 2018, prior to Food and Drug Administration approval (which is not required) [7] in 2020. [33] [34] By 2019, the Guardant360 genomic test, which requires two blood samples and examines 73 genes, [11] [35] [36] had been used for 50 types of cancer by 6,000 oncologists to assess samples from 100,000 patients. [37] The test had also been used by 50 biopharmaceutical companies for drug development purposes. [23] In late 2019, the Guardant360 test received expanded Medicare coverage for solid tumors. [38]
Guardant Health launched Project Lunar, which studied hundreds of "pre-symptomatic, high-risk" people for breast, colorectal, lung, ovarian, and pancreatic cancer, in May 2016 in collaboration with the University of California, San Francisco, the Seoul-based Samsung Medical Center, the University of Colorado, and the University of Pennsylvania. [6] The GuardantOMNI test launched in 2017 and has been used for biopharmaceutical research. [23] Guardant Health launched the early-stage cancer assay called Lunar for academic and biopharmaceutical research in 2019. [39]
Japan's Ministry of Health, Labour and Welfare granted regulatory approval of Guardant360 CDx as a companion diagnostic "for identifying patients with metastatic non-small cell lung cancer who may benefit from treatment with Lumakras (sotorasib)" in late 2021. The agency granted regulatory approval of the test in 2022 for patients with "advanced solid tumors" and 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)". [40]
In 2021, Guardant Health introduced Guardant Reveal, the first blood-only liquid biopsy test for the detection of residual and recurrent disease in colorectal cancer (CRC). The test helps oncologists improve the management of early-stage CRC patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging. [41]
In 2022, Guardant Health enrolled the first patient in the Screening for High-Frequency Malignant Disease (SHIELD) Lung study to evaluate its blood-based screening technology for lung cancer. [42] Guardant Health also launched a colon cancer detection test called Shield. [43] The company partnered with the Vall d'Hebron Institute of Oncology to launch the first blood-based cancer testing services in Barcelona in mid 2022. [44] Guardant Health also licensed cancer tests to the clinical laboratory company Adicon for research testing in China. [45] [46] In 2024 Guardant's Shield, colon cancer test received FDA approval. [47] [48]
Guardant Health sued Foundation Medicine over patents in 2019–2020. [49] [50] In 2021, Guardant Health licensed intellectual property to Foundation Medicine for $25 million in a settlement. [51] In 2022, Illumina sued Guardant Health and its co-founders in Delaware federal court over trade secrets. Illumina accused the duo of incorporating Guardant Health anonymously in 2011 while working at Illumina and stealing confidential documents related to DNA sequencing technology to acquire 35 patents. [5] [52] In response, Guardant Health rejected the claims, accused Illumina of attempting to eliminate competitors, and asked for a suit dismissal. [53] [54] In 2023, the two companies settled, signed a long-term supply agreement, and agreed to share specimen samples for cancer research. [27]
A biopsy is a medical test commonly performed by a surgeon, an interventional radiologist, or an interventional cardiologist. The process involves the extraction of sample cells or tissues for examination to determine the presence or extent of a disease. The tissue is then fixed, dehydrated, embedded, sectioned, stained and mounted before it is generally examined under a microscope by a pathologist; it may also be analyzed chemically. When an entire lump or suspicious area is removed, the procedure is called an excisional biopsy. An incisional biopsy or core biopsy samples a portion of the abnormal tissue without attempting to remove the entire lesion or tumor. When a sample of tissue or fluid is removed with a needle in such a way that cells are removed without preserving the histological architecture of the tissue cells, the procedure is called a needle aspiration biopsy. Biopsies are most commonly performed for insight into possible cancerous or inflammatory conditions.
Illumina, Inc. is an American biotechnology company, headquartered in San Diego, California. Incorporated on April 1, 1998, Illumina develops, manufactures, and markets integrated systems for the analysis of genetic variation and biological function. The company provides a line of products and services that serves the sequencing, genotyping and gene expression, and proteomics markets, and serves more than 155 countries.
Minimal residual disease (MRD), also known as Molecular residual disease, is the name given to small numbers of cancer cells that remain in a person either during or after treatment when the patient is in remission. Sensitive molecular tests are either in development or available to test for MRD. These can measure minute levels of cancer cells in tissue samples, sometimes as low as one cancer cell in a million normal cells, either using DNA, RNA or proteins.
A circulating tumor cell (CTC) is a cancer cell from a primary tumor that has shed into the blood of the circulatory system, or the lymph of the lymphatic system. CTCs are carried around the body to other organs where they may leave the circulation and become the seeds for the subsequent growth of secondary tumors. This is known as metastasis, responsible for most cancer-related deaths.
The objective of cancer screening is to detect cancer before symptoms appear, involving various methods such as blood tests, urine tests, DNA tests, and medical imaging. The purpose of screening is early cancer detection, to make the cancer easier to treat and extending life expectancy. In 2019, cancer was the second leading cause of death globally; more recent data is pending due to the COVID-19 pandemic.
Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA in the bloodstream that is not associated with cells. ctDNA should not be confused with cell-free DNA (cfDNA), a broader term which describes DNA that is freely circulating in the bloodstream, but is not necessarily of tumor origin. Because ctDNA may reflect the entire tumor genome, it has gained traction for its potential clinical utility; "liquid biopsies" in the form of blood draws may be taken at various time points to monitor tumor progression throughout the treatment regimen.
A liquid biopsy, also known as fluid biopsy or fluid phase biopsy, is the sampling and analysis of non-solid biological tissue, primarily blood. Like traditional biopsy, this type of technique is mainly used as a diagnostic and monitoring tool for diseases such as cancer, with the added benefit of being largely non-invasive. Liquid biopsies may also be used to validate the efficiency of a cancer treatment drug by taking multiple samples in the span of a few weeks. The technology may also prove beneficial for patients after treatment to monitor relapse.
Foundation Medicine, Inc. is an American company based in Cambridge, Massachusetts, which develops, manufactures, and sells genomic profiling assays based on next-generation sequencing technology for solid tumors, hematologic malignancies, and sarcomas.
Exact Sciences Corp. is an American molecular diagnostics company based in Madison, Wisconsin specializing in the detection of early stage cancers. The company's initial focus was on the early detection and prevention of colorectal cancer; in 2014 it launched Cologuard, the first stool DNA test for colorectal cancer. Since then Exact Sciences has grown its product portfolio to encompass other screening and precision oncological tests for other types of cancer.
CAPP-Seq is a next-generation sequencing based method used to quantify circulating DNA in cancer (ctDNA). The method was introduced in 2014 by Ash Alizadeh and Maximilian Diehn’s laboratories at Stanford, as a tool for measuring Cell-free tumor DNA which is released from dead tumor cells into the blood and thus may reflect the entire tumor genome. This method can be generalized for any cancer type that is known to have recurrent mutations. CAPP-Seq can detect one molecule of mutant DNA in 10,000 molecules of healthy DNA. The original method was further refined in 2016 for ultra sensitive detection through integration of multiple error suppression strategies, termed integrated Digital Error Suppression (iDES). The use of ctDNA in this technique should not be confused with circulating tumor cells (CTCs); these are two different entities.
Maurice Stroun was a Swiss researcher and professor at the University of Geneva in the Department of Plant Biochemistry and Physiology. He is known for first hypothesizing and demonstrating the existence of disease-specific circulating nucleic acids as well as first developing techniques for the detection of tumor-related characteristics of circulating DNA and RNA in plasma and serum, or liquid biopsies as this field is now known.
Luis Alberto Diaz, Jr. is the Head of the Division of Solid Tumor Oncology in Memorial Sloan Kettering’s Department of Medicine.
Helmy Eltoukhy is an American scientist and a businessperson who co-founded startups Avantome and Guardant Health. He is best known for his contributions to genomics, semiconductor DNA sequencing, and personalized medicine. His startups were acquired by Illumina in 2008. Avantome was founded to develop and commercialize semiconductor-based DNA sequencing, during the race for the $1,000 genome. Guardant Health was founded to pioneer non-invasive liquid biopsy approaches for cancer diagnosis, monitoring, personalized medicine treatment, and research.
Richard Burnham Lanman is an American biotechnology entrepreneur, physician scientist, and naturalist. His contributions relate to improving diagnosis and utilization of less invasive medical procedures, most recently as Global Chief Medical Officer at Guardant Health, Inc., a precision oncology company that developed a blood test replacing invasive tissue biopsies to sequence tumor DNA and improve cancer treatment selection. Lanman has worked in five different medical specialties, oncology, cardiology, endocrinology, pulmonology, and psychiatry, as well as historical ecology, and has authored or co-authored 130 peer-reviewed scientific publications.
Cancer Likelihood in Plasma (CLiP) refers to a set of ensemble learning methods for integrating various genomic features useful for the noninvasive detection of early cancers from blood plasma. An application of this technique for early detection of lung cancer (Lung-CLiP) was originally described by Chabon et al. (2020) from the labs of Ash Alizadeh and Max Diehn at Stanford.
GRAIL, Inc. is an American biotechnology company based in Menlo Park, California. It was previously a subsidiary of Illumina started as a startup seeking to develop an early cancer screening test for people who do not have symptoms. Grail was spun-out from Illumina on June 24, 2024.
Epitope Detection in Monocytes (EDIM) is a technology that uses the innate immune system's mechanisms to detect biomarkers or antigens in immune cells. It is a non-invasive form of liquid biopsy, i.e. biopsy from blood, which analyzes activated macrophages (CD14+/CD16+) for disease-specific epitopes, such as tumor cell components.
Aldo Carrascoso is a Filipino entrepreneur known for founding Veem and Jukin Media. He founded InterVenn Biosciences, an American pharmaceutical and biotechnology company, with Carolyn Bertozzi and served as its chief executive officer for six years.
AmirAli Talasaz is an entrepreneur in the field of clinical diagnostics. He founded the startup Auriphex Biosciences and is co-founder and co-chief executive officer of Guardant Health.
Dxcover Limited is a Scottish company which was founded in 16 May 2016. It is based in Glasgow, UK. It combines novel hardwares with artificial intelligence algorithms. Patients' blood samples are analysed by scientists to detect the presence of diseases. It is a clinical stage liquid biopsy company and uses artificial intelligence algorithms for early detection of cancers and other diseases to improve survival rates. Its marketplaces are located in the US, UK and EU. The company aims to detect early stage of cancers.
Guardant, meanwhile, has raised $550 million since it was founded...
The Food and Drug Administration approved Guardant360 CDx in early August for use in a range of solid tumors