Company type | Public |
---|---|
| |
Industry | Molecular diagnostics |
Founded | 1995Marlborough, Massachusetts | in
Founders |
|
Headquarters | Madison, Wisconsin, U.S. |
Key people |
|
Products | Cologuard, Oncotype DX, Oncotype MAP |
Revenue | US$2.08 billion (2022) |
US$−594 million (2022) | |
US$−624 million (2022) | |
Total assets | US$6.23 billion (2022) |
Total equity | US$3.04 billion (2022) |
Number of employees | 6,400 (Dec 2022) |
Subsidiaries | Subsidiary List
|
Website | exactsciences |
Footnotes /references [1] [2] |
Exact Sciences Corp. is a 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. [3]
Exact Sciences was founded in 1995 in Marlborough, Massachusetts, by Stanley Lapidus and Anthony Shuber as a company focused on the development of a non-invasive test for colorectal cancer. The company eventually went public with an initial offering on the NASDAQ in 2001. In the early years, there was much speculation that the company would be acquired by a competitor or exit the market; during this time the company's share price fell to less than one dollar. [4] [5] [6]
A significant turnaround in the company's fortunes began with the announcement of a mutual collaboration and licensing agreement between Exact Sciences and the Mayo Clinic in June 2009. In the same year, the company appointed Kevin Conroy as CEO & president and moved its head office to Madison, Wisconsin. [7] [8] [9] [10]
In August 2014, Exact Sciences received premarket approval from the Food and Drug Administration for the use and marketing of its flagship product, Cologuard. This breakthrough heralded the beginning of a period of rapid growth for Exact Sciences and the start of its first foray into the acquisitions market. [11]
In August 2017, the company made its first major acquisition when it purchased Sampleminded, a healthcare information technology company based in Salt Lake City, Utah, for $3.2 million. This was followed by the January 2018 announcement that Exact Sciences had completed a $690 million convertible bond offering and the revelation that the company was to acquire Armune Bioscience, a cancer diagnostic developer based in Kalamazoo and Ann Arbor, Michigan (announced during that year's J.P Morgan Healthcare Conference). [12] [13] Third-quarter financial reports revealed the price of the Armune Bioscience acquisition to be valued at $12 million, plus $17.5 million in incentives for certain milestones. [14] Later, in October 2018, Exact Sciences announced its purchase of Biomatrica, a developer of sample preservation technology based in San Diego, California. [15] [16] [17] Financial reports revealed the purchase price to be $20 million with an additional $20 million in incentives for certain milestones.[ citation needed ]
In summer 2019, Exact Sciences opened a new 169,000 square feet lab and warehouse facility to expand its testing capacity for Cologuard and, in its largest acquisition yet, announced its intention to buy Genomic Health, a genetic cancer detection company based in Redwood City, California, for $2.8 billion. The reason given for this latest acquisition was to both expand Exact Sciences' product portfolio through the addition of Genomic Health's OncotypeIQ suite of precision tests, and expand into other markets outside the US on the back of Genomic Health's existing network. [18] [19] [20] [21] The deal with Genomic Health led to the opening of Exact Sciences offices in the United Kingdom, France, Germany, Italy and Japan, and the foundation of Exact Sciences International, with its headquarters initially in Geneva and later in Zug, Switzerland.[ citation needed ]
In March 2020, Exact Sciences purchased Paradigm Diagnostics and Viomics, two companies based in Phoenix, Arizona that would expand their lab testing and research and development capabilities. [22] Later, in October 2020, the company again announced a round of acquisitions - this time of Thrive Earlier Detection Corp. (based in Cambridge, Massachusetts) and Base Genomics (based in Oxford, England), two companies specializing in one of Exact Sciences' pipeline areas - blood-based cancer screening. [23]
Exact Sciences responded to the 2020 COVID-19 pandemic by temporarily refocusing a portion of its diagnostic capacity to testing for the disease. The company received FDA regulatory approval to provide home testing kits in April 2020, becoming one of the first companies in the U.S. to do so. [24]
In early 2021, Exact Sciences announced its acquisition of Ashion Analytics and plans to collaborate in research with TGen, the City Of Hope's Genomics Institute. [25] This news came shortly after the company's decision to purchase an exclusive-use license of TGen's proprietary liquid biopsy-based test technology, Tardis. [26]
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
Exact Sciences |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Since 2009, Exact Sciences has maintained a collaboration with Mayo Clinic for its current and future products. [27] In 2009, Exact Sciences also completed a licensing agreement with Hologic for its molecular detection platform. [28] In April 2017, Exact Sciences and MDxHealth agreed to share technology on a variety of epigenetics and molecular diagnostics applications for five years. [29] In August 2018, Exact Sciences and Pfizer announced an agreement through 2021 to co-promote Cologuard. [30] In November 2018, Exact Sciences announced a partnership with Epic Systems for order entries. [31]
Exact Sciences has, since 2015, been sponsor of the Cologuard Classic, a professional golf tournament on the PGA Tour Champions tournament circuit held annually at the Catalina Course of the Omni Tucson National Resort, in Tucson, Arizona.[ citation needed ]
Product | Cancer targeted | Purpose | Launch year | Availability | Additional information |
---|---|---|---|---|---|
Cologuard™ | Colorectal | Detection of colorectal neoplasia associated DNA markers and for the presence of occult haemoglobin in human stool | 2014 | US only | In August 2014, the U.S. Food and Drug Administration (FDA) approved the company's at-home multitarget stool DNA screening test called Cologuard, for the detection of colorectal cancers and pre-cancers. [32] [33] [34] [35] [36] This test has a false positive rate of 13%. [37] |
Oncotype DX® AR-V7 Nucleus Detect | Prostate | Detection of acquired resistance to AR-targeted therapy via liquid biopsy assay that analyzes circulating tumor cells in a patient's blood | 2018 | US only | Developed by Epic Sciences and commercialised through a partnership with Exact Sciences in the United States. |
Oncotype DX® Breast DCIS Score | Breast | Genomic testing of a patient’s risk for a local recurrence of ductal carcinoma in situ or invasive carcinoma | 2011 | Over 90 countries | |
Oncotype DX® Breast Recurrence Score | Breast | Genome-based, comprehensive, individualized risk assessment for early-stage invasive breast cancer in adjuvant and neoadjuvant settings | 2004 | Over 90 countries | Since 2015 access to Oncotype DX Breast Recurrence Score testing has been available to all eligible NHS patients in England [38] |
Oncotype DX® Colon Recurrence Score | Colorectal | Genome-based test to quantify the risk of recurrence of patients with anatomic stage II, MMR-P and stage III A/B colon cancers | 2010 | Over 90 countries | |
Oncotype DX® Genomic Prostate Score | Prostate | Genomic assay testing for men with clinically low- or intermediate-risk cancer to help make treatment decisions at the time of diagnosis | 2013 | Over 90 countries | |
Oncotype MAP™ Pan Cancer Tissue | Multiple | Tumor profiling to aid therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer | 2020 | US only | |
Pipeline products include esophageal, breast, lung, liver, and pancreatic cancer testing. The company is also working with the Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers. [39] Other initiatives focus on:[ citation needed ]
Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or through biochemical analysis to measure specific protein output. In a medical setting, genetic testing can be used to diagnose or rule out suspected genetic disorders, predict risks for specific conditions, or gain information that can be used to customize medical treatments based on an individual's genetic makeup. Genetic testing can also be used to determine biological relatives, such as a child's biological parentage through DNA paternity testing, or be used to broadly predict an individual's ancestry. Genetic testing of plants and animals can be used for similar reasons as in humans, to gain information used for selective breeding, or for efforts to boost genetic diversity in endangered populations.
F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the fifth-largest pharmaceutical company in the world by revenue and the leading provider of cancer treatments globally. In 2023, the company’s seat in Forbes Global 2000 was 76.
Fecal occult blood (FOB) refers to blood in the feces that is not visibly apparent. A fecal occult blood test (FOBT) checks for hidden (occult) blood in the stool (feces).
A stool test is a medical diagnostic technique that involves the collection and analysis of fecal matter. Microbial analysis (culturing), microscopy and chemical tests are among the tests performed on stool samples.
Cetuximab, sold under the brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion.
Personalized medicine, also referred to as precision medicine, is a medical model that separates people into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease. The terms personalized medicine, precision medicine, stratified medicine and P4 medicine are used interchangeably to describe this concept though some authors and organisations use these expressions separately to indicate particular nuances.
In medicine and statistics, sensitivity and specificity mathematically describe the accuracy of a test that reports the presence or absence of a medical condition. If individuals who have the condition are considered "positive" and those who do not are considered "negative", then sensitivity is a measure of how well a test can identify true positives and specificity is a measure of how well a test can identify true negatives:
Myriad Genetics, Inc. is an American genetic testing and precision medicine company based in Salt Lake City, Utah, United States. Myriad employs a number of proprietary technologies that permit doctors and patients to understand the genetic basis of human disease and the role that genes play in the onset, progression and treatment of disease. This information is used to guide the development of new products that assess an individual's risk for developing disease later in life, identify a patient's likelihood of responding to a particular drug therapy, assess a patient's risk of disease progression and disease recurrence, and measure disease activity.
Illumina, Inc. is an American biotechnology company, headquartered in San Diego, California, and it serves more than 155 countries. 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.
A non-profit genomics research institute.
23andMe Holding Co. is a publicly trading personal genomics and biotechnology company based in South San Francisco, California. It is best known for providing a direct-to-consumer genetic testing service in which customers provide a saliva sample that is laboratory analysed, using single nucleotide polymorphism genotyping, to generate reports relating to the customer's ancestry and genetic predispositions to health-related topics. The company's name is derived from the 23 pairs of chromosomes in a diploid human cell.
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. As of 2023, cancer is the second leading cause of death in the United States.
Dr. Paul R. Billings is a distinguished American doctor, lecturer, researcher, professor, and consultant on genetic information. His research interests include the impact of genomic data on society, the integration of genomics with diagnostics in health and medical care, and individualized genomic medicine. He is the author of over 250 publications and has appeared on talk shows such as The Oprah Winfrey Show and 60 Minutes. He is currently the CEO and Director of Biological Dynamics.
Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients, and in agricultural biosecurity similarly to monitor crop- and livestock disease, estimate risk, and decide what quarantine measures must be taken.
DiaSorin is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics and since July 2021, it is also active in the Life Science business. The group was founded in 2000 and is headquartered in Saluggia, Italy. Its production is at several plants located in Europe and the United States: Saluggia and Gerenzano (Italy), Dietzenbach (Germany), Stillwater, Minnesota (US), Dartford (UK). Following the acquisition of Luminex, the company acquired five additional production plants located in the United States and in Canada (Toronto). The company is a constituent of the FTSE MIB index.
Genomic Health was a company focusing on genetic research specifically in cancer detection, based out of Redwood City, California. The company was acquired by and merged with Exact Sciences Corporation in 2019.
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.
Grail is an American biotechnology company in Menlo Park, California. It is a subsidiary of Illumina started as a startup seeking to develop an early cancer screening test for people who do not have symptoms.
Guardant Health is an American biotechnology company based in Palo Alto, California. Co-founders Helmy Eltoukhy and AmirAli Talasaz serve as co-chief executive officers.