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Company type | Private |
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Industry | Life sciences, biotechnology, medical diagnostics, healthcare industry |
Founded | 2020 [1] |
Founders |
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Headquarters | |
Key people | |
Number of employees | >3000 [4] (2021) |
Website | curative |
Curative Inc. is a health care startup company best known for scaling COVID-19 testing and COVID-19 vaccinations during the COVID-19 pandemic. [5] In September 2022, Curative Inc. launched Curative Insurance Company, a new health insurance plan featuring no copays and no deductibles. Headquartered in Austin, Texas, with employees throughout the United States, [6] the company was founded in January 2020 by Fred Turner, Isaac Turner (no relation), and Vlad Slepnev to create new diagnostic tests for sepsis and to improve outcomes for sepsis patients. [6] In response to an urgent, unmet need for COVID-19 test development and production in the United States, [7] [8] Curative rapidly shifted focus in March 2020. [9] [10] The company's research team developed a new test for SARS-CoV-2 that utilized oral swabs rather than nasopharyngeal swabs. [11] [12] The Curative test was designed with a scalable process and opportunities to reduce healthcare worker exposure risk, and therefore the amount of personal protective equipment (PPE) used. [8] [13] An independent manufacturing and supply chain model was adopted to avoid competing with existing COVID-19 test companies for limited supplies and laboratory capacity. [8] [10] [14]
The United States Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Curative's SARS-CoV-2 Assay in April 2020. [14] [15] By October 2020, nearly 10% of the SARS-CoV-2 tests performed in the United States had been performed by Curative, [3] and the company's weekly test processing capacity reached one million tests per week. [1] [10] As of November 2020, Curative had administered more than 2 million tests in the city of Los Angeles, [16] and expanded service offerings to include test site management, test accessibility enhancements (kiosks, mobile vans), and efficient results reporting through proprietary software. [1] [10]
Starting in December 2020, Curative expanded its service to include COVID-19 vaccine distribution, vaccination site management, and vaccine management system for communities in the United States. [17] [18] [19] As of December 2022, Curative has administered over 35 million tests and administered 2 million vaccines through a network of affiliated providers.[ citation needed ]
In Q3 of 2022, Curative began the process of shutting down its COVID-19 testing business while simultaneously launching an employer-based health insurance offering**. Utilizing a new model for health insurance, the Curative plan has one monthly premium, and there are no additional costs for accessing medical services and most pharmaceuticals within their broad-based physician network and extensive drug formulary*. The health insurance plan is designed to focus on preventative care and total well-being through proactive relationship management for members. The PPO-network health insurance plan launched in late September 2022 out of Austin, Texas, with plans to expand across other areas of the state in 2023.
As of December 31, 2022, Curative has shut down its COVID-19 services business. In 2023, the company fully shifted its operations to its health insurance business.
In January 2020, Fred Turner, Isaac Turner (no relation), and Vlad Slepnev co-founded Curative, Inc. to create new diagnostic tools for the detection and management of sepsis. [6] In response to nationwide (US) shortages of diagnostic test kits, laboratory testing capacity, and personal protective equipment (PPE) available to healthcare workers, the company abruptly pivoted to focus on COVID-19 in March 2020. [3] [20] Curative developed a self-collected oral fluid swab [21] as an alternative sample collection method, [22] an orthogonal supply chain approach [1] [23] to avoid competing with other SARS-CoV-2/COVID-19 test kit and laboratory analysis providers, [10] [8] created the Curative SARS-CoV-2 Assay, and began field tests using supervised self-collection in Los Angeles and Long Beach (California) in March. [24] In early April, Curative contacted UK government officials, offering to supply 50,000 test kits per week. [25]
The company's novel RT-PCR-based Curative SARS-CoV-2 Assay received FDA Emergency Use Authorization (EUA) in April 2020. [15] [26] At the time the EUA was issued, tests were processed through a partnership between Curative and KorvaLabs; [27] the testing capacity was 5,000 tests per day, and the test kit manufacturing capacity was 20,000 per day. [26] Later in April 2020, the United States Department of Defense signed a US$13M agreement with Curative to source Curative SARS-CoV-2 Assay kits for Air Force use, to establish a new laboratory facility with testing capacity of 50,000 tests per day within one week of signing, and to establish additional test locations across the US at a later date. [15] By October 2020, the company had expanded operations, processing nearly 10% of the COVID-19 tests performed in the United States. [13] As of March 2021, Curative operated COVID-19 testing laboratories in San Dimas (California), Austin (Texas), and Washington, D.C. [28] [29]
After the Emergency Use Authorization had been issued, health care workers used Curative SARS-CoV-2 Assay to observe, direct, self-collect oral and nasal swabs, and subsequent laboratory analysis. The Curative SARS-CoV-2 Assay were implemented for medical diagnostic programs in the United States, including United States Armed Forces operations, [15] [30] prisons, [7] [31] state-wide nursing home, long-term care facilities, [32] city-wide centers, regional testing centers, [33] [34] state-wide testing programs, [35] [36] and airports. [37] The company partnered with universities to provide on-campus testing to students and/or student athletes (Texas A&M, [38] Florida A&M (Bragg Stadium), [38] [39] Western New Mexico University, [40] Our Lady of the Lake [41] ).
In July 2020, the United States Department of Defense awarded a CARES Act-funded contract (US$42M) to Curative to provide 250,000 test kits for use at more than 100 military treatment facilities, and analysis and reporting services at Curative's high throughput laboratory. [30]
In August, Florida officials signed a contract with Curative to provide COVID-19 testing services for staff at nursing home and long-term care facilities located throughout the state. [32] Using a biweekly testing schedule, the test positivity rate for staff members decreased from 3% to 1%. [42] The state later decided not to renew the contract following a federal government decision to ship rapid antigen detection test kits directly to facilities. [43] Subsequently, "a majority of the state's 694 nursing homes" entered into agreements with Curative to resume testing of staff and expand testing to include residents. [43]
In January 2021, the FDA released a Safety Communication warning the public of the risk of false negative results with the Curative test. [44] [45] The communication restated the patient populations, test uses, and other conditions that were previously validated and allowed under the original Emergency Use Authorization (EUA). [46] [47]
In late 2020, Curative piloted a drive-through influenza vaccine clinic at an existing Los Angeles SARS-CoV-2 testing site to evaluate the potential community benefits of combining large scale testing and vaccination services. [48] In December 2020, Curative began COVID-19 vaccine distribution in Los Angeles. [33] [49] By February 2021, the company's vaccine distribution and vaccine clinic management service had expanded to sites in California, [49] [50] Delaware, [51] Florida, [52] Massachusetts, [53] Michigan, [54] Pennsylvania, [55] [56] and Texas. [57] In February 2021, Curative made its proprietary Vaccine Management System software available for use by U.S. communities, without cost. [18]
The Curative SARS-CoV-2 Assay is a nucleic acid amplification test (NAAT), reverse transcription polymerase chain reaction test (RT-PCR) for COVID-19. The test was designed to be scalable in response to changes in demand, and uses a healthcare worker observed, self-collected oral fluid swab to obtain specimens for testing. During the self-collection procedure, a person coughs before swabbing the inside of their mouth to collect oral fluid for testing; the cough serves to release virus (if present) from the respiratory tract. The self-collected oral fluid swab method is less invasive than the nasopharyngeal swab method, [25] reduces the risk to healthcare workers by eliminating close contact, [10] and reduces the need to change PPE frequently. [10] The reduction in PPE usage was an advantage during the global shortage of medical materials related to the COVID-19 pandemic. [3] [14]
In July 2021, Curative switched over to using Abbott's Alinity m SARS-CoV-2 Assay and requested the FDA revoke EUA clearance for its original test. [58]
After developing a scalable SARS-CoV-2 diagnostic test and laboratory facilities, Curative worked to make COVID-19 testing as accessible as possible. [59] The company partnered with cities, regions, and states across the United States, setting up and managing different types of testing sites (including drive-through, mobile vans, [60] kiosks, and walkup [61] locations) in an effort to reach general and at-risk populations. As of October 2021, Curative managed 16,557 testing sites nationwide, including mobile van, kiosk, walk-up, and drive-through sites. [62]
In late 2020, Curative became one of the first companies to administer COVID-19 vaccines in Los Angeles, after vaccines from Pfizer and Moderna became publicly available in the United States. [49] Curative used the scaling principles that enabled it to quickly create mass and mobile COVID-19 testing capabilities to create a vaccine distribution and vaccination management strategy. [17] As of February 2021, the company had partnered with communities in California, [49] [50] Delaware, [51] Florida, [52] Massachusetts, [53] Michigan, [54] Pennsylvania, [55] [56] and Texas, [57] [63] administering over 2,000,000 vaccinations[ citation needed ] across 170 sites. Vaccination sites operated by the company include traditional, large scale (also known as mass vaccination), drive-through, [50] and mobile vans. [17] [53] [64] Also in February 2021, Curative made its proprietary Vaccine Management System software available to communities in the United States without cost. [18]
In 2020, Curative, Inc. was named a LinkedIn Top Startup, [65] and was the recipient of the 2020 dot.LA Summit Award “Pivot of the Year”. [20] In 2021, Curative was named Best Medtech Startup in the Medtech Breakthrough Awards, [66] was a finalist in the Pandemic Response category, and received an honorable mention in the Health category as part of our 2021 World Changing Ideas Awards by Fast Company. [67] [68] The company also received an honorable mention for Fast Company’s Best Place to Work for Innovators Award. [69]
In immunology, seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization, including vaccination. During infection or immunization, antigens enter the blood, and the immune system begins to produce antibodies in response. Before seroconversion, the antigen itself may or may not be detectable, but the antibody is absent. During seroconversion, the antibody is present but not yet detectable. After seroconversion, the antibody is detectable by standard techniques and remains detectable unless the individual seroreverts, in a phenomenon called seroreversion, or loss of antibody detectability, which can occur due to weakening of the immune system or decreasing antibody concentrations over time. Seroconversion refers the production of specific antibodies against specific antigens, meaning that a single infection could cause multiple waves of seroconversion against different antigens. Similarly, a single antigen could cause multiple waves of seroconversion with different classes of antibodies. For example, most antigens prompt seroconversion for the IgM class of antibodies first, and subsequently the IgG class.
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.
On December 31, 2019, China announced the discovery of a cluster of pneumonia cases in Wuhan. The first American case was reported on January 20, and President Donald Trump declared the U.S. outbreak a public health emergency on January 31. Restrictions were placed on flights arriving from China, but the initial U.S. response to the pandemic was otherwise slow, in terms of preparing the healthcare system, stopping other travel, and testing. The first known American deaths occurred in February. On March 6, 2020, Trump allocated $8.3 billion to fight the outbreak and declared a national emergency on March 13. The government also purchased large quantities of medical equipment, invoking the Defense Production Act of 1950 to assist. By mid-April, disaster declarations were made by all states and territories as they all had increasing cases. A second wave of infections began in June, following relaxed restrictions in several states, leading to daily cases surpassing 60,000. By mid-October, a third surge of cases began; there were over 200,000 new daily cases during parts of December 2020 and January 2021.
COVID-19 testing involves analyzing samples to assess the current or past presence of SARS-CoV-2, the virus that cases COVID-19 and is responsible for the COVID-19 pandemic. The two main types of tests detect either the presence of the virus or antibodies produced in response to infection. Molecular tests for viral presence through its molecular components are used to diagnose individual cases and to allow public health authorities to trace and contain outbreaks. Antibody tests instead show whether someone once had the disease. They are less useful for diagnosing current infections because antibodies may not develop for weeks after infection. It is used to assess disease prevalence, which aids the estimation of the infection fatality rate.
A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID‑19).
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The Janssen COVID‑19 vaccine, sold under the brand name Jcovden, is a COVID‑19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company Johnson & Johnson.
SARS-CoV-2, the virus that causes COVID-19, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten the development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.
The COVID-19 vaccination campaign in the United States is an ongoing mass immunization campaign for the COVID-19 pandemic in the United States. The Food and Drug Administration (FDA) first granted emergency use authorization to the Pfizer–BioNTech vaccine on December 10, 2020, and mass vaccinations began four days later. The Moderna vaccine was granted emergency use authorization on December 17, 2020, and the Janssen vaccine was granted emergency use authorization on February 27, 2021. By April 19, 2021, all U.S. states had opened vaccine eligibility to residents aged 16 and over. On May 10, 2021, the FDA approved the Pfizer-BioNTech vaccine for adolescents aged 12 to 15. On August 23, 2021, the FDA granted full approval to the Pfizer–BioNTech vaccine for individuals aged 16 and over.
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COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. As of November 2022, 40 vaccines are authorized by at least one national regulatory authority for public use:
In many countries a variety of unfounded conspiracy theories and other misinformation about COVID-19 vaccines have spread based on misunderstood or misrepresented science, religion, and law. These have included exaggerated claims about side effects, misrepresentations about how the immune system works and when and how COVID-19 vaccines are made, a story about COVID-19 being spread by 5G, and other false or distorted information. This misinformation, some created by anti-vaccination activists, has proliferated and may have made many people averse to vaccination. This has led to governments and private organizations around the world introducing measures to incentivize or coerce vaccination, such as lotteries, mandates, and free entry to events, which has in turn led to further misinformation about the legality and effect of these measures themselves. {{TOC limit|4}
Over the course of the COVID-19 pandemic, COVID-19 vaccine mandates have been enacted by numerous states and municipalities in the United States, and also by private entities. In September 2021, President Joe Biden announced that the federal government would take steps to mandate COVID-19 vaccination for certain entities under the authority of the federal government or federal agencies. Most federal mandates thus imposed were either overturned through litigation, or withdrawn by the administration, although a mandate on health care workers in institutions receiving Medicare and Medicaid funds was upheld. All federal mandates were lifted when the national emergency was declared to have ended in May 2023. A small number of states have gone in the opposite direction, through executive orders or legislation designed to limit vaccination mandates.
'*A Baseline Visit is required of members in order to qualify for no copays and no deductibles for in-network care and preferred prescriptions throughout the calendar year.
'** Curative Insurance Company