This species is particularly invasive because the eggs are able to remain dormant in dry conditions for months, spreading by way of people and transported goods, before hatching when it rains. Hickey B, Teneza-Mora N, Lumsden J, Reyes S, Sedegah M, Garver L, Hollingdale MR, Banania JG, Ganeshan H, Dowler M, Reyes A, Tamminga C, Singer A, Simmons A, Belmonte M, Belmonte A, Huang J, Inoue S, Velasco R, Abot S, Vasquez CS, Guzman I, Wong M, Twomey P, Wojnarski M, Moon J, Alcorta Y, Maiolatesi S, Spring M, Davidson S, Chaudhury S, Villasante E, Richie TL, Epstein JE. According to the study, researchers have bioengineered male History of anaphylactic or severe response to mosquito bites, retinal or visual field changes, or known allergy to the antimalarial chloroquine phosphate, which will be used to treat subjects developing malaria after CHMI. 5 doses of approximately 200 noninfected bites (200-400 bites total) from irradiated uninfected mosquitoes (mock-immunization). Get more great content like this delivered right to you! AP News - Video on social media doesnt show genetically modified mosquitoes Reuters - Fact Check-Video shows an aphid, not a genetically modified mosquito released by Bill Gates Logically - Bill Gates' genetically modified mosquitoes are responsible for mosquito-borne viruses in Florida and are part of the next planned Want CNET to notify you of price drops and the latest stories? Healthy adults (male or non-pregnant, non-breastfeeding female) 18-50 years of age (inclusive). WebThe Bill & Melinda Gates Foundation has found the work so promising it has invested nearly $38 million into genetic strategies to stop mosquitoes from transmitting diseases like malaria and dengue fever. In short, we found that the Bill and Melinda Gates Foundation did award grants to biotech company Oxitec for its work to develop a new strain of genetically 2020 Jun 17;15(6):e0233840. Yes, I also want to receive the CNET Insider newsletter, keeping me up to date with all things CNET. It's a bold bid to curb The release of the insects, however, leads to the fear that such dangerous hybrid mosquito species could emerge. An edited video with the caption the biggest unexpected truth bomb ever on live TV shows Gates saying: Genetically modified organisms, and were injecting them into little kids arms, we just shoot them right in the vein (here). Oxitec is genetically modifying mosquitoes to combat malaria-carrying mosquitoes. 5 infectious Anopheles stephensi mosquito bites carrying infectious Plasmodium falciparum sporozoites within a controlled clinical environment. 3 to 7 doses of approximately 200 noninfected bites (200-400 bites total) from irradiated, uninfected mosquitoes (true-immunization). He is currently on sabbatical. GMO crops have their genetic material modified to give new properties - for instance to be resistant to disease or drought - but some environmentalists believe they are a threat to ecosystems. Positive sickle cell screening test, including evidence of sickle trait. Please make a tax-deductible gift today. Any history of malaria infection or travel to a malaria endemic region within 6 months prior to first immunization. A stream of papers and reports has argued that a release of any genetically modified mosquito should be preceded by years of careful groundwork, including an exhaustive public debate to win the hearts and minds of the local population. Oxitecs second-generation A. aegypti are the only mosquitoes to have been released in the U.S. to date, and they are not funded by the Gates Foundation, a spokesperson for the company told Snopes, adding that the Florida project is fully funded by Oxitec. MRCU could not be reached for comment. Challenge occurs directly after screening. The announcement, made at a press briefing in London, has taken aback opponents of GM mosquitoes and surprised many researchers in the field of genetic control of insect vectors. To combat this, Oxitec researchers identified a protein called tetracycline Trans-Activator Variant as a tool to suppress mosquito populations. He argued that medicines have trials and checks to ensure they are safe and the same logic should be applied to GMOs, rather than rejecting a technology that promises to solve nutrition problems, solve productivity problems, solve crop disease problems for African farmers. Oxitec, the recipient of a grant from the Bill & Melinda Gates Foundation (BMGF) for self-limited mosquito field trials, in April 2021 launched its pilot project in Under these parameters, the EPA required that the study be conducted over a two-year period in Monroe County, Florida, beginning in the summer of 2020 and in Harris County, Texas, beginning in 2021, for a total of 6,600 acres across the two states. (The Gates name was probably included because the Bill & Melinda Gates Foundation provided $19.7 million for a project to develop and test GM mosquitoes, according to Science.) A second grant of nearly $1.4 million in September 2020 was awarded as part of a year-long project to prepare and engage partners for potential self-limited mosquito trials specific to malaria in Africa and North America. For general information, Learn About Clinical Studies. Able and willing to provide written informed consent. "Genetically-modified mosquitoes are showing promise in controlling other vector-borne diseases, so we look forward to exploring their use alongside complementary interventions for malaria.". This particular video shows Gates rocking as he answers questions, leading some Facebook users to question his movements. Alphey emphasizes that in designing the trial, Oxitec has worked with the Mosquito Research and Control Unit (MRCU) of the Cayman Islands, a British overseas territory. PLoS Pathog. That's the plan. When Marrian is not reporting, she is probably binge watching, playing saxophone or eating hot pot. Madison Dapcevich is a former writer for Snopes. GM Mosquito Trial Strains Ties in Gates-Funded Project. The purpose of this grant was described as follows: transfer a self-limiting genetic platform into a malaria vector for future application in Meso-America and the Caribbean to reduce or eliminate this mosquito where it transmits malaria.". Medical entomologist Willem Takken of Wageningen University in the Netherlands points out that while transgenic, Oxitec's mosquitoes are programmed not to have offspring, which makes it extremely unlikely that any newly introduced genes would spreadone of the major concerns of GM opponents. The Facebook post also included a video of Gates answering questions without context. Your membership is the foundation of our sustainability and resilience. Microsoft founder Bill Gates is pouring 3 million ($4 million) into a project to create killer mosquitoes that destroy each other through sex. Information provided by (Responsible Party): U.S. Army Medical Research and Development Command. This Facebook post takes videos of Bill Gates out of context and presents them as a truth bomb relating to debunked conspiracy theories. Image Via Muhammad Mahdi Karim/Public Domain. Participation in any study involving any investigational vaccine or drug within 30 days prior to the screening visit, or plan to participate in another investigational vaccine/drug research during or within 1 month following participation in this study. Version 13.0 (08May2015) 70 US Government Proprietary Deleted: 8 Deleted: 08JULY2014. Placebo immunization. This is a Phase 1 open-labeled study. Gates said the strongest analogy when speaking about GMOs was with medicines, where people also worry about side effects. About a year ago, genetically modified (GM) mosquitoes were released into the wildand they have been flying under the world's radar screen until last week. By signing up, you will receive newsletters and promotional content and agree to our. About a year ago, genetically modified (GM) mosquitoes were released into the wildand they have been flying under the world's radar screen until last week. On May 1, 2020, the U.S. Environmental Protection Agency (EPA) approved an experimental use permit to field test genetically modified mosquitoes but required that the company receive state and local approval before moving forward (read more about the docket and approval process). Female offspring that inherit OX5034 protein will die before reaching adulthood, leaving only the non-biting males to survive. "I don't think they did themselves a favor," says Bart Knols, a medical entomologist at the University of Amsterdam. Martin Enserink is a Deputy News Editor at Science. Snopes readers asked our team to dig deeper into the project and its rumored funding. Agree to refrain from blood donation (except as required in this study) for 3 years following P falciparum challenge. In good general health with no clinically significant health problems as established by medical history, physical exam and laboratory screening. Bill Gates-Funded Firm Released 150,000 Genetically Modified Mosquitoes In The Wild. All quotes delayed a minimum of 15 minutes. Another #BillGates project What could go wrong? U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. According to an analysis by AGRA Watch, a Seattle-based organization working for global food sovereignty, all but one of the signers of the support letter has received funds from the Gates Foundation. Compare serum read-outs between protected and nonprotected subjects and between immunized and mock-immunized subjects. Some are questioning why the company stayed mum for so long, calling it a strategic mistake that provides critics of genetic modification with fresh ammunition. Justice This arm will receive the first 3 immunizations of Cohort 2. eCollection 2020. says Gurmit Singh, chair of the Centre for Environment, Technology and Development in Malaysia, where Oxitec hopes to start a field trial soon as well. They were edited from a broadcast by the pan-European media network Euractiv from 2015, which showed Gates and his wife Melinda speaking in Brussels about their endorsement of genetically modified organism (GMO) crops (here). doi: 10.1371/journal.pone.0233840. Under the project, thousands of A. aegypti were altered to make their reproduction more difficult, thus slowing and eventually preventing the spread of mosquito-borne illnesses like Zika, and dengue fever. Oxitec has received $5 million from the Gates program, but the Grand Cayman trial is not part of that. GMOs are grown and sold under different regulations in the US (here), the EU (here) and the UK (here). A Bill and Melinda Gates-funded biotech firm has released thousands of genetically modified mosquitoes in the United States. A representative for the Gates Foundation said the claim that the video showed a genetically modified mosquito with a number or barcode stamped on it The target dose is dependent on protection results in cohort 1. While A. aegypti do not themselves carry malaria, the research conducted by Oxitec is said to inform future endeavors to genetically alter Anopheles. Read our, ClinicalTrials.gov Identifier: NCT01994525, Interventional Read more about our work to fact-check social media posts www.reuters.com/fact-check/about . In 2015, nearly 212 million people were infected and roughly 429,000 died, according to the World Health Organization. The work includes extensive dialogues with citizen groups, regulators, academics and farmers. His reference to injecting genetically modified organisms was shared without context, so it misleadingly appeared Gates was discussing the use of GMOs in vaccines for children. The project, one of Gates's Grand Challenges in Global Health, would "never" release GM mosquitoes the way Oxitec has now done in Grand Cayman, says James. PLoS One. Use of systemic immunosuppressant pharmacotherapy for greater than 10 days within 60 days of scheduled first immunization (inhaled and topical steroids are allowed; short duration or tapered corticosteroid regimens of 10 days or less that have been discontinued prior to first immunization are allowed). AAAS is a partner of HINARI, AGORA, OARE, CHORUS, CLOCKSS, CrossRef and COUNTER. This should help limit the transmission of malaria. All rights reserved. "It's a difficult situation," he says. "If these mosquitoes are completely safe, then why the hush-hush?" The A. aegypti mosquito is just 4% of the entire mosquito population in the Florida Keys, but is responsible for nearly all of the mosquito-borne disease transmitted to humans. Plan for surgery between enrollment and day 28 post-challenge (minor procedures, elective corrective vision surgery, and dental procedures are allowed). Choosing to participate in a study is an important personal decision. The Gates Foundation has given $2 billion worth of grants over the past two decades to fight malaria, according to Business Insider. Scientists have long debated how and when to carry out the first test release of transgenic mosquitoes designed to fight human diseasea landmark study they imagined might trigger fierce resistance from opponents of genetic engineering. Subscribe to News from Science for full access to breaking news and analysis on research and science policy. Following true-immunization or mock-immunization, study subjects and nonimmunized infectivity controls will receive a challenge via the bites of 5 An stephensi mosquitoes carrying infectious P falciparum sporozoites within a controlled clinical environment (controlled human malaria infection, CHMI) to determine the level of sterile protection. IMRAS-A clinical trial of mosquito-bite immunization with live, radiation-attenuated P. falciparum sporozoites: Impact of immunization parameters on protective efficacy and generation of a repository of immunologic reagents. Challenge occurs at the same time as Cohort 2 (3-20 weeks after the final immunization). Dubbed the FKMCD-OXITEC Mosquito Project, the investigational agreement in Florida was approved by the Florida Keys Mosquito Control District Board of Commissioners along with seven State of Florida agencies. doi: 10.1371/journal.ppat.1010282. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Researchers have been exploring this concept for more than a decade. Eventually, the presence of these genes will decline and be bred out in a short amount of time given A. aegypti lives between eight and 10 days and this is a short-term trial. "Vector control has played a critical role in reducing cases and deaths due to malaria over the past 15 years," said Philip Welkhoff, director of the malaria program at the Bill and Melinda Gates Foundation, in the release. Their offspring will carry the self-limiting gene, and the female mosquitoes -- only females bite -- will die before they become capable of biting people. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Oxitec announced a partnership with the Bill & ", Luke Alphey, chief scientific officer of Oxitec, says he "completely rejects" the notion that there was anything secretive about the trial, which was well-known within the island's population of 50,000, he says, "but just not picked up internationally.". Radiation-attenuated Plasmodium falciparum sporozoites (PfRAS) administered by the bite of infected Anopheles stephensi mosquitoes. Information provided by (Responsible Party): This study is to assess the safety, tolerability, and biomarkers of protection in healthy malaria-nave adults, who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock-immunization). This material may not be reproduced without permission. The mosquitoes were also altered to carry an inert fluorescent marker called DsRed2-OX5034, which will help researchers identify the genetically modified mosquitoes in the wild. When the males mate with females of a natural population, there are no progenyand if the transgenic males mate more often than the natural ones, the mosquito population will dwindle or even collapse. Your tax-deductible contribution plays a critical role in sustaining this effort. Marrian Zhou is a Beijing-born Californian living in New York City. How much U.S. forest is old growth? But that lack of a public debate doesn't sit well with the collaborators in a big international project, in which Oxitec is a key member, to develop and test GM mosquitoes. However, Gatess comments were taken out of context. The CDC says use of genetically modified mosquitoes has been successful in parts of Brazil, the Cayman Islands, Panama and India at controlling a species of WebThe Bill & Melinda Gates Foundation has found the work so promising it has invested nearly $38 million into genetic strategies to stop mosquitoes from transmitting diseases like 2023 CNET, a Red Ventures company. "As a private company, they can push their own agenda," says James, even though this could possibly hurt the field as a whole. Flying Syringes is a phrase that is used to refer to a proposed project funded by Bill Gates to create genetically modified mosquitoes that inject vaccines into people when they bite them. This helps us to track our insects in the wild, explained Oxitec. In short, we found that the Bill and Melinda Gates Foundation did award grants to biotech company Oxitec for its work to develop a new strain of genetically modified mosquitoes nicknamed Friendly to help reduce the spread of malaria. Science and AAAS are working tirelessly to provide credible, evidence-based information on the latest scientific research and policy, with extensive free coverage of the pandemic. These gene-carrying males will then mate with females in the field, and since only their non-biting male offspring will survive, the expectation is that the self-limiting gene will be passed along again to future offspring. You have reached the maximum number of saved studies (100). A. aegypti is endemic to Africa but has spread across the sub-tropical and temperate regions around the planet. The target dose is 960 infectious bites. In response to this authorization, the agency received more than 31,000 public comments, most of which urged that the EPA not permit testing or delay it until more information was made available. However, the Bill and Melinda Gates Foundation did award grants that funded biotech company Oxitec's work to develop genetically modified mosquitoes that may help reduce the spread of malaria and other mosquito-borne diseases in certain locations around the world. Last month, comedian Russell Brand gave his YouTube followers a 17-minute lecture about Bill Gates' plot to take over the world's food supply and force-feed the developing world genetically engineered (GE) crops. All rights reserved. Study Details ; Tabular View; who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock Du Y, Hertoghs N, Duffy FJ, Carnes J, McDermott SM, Neal ML, Schwedhelm KV, McElrath MJ, De Rosa SC, Aitchison JD, Stuart KD. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? While Gates does move around in this particular video (here), other unofficial clips of the deposition found on YouTube show him sitting perfectly still here and here). On Tuesday, officials in the Florida Keys Mosquito Control District (FKMCD) gave final approval to release 750 million of the modified mosquitoes over a two-year The trials were designed to test whether such designer mosquitoes could be successfully used to fight wild mosquitoes that transmit diseases like dengue fever. She joined CNET as a staff reporter upon graduation from Columbia Journalism School. Help News from Science publish trustworthy, high-impact stories about research and the people who shape it. The World Health Organization (WHO) is drafting guidelines for the release of transgenic mosquitoes, a process that will take at least 3 more months, says Yeya Tour, manager of innovative vector control interventions at WHO. CLAIM: A video clip shows a genetically modified mosquito with a serial number on its body that has been released as part of an experiment funded by Bill Administered by the bite of noninfected Anopheles stephensi mosquitoes, Occurrence of solicited adverse events (AE) from administration of study immunization (PfRAS), Occurrence of unsolicited adverse events (AEs) from administration of immunization (PfRAS), Occurrence of laboratory AEs from administration of study immunization (PfRAS), Occurrence of serious adverse events (SAEs) from administration of immunization (PfRAS), Occurrence of signs and symptoms related to malaria infection starting 7 days post-Controlled Human Malaria Infection (CHMI) (these will not be recorded as adverse events because they are expected as a result of malaria infection), Development of parasitemia and time to parasitemia after malaria challenge. The target dose is dependent on protection results in cohort 1. (Clinical Trial), Phase 1 Trial With Challenge to Assess the Safety and Biomarkers of Protection in Malaria-nave Adults of Immunization Via Mosquito Bite With Radiation-Attenuated Plasmodium Falciparum Sporozoites (IMRAS), Placebo Comparator: Cohort 1: Noninfected, Placebo Comparator: Cohort 2: Noninfected, Experimental: Hyperimmunity PfRAS-infected, Naval Medical Research Center Clinical Trials Center (CTC), PfRAS infected Anopheles stephensi mosquitoes, Noninfected Anopheles stephensi mosquites, Solicited adverse events [TimeFrame:7 days], Unsolicited adverse events [TimeFrame:14 days], Laboratory adverse events [TimeFrame:7 days], Serious adverse events [TimeFrame:52 weeks], Signs and symptoms related to malaria infection [TimeFrame:7 days], Identify and validate immunological PBMC biomarkers [TimeFrame:52 weeks], Identify and validate immunological serum biomarkers [TimeFrame:52 weeks], Identify and validate whole blood immunological biomarkers [TimeFrame:52 weeks]. (The Bill & Melinda Gates Foundation provided $19.7 million for a project to develop and test GM mosquitoes, according to Science .) An abnormal electrocardiogram (ECG), defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block. Genetically modified male Aedes aegypti The trial abided by the rules of the territory's new biosafety bill that has yet to become law, Alphey says. His reference to injecting genetically modified organisms was shared without context, so it misleadingly appeared Gates was discussing the use of GMOs in vaccines WebA Bill Gates-funded biotech firm has released genetically modified mosquitoes in the Florida Keys to combat insect-borne diseases like dengue fever and Zika virus. This may include psychiatric disorders (such as personality disorders, anxiety disorders, or schizophrenia) or behavioral tendencies (including active alcohol or drug abuse) discovered during the screening process that in the opinion of the investigator would make compliance with the protocol difficult. This article was produced by the Reuters Fact Check team. Please remove one or more studies before adding more. 2023 American Association for the Advancement of Science. WebEPA OKs plan to release 2.4 million more genetically modified mosquitoes "Following Oxitec's 2021 release of 144,000 mosquitoes in the Florida Keys, the EPA approved an expanded plan that added sites in California." Receipt of immunoglobulin and/or any blood products within 90 days of scheduled leukapheresis or immunization. Dont yet have access? The EPA issued a 150-page response to those comments, explaining its decision to move forward. Females of childbearing potential must have a negative pregnancy test at screening and agree to not become pregnant or breastfeed for the duration of the study. Why Florida is releasing genetically modified mosquitoes a Bill Gates-backed biotechnology company based in Abingdon, Oxfordshire. Using mosquitoes to stop malaria? Update [June 29, 2021]: The claim rating of this article was updated from "True" to "Mixture" after receiving further clarification from Oxitec. Already two billion genetically modified Aedes Aegypti mosquitoes are expected to be released within the next two years. 2022 Feb 2;18(2):e1010282. The biotech firm Oxitec has Claim: The Bill and Melinda Gates Foundation provided funding to genetically modify \u2014 and release \u2014 mosquitoes in various locations, including Florida. A whopping 750 million genetically modified mosquitoes will be set free along the Florida Keys starting in 2021. Although there were no town hall meetings or public debates, MRCU sent information about the study to local newspapers. Who is Monica Bertagnolli, Bidens pick to lead NIH? PLoS One. The gene can be passed along for up to 10 generations. As of this writing, the project was still in Phase 1. Correction [June 4, 2021]: This article was updated to clarify the differences between Aedes aegypti and Anopheles mosquito species. Relying mostly on anti-GMO superstar Vandana Shiva, Brand unsurprisingly got just about everything wrong. Misleading. Social media users have shared misleading videos of Microsoft co-founder turned philanthropist Bill Gates. The Environmental Protection Agency (EPA) has just approved a plan to release millions of Bill Gates-funded genetically-modified mosquitos into parts of the US. Compare Peripheral Blood Mononuclear Cell(s) (PBMC) read-outs between protected and nonprotected subjects and between immunized and mock-immunized subjects. The initial Reddit post was a reaction to the Zika virus spread through the Americas, including Brazil, and a rise in suspected cases of microcephaly, which can signify abnormal brain development. She must be willing to use a reliable form of contraception during the study. The target dose is 960 noninfected bites. A third 14-month grant for nearly $1.3 million was awarded to the same company in March 2021 for agricultural development" related to food sustainability with cattle tick and is again unrelated to work in the U.S. Oxitec told Snopes that the above grants are related to malaria-carrying mosquitoes not found in the U.S. and another species of mosquito that carries dengue, yellow fever and zika. The Bill & Melinda Gates Foundation has partnered with Oxitec for the development of a new strain of genetically-modified mosquitoes that can help reduce the spread of malaria in America. In April 2021, it was announced that approximately 150,000 mosquitos would be released across six locations in Florida. doi: 10.1371/journal.pone.0256396. eCollection 2021. The Bill & Melinda Gates Foundation has also worked with Oxitec to develop something known as a gene drive a genetic modification meant to spread through A look through the Gates Foundation grant documents revealed that upwards of $5.8 million was allocated to Oxitec in June 2018 for malaria-related projects around the world over 43 months. 3 doses (immunizations) of approximately 200 infectious bites (200-400 bites total) from PfRAS-infected mosquitoes. MRCU also posted a promotional video about the project on YouTube, but the clip does not mention that the mosquitoes are transgenic. In that study, the size of the population at the 16-hectare test site dropped by 80%a "complete success," Alphey said at a meeting of the American Society of Tropical Medicine and Hygiene in Atlanta on 4 November. Official records of the case are available on the United States Department of Justice website (here). The self-limiting gene prevents offspring of our released male insect from surviving to adulthood, and a fluorescent marker gene produces a protein throughout the body of the insects, which glows when exposed to a specific color of light. Biotech company Oxitec is partnering with the Bill and Melinda Gates Foundation to create genetically engineered mosquitoes that will help combat the spread of malaria, Oxitec said in a release on Tuesday. Available and willing to participate for duration of study. 1995 - 2023 by Snopes Media Group Inc. Bill and Melinda Gates Foundation. 5 doses (immunizations) of approximately 200 infectious bites (200-400 bites total) from PfRAS-infected mosquitoes (true-immunization). See here for a complete list of exchanges and delays. Colombian officials halt research, seize animals at NIH-supported facility after alleged monkey mistreatment, Scientists in India protest move to drop Darwinian evolution from textbooks. Weight less than 110 pounds (this does not apply to infectivity controls as it is a weight cut-off for subjects undergoing leukapheresis procedure). Challenge occurs 3 weeks after final immunization. Placement of the first mosquito boxes in Florida was rolled out the week of April 26, 2021, across six statewide locations. 3 to 7 doses (immunizations) of approximately 200 infectious bites (200-400 bites total) from PfRAS-infected mosquitoes (true-immunization). Oxitec's method is to unleash genetically engineered male mosquitoes to mate with wild female mosquitoes, which might carry malaria. In June 2020, the Florida Department of Agriculture and Consumer Services followed through and granted experimental use permit OX5034 for testing in the state. Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin during the day 7 to 28 post-challenge period. Current significant medical condition (cardiovascular, hepatic, renal, pulmonary, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination (includes bleeding disorders).