MANILA, Philippines – Filipino-founded biotech firm InterVenn Biosciences on Friday, July 22, launched its Philippine office. Though the company is headquartered in San Francisco, California, the team that developed and maintains the proprietary AI technology that speeds up certain research processes for the company is made up mostly of Filipinos residing in the Philippines, including one of its founders, AI and blockchain expert Aldo Carrascoso. The company has about 150 Filipinos working in the Philippines, majority of whom are software developers, and who make up half of the company. Through the help of the company's advanced AI platform, the company is able to help its global groups of researchers and scientists significantly reduce the time it takes for some processes such as analysis of samples from months to seconds. It's through this meaningful application of AI that the firm has been able to make strides in the field since its founding in 2017, as well as strides in funding.

Fox News Flash top headlines are here. Check out what's clicking on Foxnews.com. The United States Food and Drug Administration (FDA) wants the public to be aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests circulating in the United States, according to a recent press release. "Counterfeit COVID-19 tests are tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users will think they are the real, FDA-authorized test," the administration said. "The performance of these counterfeit tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests." The at home diagnostic kits are primarily antigen tests.

Rapid COVID-19 tests can generate false-negative results because they aren't that sensitive, according to a medical expert. Rapid COVID-19 tests, or antigen tests, appear positive if they detect a certain amount of coronavirus -- also known as viral load -- from a sample taken from a person's body, according to BuzzFeed News. Dr. Emily Landon, an infectious disease expert, said that the window when viral load is at its peak can vary from person to person and can range from three days to more than a week as people's systems clear the virus at their own pace. Due to this, it may either take some time for an infected person's result to turn positive or never appear positive if they miss this window or collect their test sample incorrectly, among other things, according to Landon, who is also an associate professor of medicine at the University of Chicago Medicine. "Rapid tests are definitely not like a pregnancy test where it's going to be positive as long as it's been a few weeks after someone missed a period. It's only going to pick it up when you're at peak infectiousness, and they're almost never false positive," the doctor explained.

Donald Trump and his former White House chief of staff Mark Meadows are peddling a new story about the ex-president's coronavirus infection. Their first story was that Trump didn't test positive until Oct. 1, 2020, two days after he debated Joe Biden. Then Meadows admitted in his new book, The Chief's Chief, that Trump actually tested positive on Sept. 26, three days before the debate. That admission was problematic, since Trump never informed Biden--or hundreds of other unwitting people who interacted closely with the maskless president in the intervening five days--about the test result. So now Trump and Meadows have concocted yet another story: The Sept. 26 result was a "false positive."

The'Outnumbered' panel reacts to Sunny Hostin and Ana Navarro being pulled from the set moments before the vice president was set to arrive Ana Navarro, one of two co-hosts who were pulled from ABC's "The View" live on air Friday due to positive COVID-19 tests, has since revealed the results that caused the chaos were false positives. Producers informed Navarro and Sunny Hostin in their earpieces halfway through Friday's broadcast that they would have to leave the Hot Topics table, leaving Joy Behar and Sara Haines to conduct the rest of the show on their own. The remaining hosts often struggled to kill time, at one point taking questions from the audience, but often not being able to hear the questions that were muffled by their masks. Friday's drama was even more pronounced considering Navarro and Hostin were pulled just as Vice President Kamala Harris was on her way to the studio for an in-person interview. Even though Harris made it to the building, producers explained her appearance would end up taking place remotely from a separate room out of precaution.

He's 11-years-old and, until he can receive his shots, Gronvall's been using at-home COVID-19 test kits in order to determine if his sniffles are more than allergies or a slight cold. The test swabs are longer than a Q-tip, but easier on the nasal cavity than a flu diagnostic or the original "brain swab" used to test for COVID since early in the pandemic. "There's often a lot of stuff coming out of their nose," Gronvall said of her kids, with a slight chuckle, when we talked recently. As an associate professor at the Johns Hopkins Bloomberg School of Public Health, Gronvall knows the importance of testing. "We can't all rely on everybody being extra scrupulous and paying attention to all of the COVID restrictions," she said.

Tests for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed within days of the release of the virus genome ([ 1 ][1]). Multiple countries have been successful at controlling SARS-CoV-2 transmission by investing in large-scale testing capacity ([ 2 ][2]). Most testing has focused on quantitative polymerase chain reaction (qPCR) assays, which are capable of detecting minute amounts of viral RNA. Although powerful, these molecular tools cannot be scaled to meet demands for more extensive public health testing. To combat COVID-19, the “one-size-fits-all” approach that has dominated and confused decision-making with regard to testing and the evaluation of tests is unsuitable: Diagnostics, screening, and surveillance serve different purposes, demand distinct strategies, and require separate approval mechanisms. By supporting the innovation, approval, manufacturing, and distribution of simpler and cheaper screening and surveillance tools, it will be possible to more effectively limit the spread of COVID-19 and respond to future pandemics. Many types of tests are available for COVID-19 for clinical and public health use (see the figure). Testing can be performed in a central laboratory, at the point of care (POC), or in the community at the workplace, school, or home. COVID-19 testing begins with specimen collection. For medical use, a nasopharyngeal swab collected by a health care professional has been used for detection of virus infections. Demands on testing throughput for COVID-19, however, have driven new collection approaches, including saliva and less invasive nasal swabs. COVID-19 tests include molecular tests such as qPCR, isothermal amplification, and CRISPR, as well as antigen tests that detect SARS-CoV-2 proteins directly. Although rapid antigen tests have lower analytical sensitivity (i.e., require greater amounts of virus material to turn positive) than qPCR-based tests, their ability to detect infectious individuals with culturable virus is as high as for qPCR ([ 3 ][3]). Specificity (i.e., correctly identifying those not infected with SARS-CoV-2) of antigen tests achieves comparable results to molecular tests ([ 4 ][4]). Diagnostic testing for COVID-19 focuses on accurately identifying patients who are infected with SARS-CoV-2 to establish the presence or absence of disease and is performed on symptomatic patients or asymptomatic individuals who are at high risk of infection. This type of testing requires assays that are highly sensitive, so as to not miss COVID-19 patients (false negatives), and specific, so as to not wrongly diagnose SARS-CoV-2–negative individuals as having COVID-19 (false positives). These tests are typically performed by centralized high-complexity laboratories with specialized equipment using qPCR assays, with results that can be reported within 12 to 48 hours. Major bottlenecks in testing, however, have led to turnaround times exceeding 5 to 10 days in some regions, making such tests useless to prevent transmission. POC diagnostic testing at medical facilities can be qPCR assays, isothermal amplification, or antigen-based ([ 4 ][4]). These POC tests often require instruments that run a limited number of tests and can return results in under an hour. The need for an instrument limits the number of tests that can be performed and where they can be used. However, newer antigen tests are becoming available that do not require instruments or skilled operators, potentially allowing for much more distributed POC testing. Surveillance testing of populations can be used both as a tool for understanding historical exposures and as a measure of ongoing community transmission. For the former, serological testing of individuals for the presence of SARS-CoV-2–specific antibodies is used to identify those previously infected. For the latter, surveillance testing can be an effective way to monitor real-time SARS-CoV-2 spread in communities. One promising method is wastewater surveillance, which has been used to assess community transmission of poliovirus ([ 5 ][5]) and has shown potential for COVID-19 ([ 6 ][6]). qPCR testing of wastewater is used to detect SARS-CoV-2, and frequency dynamics of viral genetic material indicate COVID-19 infections in a community. Surveillance can also be performed from swab or saliva samples taken directly from individuals, and, in populations with low COVID-19 prevalence, pooling can be used to increase capacity and lower cost. For surveillance testing, the goal is not identification of every case but rather the collection of data from representative samples that accurately measure prevalence and serve to inform public health policy and resource allocation. Because the focus is on extrapolations to the population and not the individual, tests with known deviations from 100% sensitivity and specificity are still appropriate when the variance can be statistically corrected ([ 7 ][7]). To be most effective, results should include reported qPCR cycle thresholds, which is an estimate of viral load ([ 7 ][7]), to model epidemic trajectory and allow for real-time evaluation of mitigation programs ([ 8 ][8]), including once vaccination programs have begun. Screening testing of asymptomatic individuals to detect people who are likely infectious has been critically underused yet is one of the most promising tools to combat the COVID-19 pandemic ([ 9 ][9]). Infection with SARS-CoV-2 does not lead to symptoms in ∼20 to 40% of cases, and symptomatic disease is preceded by a presymptomatic incubation period ([ 10 ][10]). However, asymptomatic and presymptomatic cases are key contributors to virus spread, complicating our ability to break transmission chains ([ 10 ][10]). Entry screening to detect infectious individuals before accessing facilities (e.g., nursing homes, restaurants, and airports), along with symptom screening and temperature checks, can be beneficial, particularly in high-risk facilities such as skilled nursing facilities. When used strategically, entry-screening measures can be effective at suppressing transmission. Entry screening requires testing that provides rapid results—ideally within 15 min—to be most effective. The required sensitivity and specificity of entry-screening tests are, like all tests, context dependent. Entry-screening tests for a nursing home, for example, must be highly sensitive because the consequences of bringing SARS-CoV-2 into a nursing home can be devastating. Such tests must also be highly specific because the consequences of grouping a false-positive person with COVID-19–positive individuals could be deadly. Conversely, because children have substantially reduced mortality from COVID-19, entry screening into schools might require greater compromise that balances resources and sensitivity to test as many individuals as possible with a need to minimize disruptive false positives. Key to use of tests for entrance screening is that a negative test alone should not be considered sufficient to enter—that should be based on satisfying other requirements, including masks and physical distancing. Conversely, a positive test should be sufficient to bar entry in most settings. Public health screening is potentially the most powerful form of COVID-19 testing, aimed at outbreak suppression through maximizing detection of infectious individuals. This type of screening entails frequent serial testing of large fractions of the population, through self-administered at-home rapid tests, or in the community at high-contact settings, such as schools and workplaces ([ 9 ][9]). Public health screening can achieve herd effects by stopping onward spread through detection of asymptomatic or presymptomatic cases (fig. S1). Notably, not every transmission chain needs to be severed to achieve herd effects. Mathematical models that incorporate relevant variation in viral loads and test accuracy suggest that with frequent testing of a large fraction of a population, a sufficient number of cases could be detected to create herd effects ([ 11 ][11]). For example, Slovakia undertook public health screening to address COVID-19 ([ 12 ][12]): During a 2-week period, ∼80% of the population was screened using rapid antigen tests. With 50,000 cases identified, combined with other public health measures, it reduced incidence by 82% within 2 weeks ([ 12 ][12]). An important feature of large-scale public health screening is that centrally controlled reporting and contact tracing programs are not essential to induce herd effects as they are for surveillance testing. In a robust public health screening program, sufficient numbers of people are routinely testing themselves, such that contact tracing is subsumed by the screening program ([ 11 ][11]). Similar to home pregnancy tests, screening tests should be easy to obtain and administer, fast, and cheap. Like diagnostic tests, these tests must produce very low false-positive rates. If a screening test does not achieve high-enough specificity (e.g., >99.9%), screening programs can be paired with secondary confirmatory testing. Unlike diagnostic tests, however, the sensitivity of screening tests should not be determined based on their ability to diagnose patients but rather by their ability to accurately identify people who are most at risk of transmitting SARS-CoV-2. Such individuals tend to have higher viral loads ([ 13 ][13]), which makes the virus easier to detect ([ 14 ][14]). A focus on identifying infectious people means that frequency and abundance of tests should be prioritized above achieving high analytical sensitivity ([ 11 ][11]). Indeed, loss in sensitivity of individual tests, within reason, can be compensated for by frequency of testing and wider dissemination of tests ([ 9 ][9]). In addition, public health messaging should ensure appropriate expectations of screening, particularly around sensitivity and specificity so that false negatives and false positives do not erode public trust. ![Figure][15] COVID-19 testing strategies Testing for SARS-CoV-2 can be for personal or population health. Collection can be from symptomatic or asymptomatic individuals, as well as from wastewater and swabs of surfaces. The tests may be performed in central laboratories, at the POC, or using rapid tests. Attributes of tests differ according to application. GRAPHIC: KELLIE HOLOSKI/ SCIENCE Tests for public health screening require rapid, decentralized solutions that can be scaled for frequent screening of large numbers of asymptomatic individuals. Lateral-flow antigen tests and upcoming paper-based synthetic biology and CRISPR-based assays fit these needs and could be scaled to tens of millions of daily tests ([ 9 ][9]). These tests are simple and cheap, can be self-administered, and do not require machines to run and return results. The Abbott BinaxNOW rapid antigen test, which recently received an Emergency Use Authorization (EUA) in the United States as a diagnostic device, also comes with a smartphone app, allowing self-reporting of COVID-19 status that could be used instead of centralized reporting by public health agencies. Critically, despite being shown to be highly effective at detecting infectious individuals ([ 14 ][14]), very few of these tests are currently approved for screening of asymptomatic individuals, substantially limiting their utility. If such tests were made available direct to consumer (priced to allow equitable access) or produced and provided free of charge by governments, individuals could obtain their COVID-19 status at their own choosing and without complex medical decisions. Testing is a central pillar of clinical and public health response to global health emergencies, including the COVID-19 pandemic. Nearly all testing modalities have a role, and the one-size-fits-all approach to testing by many Western countries has failed. Many lower- and middle-income countries—including Senegal, Vietnam, and Ghana—have fared far better in their COVID-19 response, often using strong testing programs. The focus on diagnostic tests and the use of preexisting authorization pathways focused on qPCR-based clinical diagnostics not only slows the development and deployment of new surveillance and screening tests but also confuses the picture of what metrics effective public health tools should achieve. Testing to diagnose a patient with COVID-19 is fundamentally different from testing a person to prevent onward transmission. Regulatory pathways should be modified to incorporate these differences so that public health and screening tests are appropriately evaluated. It is necessary to be innovative and produce, distribute, and continuously improve the tests that exist to save lives and gain control of the COVID-19 pandemic. [science.sciencemag.org/content/371/6525/126/suppl/DC1][16] 1. [↵][17]1. V. M. Corman et al ., Euro. Surveill. 25, 2000045 (2020). [OpenUrl][18][CrossRef][19][PubMed][20] 2. [↵][21]1. M. G. Baker et al ., N. Engl. J. Med. 383, e56 (2020). [OpenUrl][22][CrossRef][23][PubMed][24] 3. [↵][25]1. A. Pekosz et al ., medRxiv 10.1101/2020.10.02.20205708 (2020). 4. [↵][26]1. R. Weissleder et al ., Sci. Transl. Med. 12, abc1931 (2020). [OpenUrl][27][CrossRef][28] 5. [↵][29]1. H. Asghar et al ., J. Infect. Dis. 210, S294 (2014). [OpenUrl][30][CrossRef][31][PubMed][32] 6. [↵][33]1. A. Nemudryi et al ., Cell Rep. Med. 1, 100098 (2020). [OpenUrl][34][CrossRef][35][PubMed][36] 7. [↵][37]1. R. Kahn et al ., medRxiv 10.1101/2020.05.02.20088765 (2020). 8. [↵][38]1. J. A. Hay et al ., medRxiv 10.1101/2020.10.08.20204222 (2020). 9. [↵][39]1. M. J. Mina et al ., N. Engl. J. Med. 383, e120 (2020). [OpenUrl][40][PubMed][41] 10. [↵][42]1. X. He et al ., Nat. Med. 26, 672 (2020). [OpenUrl][43][CrossRef][44][PubMed][41] 11. [↵][45]1. D. B. Larremore et al ., Sci. Adv. 10.1126/sciadv.abd5393 (2020). 12. [↵][46]1. M. Pavelka et al ., “The effectiveness of population-wide, rapid antigen test based screening in reducing SARS-CoV-2 infection prevalence in Slovakia,” CMMID Repository, 11 November 2020; . 13. [↵][47]1. E. A. Meyerowitz et al ., Ann. Intern. Med. 10.7326/M20-5008 (2020). 14. [↵][48]1. V. M. Corman et al ., medRxiv 10.1101/2020.11.12.20230292 (2020). 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The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests for the virus that causes COVID-19. In a letter to stakeholders, the FDA said Tuesday that while antigen tests can be used for the rapid detection of SARS-CoV-2, false positive results can occur, especially if users don't follow the instructions. "The FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings and continues to monitor and evaluate these reports and other available information about device safety and performance," the letter said. A Boston-area infectious disease expert said the antigen tests are good for large scale screening, when used properly, but must be followed up with more accurate testing. "If you are testing a population at low risk, it's fine to do these tests for screening," said Dr. Daniel Kuritzkes, chief of the Division of Infectious Diseases at Brigham and Women's Hospital.

Our technology has advanced, our diagnostics have improved and our testing capability has advanced since the beginning of this pandemic, says Dr. Nicole Saphier, Fox News medical contributor. The Food and Drug Administration (FDA) warned about the possibility of false positives that can occur when using rapid antigen tests to detect coronavirus, particularly if the test is not used correctly. The regulatory agency said it has received reports of false-positive results occurring in nursing homes and other health care settings. The agency warned that reading the test results either before or after the specified time provided in the instructions can result in false-positive or false-negative results. It also referenced the antigen EUA conditions of authorization, which specifies that authorized laboratories are to follow the manufacturer's instructions for use regarding administering the test and reading the results.

Financially strapped airlines are pushing an idea intended to breathe new life into the travel industry: coronavirus tests that passengers can take before boarding a flight. Several airlines, including United, American, Hawaiian, JetBlue and Alaska, have announced plans to begin offering testing -- either kits mailed to a passenger's home or rapid tests taken at or near airports -- that would allow travelers to enter specific states and countries without having to quarantine. The tests will cost fliers $90 to $250, depending on the airline and the type of test. At Los Angeles International Airport, a design company has announced plans to convert cargo containers into a coronavirus testing facility with an on-site lab that can produce results in about two hours. On Thursday, Tampa International Airport began offering testing to all arriving and departing passengers on a walk-in basis. It's an idea that has gone global, with a trade group for the world's airlines calling on governments to create a testing standard for airline passengers as a way to fight the COVID-19 pandemic instead of using travel restrictions and mandatory quarantines.