Instant-Result, Non-Invasive, Science-Proven COVID-19 Test 'IGNORED' by FDA Over a Year!

Instant-Result, Non-Invasive, Science-Proven COVID-19 Test 'IGNORED' by FDA Over a Year!

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Colton Reiswitz started this petition

“Petition for the FDA to grant an Emergency Use Authorization (EUA) for Beyond Artificial Intelligence’s (BAI) instant-result, non-invasive COVID-19 testing system that the FDA has so far ignored for over a year.”

PLEASE WATCH THIS VIDEO PRESENTATION TO PRESIDENT BIDEN AND DR. FAUCI AND ALSO READ ABOUT BEYOND ARTIFICAL INTELLIGENCE’S (BAI) INSTANT-RESULT, NON-INVASIVE COVID-19 TEST SYSTEM. PLEASE SHARE BOTH WITH FRIENDS AND FAMILY AND THEN, PLEASE SIGN THE PETITION TO HELP US ENGAGE CONGRESS TO INVESTIGATE AND EXPEDITE THE FDA’S PROCESS TO GRANT BAI AN EMERGENCY USE AUTHORIZATION (EUA)… FOR WHICH BAI HAS BEEN WAITING MORE THAN A YEAR!

Here’s a video link showing the BAI team and explaining what’s happening. If it doesn’t open, copy and paste the link in your URL.

https://vimeo.com/BEYONDAI/COVID-19-TEST

https://vimeo.com/manage/videos/698754560

Website: www.BeyondAI.com

Our Beyond Artificial Intelligence (BAI) instant test system can provide everyone with something no other so-called “rapid” testing can. We can create SAFETY BUBBLES everywhere in the world you want to go. Schools, work, sporting events, grandma’s house or international travel. We can create normalcy in the midst of the current pandemic situation and the unfortunately predicted continuation of the pandemic still to come.

The BAI System has been scientifically, independently tested, and proven in three separate double-blind clinical studies, involving over 1,220 subjects in India and the Philippines to assess the speed and accuracy of the BAI System in detecting COVID-19 in human subjects, with 100% accuracy every time. We have also successfully tested ±2,000 informed-consent volunteers in 11 countries (U.S., UK, France, Italy, China, India, Philippines, Mexico, Argentina, Hong Kong, Singapore), but only those conducted in India and the Philippines were double-blind tests.

These overseas tests were specifically requested by the FDA Deputy Director, Brendan O'Leary, he requested that BAI should conduct tests both outside United States and hospitals. He wanted to see how our BAI test would perform while utilizing a diverse population and that our test could be taken anywhere and be accessible for everyone. 

The first study was a Double-Blind Clinical Test conducted on January 8, 2021, at the prestigious Asian Institute of Gastroenterology (AIG) in Hyderabad, India with 67 subjects. AIG is a member of the American Mayo Clinic Care Network.
 
The second study was a Double-Blind Clinical Test conducted on April 17, 2021, in the Philippines with 553 subjects. The third study was a Double Verification Clinical Test conducted on September 27, 2021, in the Philippines with 600 subjects.
 
In all three of the above studies, testing was conducted by recording a subject’s face and/or voice; the recorded data was then analyzed by the BAI System. The BAI System test results were then compared to test results obtained by using the standard PCR nasal or oral swab test, in which biological samples were collected and analyzed from the same study subjects tested using the BAI test. The PCR tests were utilized as a study control and confirmed that the clinical findings using the BAI system were 100% accurate every time.
 
The BAI Intelligence Instant-Result, Non-Invasive COVID-19 Test System will play a major role in providing almost immediate results.

 

BAI Intelligence Instant-Result COVID-19 Test Technology System
 
 
What is Beyond Artificial Intelligence (BAI)?
 

BAI Intelligence (BAI) is an advanced Artificial Intelligence (AI) technology company registered in Delaware and operating out of Los Angeles, California that has invented and developed a revolutionary mobile healthcare App intended to rapidly detect COVID-19 in people. The mobile App and the related AI system is called the BAI Intelligence Instant-Result COVID-19 Test Technology System (“BAI Instant COVID Detection System”).
 
How Does the BAI Instant COVID Detection System Work?
 
The BAI Instant COVID Detection System (also referred to below as the “BAI System”) works by collecting data from a user through BAI’s App from any device capable of capturing a video or sound recording of the human body and/or voice. The BAI System then analyzes the video or sound data using Artificial Intelligence (AI) and Machine Learning (ML) to evaluate measurable frequency emitted from the human body and/or voice to determine if the user is COVID-19 positive. The user’s frequency data is collected with the simple use of a smartphone, cell phone, laptop computer, desktop computer, camcorder, or other type of audio-visual (AV) device. The recording of the user can be done in any of following formats – an AV recording (sound and video) of the user, a video of the user without any sound recording, a sound recording of the user’s speech, or a video scan of the user’s iris. The video and/or audio data captured by the user’s device is then transmitted digitally over the internet to the BAI System from the user’s device or computer, or from a stationary location (such as a booth) set up by BAI to record and upload the data to the BAI System for analysis of the frequencies emitted by the user’s body. Once received in the BAI System, the data is converted to specific encrypted code symbols. These symbols visually represent the algorithm used by BAI to ascertain whether the frequency emitted by a user matches the frequency of a COVID-19 positive person. The BAI mainframe computer uses AI and ML to decode the symbols and convert them into an easily understandable language from which BAI can create a report of results for the user. These results become immediately available to the user through the BAI App within 30 seconds to 1 minute.
 
What is the BAI App’s Principle of Operation?

The BAI App’s principle of operation and modality are based upon frequencies emitted from the human body. A user’s particular frequency is analyzed by proprietary AI and ML methods to assess that user’s COVID status. The BAI System and App were developed by BAI utilizing principles and theories of quantum physics, biophoton emissions, signal transduction, and cell signaling communication systems in the body. BAI has discovered that COVID-19-positive subjects emit a specific frequency that the BAI system refers to as the “COVID-19 frequency.” As noted above, this frequency is recordable using a device capable of video and/or audio recording, such as a smartphone, cell phone, laptop computer, desktop computer, camcorder, etc. BAI’s research indicates that subjects who are COVID-19 negative do not emit the COVID-19 frequency. The BAI System and App contain highly confidential and proprietary business and trade secret information.

Is There an Immediate Public Health Need for the BAI Instant COVID Detection System?
 

Yes, there is most definitely an immediate public health need for the BAI Instant COVID Detection System. According to President Biden, there is an immediate and critical need to bring products like the BAI System to market so people can be accurately assured that they are either COVID-positive or COVID- free. The App is non-invasive, there is substantial available evidence that it is safe and effective, and can easily be used by consumers in the home and in public settings. The FDA has also stated that there is an urgent “public health need” for products that can accurately diagnose COVID-19 anywhere. Approval and distribution of the BAI COVID-19 App into commerce would provide a significant public health benefit to users of the App, to the people around them, and to the public at large.
 
Has the BAI Instant COVID Detection System Been Proven to Rapidly and Accurately Detect COVID-19 in People?
 
Yes. BAI has conducted three (3) separate double-blind clinical studies involving over 1,220 subjects in two countries in order to assess the speed and accuracy of the BAI System in detecting COVID-19 in human subjects. In all of the studies, the results showed 100% accuracy in detecting COVID-19 in the human subjects.
 
The first study was a Double-Blind Clinical Test conducted on January 8, 2021, at the prestigious Asian Institute of Gastroenterology in Hyderabad, India with 67 subjects. The second study was a Double-Blind Clinical Test conducted on April 17, 2021, in the Philippines with 553 subjects. The third study was a Double Verification Clinical Test conducted on September 27, 2021, in the Philippines with 600 subjects. 
 
In all three of the above studies, testing was conducted by recording a subject’s face or voice, and then the recording data was analyzed by the BAI System. The BAI System test results were then compared to test results obtained by using the standard PCR nasal swab test, in which biological samples were collected and analyzed from the same study subjects tested using the BAI System. The PCR tests were utilized as a study control and confirmed that the clinical findings using the BAI system were 100% accurate. It is significant to note that the gold standard biological PCR test has an accuracy rate of less than 100% (i.e., ±97%). Accordingly, the BAI System has been shown to exceed the accuracy of the PCR test for COVID-19.
 
Given the time frame (January to September 2021) and geographical locations in which the above studies were conducted, and the fact that a number of variants were emerging and being identified globally, an inference can be drawn that the BAI System is accurate in determining the COVID status of a person even where that person may have a variant of COVID-19, and it certainly is at least as effective as PCR testing in determining the COVID-19 status of people who may have a variant.
 
Finally, there have never been any adverse events or side effects associated with use of the BAI System, and none were reported during the three studies.
   
Are There Any Risks Associated with the BAI App?
 

No. The risk of a false positive is nearly non-existent. Even if a result is a false positive, the risk can be countered by a repeat test, including PCR. Any additional masking or social distancing inspired by the test result are precautions already recommended for healthy individuals. The risk of false negatives is likewise low to non-existent and are further reduced by reminders to engage in the recommendations by the CDC and to contact the user’s personal physician to further evaluate the symptoms. As to the BAI App itself, it is non-invasive.
 
What is Immediately Needed to get BAI’s Instant COVID Detection System to Consumers in the U.S.?
 
FDA’s authorization on an emergency use basis is immediately needed to get the BAI Intelligence Instant- Result COVID-19 Test Technology System to consumers in the U.S. The App itself is currently being evaluated by FDA under its Emergency Use Authorization (EUA) program, and BAI responded to FDA’s request for additional information in support of EUA approval on March 31, 2021. BAI hopes to expedite FDA’s review as the Agency’s priorities have unfortunately shifted and do not seem to align exactly with President Biden’s priorities in terms of bringing rapid COVID-19 self-testing to market. Once FDA has authorized the test, it could be rolled out immediately and in the hands of millions of Americans within hours through a simple download of the App.

 

BAI’s Latest Attempt to Get an EUA Response from the FDA

Dear CDRH,

We are following up on the matter of Beyond AI (BAI), RE: PEUA210232. When COVID-19 first was declared a pandemic, we successfully developed a rapid test to detect this fatal disease. BAI submitted an Emergency Use Authorization (EUA) for a SARS-CoV (COVID-19) test on March 3, 2021. We followed up with FDA shortly thereafter. When we received a question to provide information about the technological characteristics on March 14, 2021, we responded with that information rapidly, on March 30, 2021. When no response was forthcoming, we sent a meeting request on September 13, 2021. We followed up on this request on September 20, 2021. As COVID spreads and mutates, we continue to test and gather evidence of the success of the device we designed and created. However, BAI’s test is still not available in the United States and FDA has yet to acknowledge our submission, our updates, our meeting requests, or our mounting evidence of safety and efficacy.

For almost nine months, we have received no response to our follow-up information, or to the meeting requests. CDRH staff seems unwilling to exercise its authority to review a EUA for another non-traditional test to diagnose COVID-19. We have been further advised that screening tests are no longer being reviewed under the EUA process at all. This directly contradicts the public guarantee made by Center Director Jeff Shuren on March 19, 2021, a date after BAI responded to the request for additional information and while we waited in vain for an FDA response. Dr. Shuren expressly committed to “continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools.”

Moreover, in making this announcement of support, CDRH described the data it relied on for the first EUA: A hospital study, which was considered a validation study, enrolled 467 asymptomatic individuals, including 69 confirmed positive cases, and demonstrated that the device had a positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6% and a negative percent agreement (proportion of the COVID-19 negative individuals identified correctly by the device to not possess certain biomarkers) of 94.5%. A school study, which was considered a confirmatory study, showed similar performance. BAI has conducted three (3) separate double-blind clinical studies involving over 1,220 subjects (over 2.6 times more), in two countries in order to assess the speed and accuracy of the BAI System in detecting COVID-19 in human subjects. In all of the studies, the results showed 100% accuracy in detecting COVID-19 in human subjects. We are prepared for, and welcome, additional testing for the marketing application. In the meantime, there is no basis to not grant our EUA due to study size or performance.

Dr. Shuren announced in November that “the FDA generally intends to focus its review on emergency use authorization (EUA) requests for the following types of tests: At-home and point-of- care (POC) diagnostic tests for use with or without a prescription and that can be manufactured in high volumes...” This test meets that criterion.

Our important technology has been languishing in FDA during the initial pandemic, and through the Delta and Omicron variants that have continued to fuel an upward spike since October 24, 2021. We have endured over 50.6 million cases in the US, and the deaths of almost 803,000 Americans, according to the CDCdata tracker on December 20, 2021.

Entire schools are closing because there is no ability for Americans to rapidly identify the infected and protect the uninfected. Education is falling behind. Travel and the employees in the industry are stymied. Jobs are terminated and employees who do come to work are at risk. Without this ability for workers to identify and protect workers, the economy, and Americans, we are suffering. Enjoyable, communal activities that might bring us together are fraught because actors, sportsmen, and women, entertainers cannot be masked or socially distanced while they work. “Mask fatigue” is increasing, and mask and vaccine resistance is dangerous. Commercially available tests are increasingly unavailable. The winter flu season is already upon us, and experts predict a deadly winter. We believe such an accelerated crisis is avoidable. A rapid, accurate test would protect all of us, and reduce the spread, and help minimize the risk of variants of the virus.

I began my basketball career under the tutelage of UCLA’s legendary coach John Wooden before I entered the NBA. As you may be aware, my connections today with the NBA run deep. In addition to my basketball career, I invented the TouchGlove, a United States-patented designed to allow athletes to improve their fingertip touch (shooting, dribbling, and overall ballhandling), including Hall of Fame player Jason Kidd and longtime NBA player and coach Greg Foster. Not even LeBron James, the world’s best basketball player, is immune from the false positives of currently available tests. His unnecessary quarantine after a false positive not only unnecessarily impacted his team and his fans but undoubtedly reduce public confidence in the tests that FDA has made currently available.

A test exists that will help solve this ongoing crisis. We need your help getting it to the American public. We can’t understand why FDA doesn’t seem to share or even acknowledge our solution for this urgency. We request that CDRH review this product right away. The FDA and HHS community should champion these tests as critical problem solves to the looming winter crisis and endless variants.

Thank you.

Andre McCarter

BAI Intelligence

 

Compare BAI’s Instant-Result, Non-Invasive COVID-19 Test System against all other At-Home COVID Tests… then choose…

Before we make those comparisons, let’s first consider what is an Unfair Advantage… in this case, BAI’s Unfair Advantage.

First, I Googled the definition of what an Unfair Advantage means in business:

"Do you know what your unfair advantage is? First, a definition: Your "unfair advantage" is the skill you have that is your unique talent. Were someone investing in you or in your idea, your unfair advantage might be why you'd win the investment over the competition." March 11, 2016

Wikipedia:

“An unfair competitive advantage, sometimes referred to as an exclusive competitive advantage or unique competitive advantage, provides a degree of certainty for eliminating competition; this is predominantly used in a business environment, however can also be applied in other ways too.

The main point to consider regarding an unfair competitive advantage is that the same opportunities are not available to everyone; unless the possessor of the unfair competitive advantage decides to grant permission for people to share the opportunity. While the origins of the term are unclear, the term is often used by marketing professionals.”
https://en.wikipedia.org/wiki/Unfair_competitive_advantage

Second, I Googled what would most people ask relating to, or concerning Unfair Advantage in business:

1. What is an example of an unfair advantage?

A real unfair advantage is something that cannot be easily copied or bought by your competitors. A great illustration of the difference between real unfair advantage from a weak one is the difference between organic SEO ranking versus paid keywords for search engine marketing."

2. How do you create unfair advantage?

Here are the 5 Pillars To Create An Unfair Advantage In Your Business:

1. Leadership. Ability to lead a team and develop other leaders. ...

2. Culture. Culture is the vibe and energy of your business. ...

3. Team Building. ...

4. Social Media. ...

5. Track Record."

Dec 10, 2018

Third, I Googled what are the latest and best articles on the web regarding what Unfair Advantage means in business:

STRATEGY Inc.: What's Your Unfair Advantage? Anything that is worth copying will be copied, so how do you establish an advantage? By building something that cannot easily be copied or bought.

https://www.inc.com/karl-and-bill/what-is-your-unfair-advantage.html

ENTREPRENEUR: 'Unfair Advantage': What's Yours and How Do You Capitalize on It? https://www.entrepreneur.com/article/269816

ASK LEANSTACK: What is an Unfair Advantage?

http://ask.leanstack.com/en/articles/904720-what-is-an-unfair-advantage

And now, here it is: Compare BAI’s Instant-Result, Non-Invasive COVID-19 Test System against all other At-Home COVID-19 Tests… then choose… and please note that BAI’s unfair advantage… will be of great benefit to you!

 

How Accurate Are At-Home Covid Tests? Here’s a Quick Guide

https://www.nytimes.com/article/at-home-covid-tests-accuracy.html

“When used correctly, many rapid antigen tests are good at detecting people carrying high levels of the virus.”

Compare against…

By contrast, using The BAI Instant-Result Non-Invasive COVID-19 Test System, one doesn’t need to be carrying high levels of the virus to work correctly.

The BAI System can easily identify the difference between the COVID-19 variants, Delta, or Omicron and either the common cold or flu.

"Americans can now take rapid antigen tests from the comfort of their own homes. Many of these tests are available without a prescription and return results in just 15 minutes."

Compare against…

Our BAI Instant-Result, Non-Invasive COVID-19 Test System produces 100% accurate results within ±30 seconds.

How accurate are rapid antigen tests?

"Some of the at-home rapid antigen tests have an overall sensitivity of roughly 85 percent, which means that they are catching roughly 85 percent of people who are infected with the virus and missing 15 percent. In some studies, their real-world performance has been even lower."

Compare against…

Our BAI Instant-Result, Non-Invasive COVID-19 Test System produces 100% accurate results within ±30 seconds. That’s because the BAI system has been independently, double-blind tested and scientifically proven three times, involving over 1,220 volunteer subjects in two countries to assess the speed and accuracy of the BAI System in detecting COVID-19 in human subjects. The tests showed 100% accuracy every time... thus, solving the world's biggest problem: the COVID-19 crisis.

When and how should I use them?

"Rapid at-home antigen tests are a good option for people who have been exposed to the virus, who want to know whether a sore throat is Covid-19 or just a cold, or who want a little bit of extra assurance before visiting a vulnerable relative or after traveling to a virus hot spot, experts said.

People with symptoms can take a rapid antigen test immediately, experts said, but those who have had a known exposure to the virus should wait three to five days before doing so. Testing too soon, before the virus has had a chance to replicate, increases the odds of a false negative.

“And that is a critical, critical piece,” Ms. Aspinall said. “There are a lot of people taking a plane, getting off the plane and saying, ‘I’m negative — I can go visit Grandma.’”

Some businesses, travel authorities and other organizations may not accept the results of at-home tests when proof of a negative test result is required, however."

I tested negative. Now what?

“Rapid antigen tests work best when they are used serially. If you test negative after a possible or known exposure to the virus, or after developing symptoms of Covid-19, you should take a second test a day or two later, experts said.”

“Tests are a moment in time,” Dr. Gronvall said. “You don’t know the day or the hour” that the virus “breached your immune defenses and took up residence.”

I tested positive. Now what?

“Rapid antigen tests are highly specific, which means that they generate relatively few false positives. However, a positive result is more likely to be a false positive when the prevalence of the virus is low; in these instances, people may want to take a second test. (The Centers for Disease Control and Prevention recommends lab-based molecular tests, like a P.C.R. test, for confirmatory testing.)

But experts recommended not waiting for the results of a second test to begin taking precautions. If you test positive, you should isolate yourself, monitor your symptoms and seek medical care if necessary.

Consumers should also report positive results to their local health authorities.

“If we don’t report tests accurately, we still won’t have a good idea of the actual caseload — how many people are running around that might be contagious, that might be passing this along to other folks,” Dr. Godbey said.”

Compare against…

It first needs to be understood that what BAI Instant-Result, Non-Invasive Technology COVID-19 Test System is offering cannot be defined as a product, as it is an intangible “service”—it’s a Mobile App!—The BAIsystem has no shortage of COVID-19 Tests… they are available without any limit! It’s the coolest and purest form of digital health safety… at your fingertips. That’s how simple, easy, convenient, user-friendly and, most importantly… safe, effective, and remarkably accurate the BAI system has been proven to be.

a. This is a system, based on very advanced facial recognition, that can instantly determine whether a person is positive or negative for the COVID-19 Corona virus.

b. There is no current FDA Emergency Use Authorization… that is what we are seeking and have been waiting since we submitted our answer to the FDA’s last question on March 30th, 2021.

c. Various testing techniques now exist, all with varying degrees of discomfort, eg: the PCR nasal or oral swab test and with varying wait times for the results. So, there is a critical need for a fast and reliable testing procedure… and that is precisely what BAI is offering. The test can be taken by anyone at anytime, anywhere in the world. All that is needed is to take a facial 10 second selfie video and send it to BAI at designated phone numbers. Within 30 seconds the person will know if he or she is positive or negative.

This innovative, instant-result, non-invasive, advanced facial recognition technology system has been tested on people in China, India, Germany, France, Hong Kong, Abu Dhabi, Philippines, England, Singapore, Argentina, Africa, and America, including a Presidential Support Specialist at the White House. The results were then compared with the invasive and uncomfortable PCR biological test results and proved to be remarkably accurate.

d. As it is non-invasive, it is completely safe.

e. There are no risks, only benefits, as described above.

f. There is no chemistry involved and there is no manufacturing.

g. Quantity is not a factor and, as the system is solely dependent on the individual’s use of a cell phone or camera, so, its use has no limits—no shortage of COVID-19 Testing for everyone or the world!!

This test system can be used to pre-screen everyone and thus enable various sectors of the economy to re-start… based on the certain knowledge of who is safe and who isn’t.

It is applicable to, for example: schools, universities and colleges, restaurants, churches, airports, cruise ships, film and tv production, concerts, all private sector companies, the government, the military, all sporting events, including the Olympic games. We can pre-screen entry to every building in the US… literally... everything and everyone!

Finally... and very importantly: you can share your BAI Instant-Result, Non-Invasive Covid-19 Test with anyone at a moment's notice. This means that before you meet with someone, you can both take the BAITest from your cell phones and then share the results with each other. If you're both negative, that gives you the peace of mind needed for a safe, face-to-face meeting.

 

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