First at-home COVID antigen test with results in 9 minutes.

Quorum X Diagnostics (QXD), is a medical diagnostics startup that was founded in 2017 to produce an effective yet simple and fast diagnostic test for Pseudomonas pneumonia to be used in physicians’ offices and/or clinics. The idea is that the test would provide real-time results without having to send samples off to a lab. The waiting period for the results of lab tests can average three days. In the case of a patient that may have Pseudomonas pneumonia, waiting three days can prove detrimental.

After spending a year and a half developing the QXD-Fast test for Pseudomonas pneumonia into a working prototype, it was evident that the same proprietary technology could be applied to other commonly diagnosed infections including diagnostic tests for bronchitis, urinary tract infections (UTIs), and yeast infections.

In the Spring of 2020, in the wake of the COVID-19 pandemic, the scientific team quickly realized that the same unique proprietary technology could be used to develop an at-home diagnostic test for SARS-CoV-2 (COVID-19) that would provide real-time results in 9 minutes. They switched gears in an effort to work on developing the COVIDNOW test. This diagnostic test for COVID is set apart from other COVID tests due to the fact that it is an antigen test versus an antibody test. Simply put, this means the COVIDNOW test can detect an active COVID-19 infection (even if an individual is asymptomatic).

The at-home COVIDNOW antigen test kit comes with everything a person would need to complete the test in the comfort of their own home including direct connectivity to Physician 360, telemedicine service. They do not have to send samples to a lab. They do not have to wait for days for results from the lab. They do not have to worry about exposing others. 

The test kit also has an accompanying free mobile phone APP that utilizes AI technology. This provides a direct link to Physician 360, QXD's telemedicine partner. The AI technology used with the APP is able to verify test results, provide heat mapping, and contact tracing capabilities. In addition, results can be authenticated through the APP and documentation sent to respective employers, medical facilities, to use for travel needs, or any other entity that might require individuals to show proof that they are negative for COVID. 

After a person takes the easy, fully at-home COVIDNOW test, they will ‘know that they know’ if they have COVID-19. Being able to detect a live infection is crucial in preventing the spread of this deadly virus.

*To watch the recorded video of QXD's webinars, please click here:

https://www.youtube.com/channel/UChtpKW7cDpO0agUjlz0UtsA/

The number of COVID-19 cases continues to rise

As of October 1, 2020, Worldometer.com statistics are showing roughly 350,000+ new COVID cases daily worldwide. Many people have returned to work, restaurants and retail stores are opening their doors again and school systems and colleges have resumed classes. As restrictions are being lifted all around the world, reports of COVID ‘hot spots’ and ‘clusters’ are making headlines almost daily.

The University of Washington's, Institute for Health Metrics and Evaluation released data on October 6, 2020, in an article entitled, "COVID Could Kill 2,900 Daily by Dec. 30, Computer Model Says".  The computer model projects daily coronavirus-related deaths in the United States could rise sharply in the coming months, going from around 770 now to more than 1,100 daily by the end of October; 2,000 daily by the end of November; and 2,900 daily by the end of December.

The pandemic is far from over which only validates the need for a diagnostic test such as COVIDNOW. The ability to detect an active infection in a timely and efficient manner is the only way to help slow down the spread of COVID. 

Quorum X Diagnostics’ at-home antigen test, COVIDNOW is the answer; it is able to detect an active infection, from the privacy of an individual’s home and in ONLY 9 minutes. 

• Current COVID tests that are being used, the RT-PCR tests, can only be processed in the lab by personnel trained to use the PCR equipment making each test costly, $150-200 per test.
  
• Only within the last few months have asymptomatic individuals been able to get tested for COVID without a prescription or special permission.
• Medical facilities offering COVID tests for asymptomatic individuals are still limited.
• Individuals exhibiting symptoms of COVID-19 will continue to take precedence over asymptomatic individuals if the availability of tests becomes an issue (i.e. a ‘second wave’ of COVID, the combination of COVID, and upcoming regular flu season - the 'twindemic').
• Risk of exposure for individuals as well as staff at doctor’s offices, clinics, or hospitals. Testing wait times can be 2-6 hours long making social distancing sometimes impossible in small waiting rooms.
• COVID testing facilities are constantly having to monitor and re-stock Personal Protective Equipment (PPE) as well as all supplies necessary to conduct safe-testing methods (swabs, tubes, reagents for PCR testing, cleaning supplies, all items needed in exam rooms).
• Drive-thru testing sites are not cost-effective and require a lot of manpower in order to run them efficiently. Wait times for these sites vary but can be from 1 – 6 hours long.
• The elderly, people living in rural areas or hard-to-access areas (such as in the mountains) may not be able to drive, have a car or have anyone to take them to a facility or drive-thru site.
• For an individual to go to one of the testing facilities or drive-thru sites, they have to take time off of work.
• Asymptomatic individuals do not know they are infected and expose others simply because they do not know they have COVID or don’t realize they are exhibiting symptoms of COVID (i.e. thinking runny nose and slight cough is just from allergies).
• TEST RESULTS for RT_PCR tests take anywhere from 1-14 days depending on demand (i.e. holidays, areas hit by ‘hot spots’ or ‘clusters’, etc.)
• Currently, the only at-home COVID test kits are simply collection kits (either nasal or saliva samples). The kit may be sent to the home where the sample is collected at home but the sample then has to be sent off to a lab for processing of results. 
• Other rapid diagnostic tests for COVID-19 recently brought to the market are only authorized for use in medical care facilities or by a physician's office and have to be administered by a health care professional. This means a person will have to leave their home, take time off of work, make childcare arrangements (if they have children), and/or take themselves and their children to a place where they still have to wait in line and risk exposure to individuals that are positive for COVID-19. 

QXD's COVIDNOW at-home test

Quorum X Diagnostic’s COVIDNOW antigen test is a cost-efficient, simple-to-use diagnostic test that can be taken at home, providing results in only 9 minutes.

Here’s how:

• Order a COVIDNOW* kit online or buy a kit at a local drug store. If the kit was ordered, it will be shipped directly to the individual’s home. Open the contents of the kit and make sure that you have everything you need: the nasal swab, the soft sample tube, and the test stick (it looks similar to a pregnancy test). *for ages 18 and older
• Swab your nose with the nasal swab provided. Only one nostril needs to be swabbed. The swab only needs to be inserted about an inch. Twirl the swab around the inside of your nostril several times and remove.

Note: as a guide, place your thumb and forefinger over your nose just below the point you can feel bone, take your other hand and insert the swab not going past the point where your forefinger and thumb are resting.

• Take the swab and place it in the soft tube provided. The tube contains a reagent that is used as part of the testing process. Once the swab has been inserted, place your thumb and forefinger on the outside of the soft tube and press together; ‘squish’ or ‘mash’ the tube containing the swab several times.
• After you have ‘squished’ or ‘mashed’ the tube several times, remove the swab, and set it aside. Take the tube and pour the contents onto the test strip. Note: the contents in the tube may ‘drip’ out or pour slowly.
• Now, wait for at least 9 minutes. Setting a timer for 9 minutes is most helpful but not necessary as long as you wait for the full 9 minutes.
• After 9 minutes have passed there will either be one line indicating a POSITIVE test for COVID or two lines displayed indicating NEGATIVE for COVID. Take a picture of the testing stick with your mobile device.
• Using the free, telemedicine service app, upload the picture.  AI technology will assess the intensity of the test line.  This analysis will help reduce the possibility of false negatives.  The telemedicine service is available for support with either reading the results, confirming results, questions about COVID-19, or questions about what your results mean.
• Please note: the telemedicine app is not necessary for the completion of the COVID test. If you are not using the app, simply contact your local physician or primary healthcare provider.

What makes the COVIDNOW test work? What is an antigen?

An antigen is a general term for a protein that is located on the outside of a virus. If the virus is present in a person’s body, the antigen is present. The COVID NOW test will screen for these antigens as a way to identify active infection.

Quorum X Diagnostics is the first company to create an at-home lateral flow antigen diagnostic test that is tailored to detect CoV-2 infections during the 2 to 12-day incubation period BEFORE the onset of symptoms. It is not a test screening for IgG or IgM. In addition to being able to detect an active infection, there is another unique quality that sets this test apart from the rest; test results are visible in 9 minutes meaning that the sample does not have to be sent off to a lab.

Preliminary DATA complete and in the last stages of clinical trials!

Our preliminary data shows the following after testing 39 patient samples:

• 18 were PCR confirmed COVID positive patient samples
• 21 were COVID negative patient samples
• 18 samples out of 18 samples tested positive using our COVID NOW lateral flow prototypes which puts the test sensitivity at 100%
• Out of the negative patient samples, the COVID NOW lateral flow prototypes confirmed 20 out of 21 making the specificity at 95%.
• There were NO false-negative and only ONE false-positive.

OFF to market we go!

Determining the sample size in a pandemic:

Presently, we are seeing 50,000+cases PER DAY in the United States alone.

→ For each daily case reported, 10 people were identified through contact tracing.

→ 50,000 cases per day times 10 people identified equals 500,000 new people needing testing.

→ 500,000 cases per day times 30 days would equal 15 million people in one month.

If only 3% of those people bought the COVID NOW test that would equal 450,000 tests per month. Currently, Quorum X Diagnostics has the manufacturing capacity for 1 million tests per month.

Simple math: 450,000 tests x $37.50/per test = $16,900,000 a month (or ~$50,000,000 in a three-month period). And that’s not even including markets outside of the U.S.

A real-life example might look something like this:

Jane works at a bar that is about to re-open. Before re-opening, everyone at the bar goes through a series of COVID pre-checks (daily temperature monitoring, review of COVID symptoms, etc.) to ensure that they are safe in time for re-opening.

Jane’s best friend Sue calls Jane two days before the bar reopens with the unfortunate news that her roommate, Pat, has tested positive for COVID-19. Jane recalls that she was at Sue’s place about a week before having dinner with Pat and Sue. Jane calls her manager at the bar to let them know about Pat's positive COVID test.

As a result, the bar is forced to postpone reopening for at least three weeks. Jane and the remaining fifteen employees of the bar are asked to take a COVID test. It takes about three days before all employees are able to get tested. It takes another 7 – 10 days before the results come back. In the end, no one at the bar, including Jane, had a positive COVID test. BUT, the bar lost much-needed business by having to remain closed for an additional three weeks.

In this scenario alone, Pat tested positive for COVID meaning Sue, Jane, and Jane’s fifteen co-workers all needed COVID testing. Factor in 10 people for contact tracing and this one case of COVID resulted in the need for 170 COVID tests. Using the COVID NOW test with results in 15 minutes would have cleared Jane and her co-workers in time for the bar to open as scheduled. Simple math: 170 tests x $37.50 = $6,375.00

Go-to-market strategies:

• Direct to the consumer via the mail through purchases made online.
• Distribution in drugstores utilizing connections with QXD’s telemedicine service, Physician 360. (Physician 360 is located in 50 states, with access to 900+ drugstores that already house a Physician 360 kiosk. The COVIDNOW test would be sold through the kiosks already in place).
• Lastly, business-to-business sales (i.e. meatpacking facilities, government agencies, bars, restaurants, school systems/universities, and colleges).

Quorum X Diagnostics is just getting started!

The mission of Quorum X Diagnostics is to produce effective yet simple rapid diagnostic tests. In doing so, the lag time between samples being sent to the lab, and the waiting period to receive results is eliminated. This gives healthcare professionals the ability to make a more thorough diagnosis thereby creating a more targeted course of treatment. In effect, this saves patients and medical offices/clinics time and money by cutting down the cost of repeat visits, over-prescribing of broad-spectrum antibiotics, and other medications, as well as, being able to diagnosis a life-threatening infection (in the case of Pseudomonal pneumonia) in time for life-saving treatment.

The same mission is applicable to QXD’s efforts with the COVIDNOW test except now the diagnostic tests can be done from home without having to send a sample off to a lab and waiting for results. The only way to slow down the spread of this deadly infection is to ‘know that you know’ if you are infected so you can take the necessary precautions to prevent the spread of COVID. The COVIDNOW test does just that. It displays results in real-time and lets you know if you have an active infection even if you are asymptomatic.

Making an investment is a huge decision and one that we don’t take lightly. Rest assured that we are dedicated, determined, and passionate about what we are doing.

Know that –

• The COVIDNOW antigen test is unlike any COVID test on the market.
• QXD’s COVIDNOW test is an antigen test vs. an antibody test meaning it can detect active infection.
• The sensitivity of the COVIDNOW test is able to detect an active infection in asymptomatic individuals.
• The COVIDNOW test is an at-home COVID test with results in 9 minutes (not days or weeks) and available without a prescription.
• The sample from the COVIDNOW test does not have to be sent off to a lab.
• Everything needed to complete the test is included in the COVIDNOW test kit.
• QXD has partnered with Physician 360, a telemedicine service, to be the support component of the test kit after the results have been displayed.
• The QXD COVIDNOW at-home test kit has a mobile phone APP that using AI technology and works in conjunction with the telemedicine service but the kit is stand-alone and does not require the use of the app.
• QXD has already cultivated a partnership with Physician 360, the telemedicine service. Physician 360 currently has kiosks housed in 1,000+ stores across all 50 states.
• All patent applications required for the proprietary technology used to produce QXD’s rapid diagnostic tests have been submitted and are currently pending.
• Clinical trials are officially underway. Once the clinical data has been finalized, QXD will be able to submit its application for an Emergency Use Authorization (EUA) from the FDA for the COVIDNOW test kit.
• Should Quorum X Diagnostics not receive the EUA from the FDA, it still has the QXD-1 Fast Test for Pseudomonal pneumonia as well as other similar rapid diagnostics tests in the pipeline.
• QXD has a clear exit strategy. Within five years continue the development of the proprietary technology and to build out the scientific and organizational infrastructure of the business model at which point it would be optimal for a larger corporation to take the vision to the next level.
• QXD has an amazing team and we're the team to get it DONE!