|1||This will be the FIRST at-home COVID antigen test.|
|2||Identifies an active COVID infection in 9 minutes.|
|3||We have a working prototype, preliminary clinical data, and are officially in clinical trials.|
|4||Our Team! Our team consists of 2 Ph.D. scientist founders and 5 Active Advisers (all M.D., Ph.D.'s, or MBA).|
|5||Incubators- YCombinator Online StartUp School Su18, Su19, and Su20 and John Hopkins Su18.|
I am extremely excited to be involved with such a dynamic company. My father died of pneumonia in 2007. His infection was very hard to diagnose. In fact they never found the actual bacteria. So this company and its directives speak personally to me. I am excited at the prospect of being able to speed up the process of diagnosis. The scientists and doctors at Quorum X are top- notch and are bringing their years of experience to the multiple projects being born from this incredible group.
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, We realized that we could utilize the same 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 QXD-3 COVID NOW 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 QXD-3 COVID NOW test can detect an active COVID-19 infection (even if an individual is asymptomatic).
The at-home COVID NOW test kit comes with everything a person would need to complete the test in the comfort of their own home including the support of a 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. They will ‘know that they know’ if they have the infection. Being able to detect a live infection is crucial in preventing the spread of this deadly infection.
The number of COVID-19 cases continues to rise
As of August 2020, reports are showing roughly 50,000+ new COVID cases daily. Many people have returned to work, restaurants and retail stores are opening their doors again and school systems and colleges have resumed classes. Reports of COVID ‘hot spots’ and ‘clusters’ are making headlines almost daily.
*map and data courtesy of cdc.gov, COVID testing numbers as of August 23, 2020
The pandemic is far from over which only validates the need for a diagnostic test such as COVID NOW. 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 is the answer; it is able to detect an active infection, from the privacy of an individual’s home and in ONLY 9 minutes.
Testing backlog and delays in receiving results
QXD-3 COVID NOW at-home test
Quorum X Diagnostic’s COVID NOW test is a cost-efficient, simple to use diagnostic test that can be taken at-home, providing results in only 9 minutes.
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.
What makes the COVID NOW 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 15 minutes meaning that the sample does not have to be sent off to a lab.
Preliminary Data Is IN!
Our preliminary data shows the following after testing 39 patient samples:
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
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 COVID NOW 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 COVID NOW 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 –
Quorum X Diagnostics has financial statements ending December 31 2019. Our cash in hand is $4,000, as of May 2020. Over the three months prior, revenues averaged $0/month, cost of goods sold has averaged $0/month, and operational expenses have averaged $2,000/month.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this offering. Some of the information contained in this discussion and analysis, including information regarding the strategy and plans for our business, includes forward-looking statements that involve risks and uncertainties. You should review the "Risk Factors" section for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
We are building a rapid-take home test for COVID. It is a lateral flow test, "kinda" like a pregnancy test, but for COVID. It will identify COVID during the 2-12 day incubation period, BEFORE, or during the early onset of symptoms.
We want to have a line of take-home rapid diagnostics. Similar to the company Alere, a diagnostic company that made rapid take-home POC lateral flows. They were bought by Abbott for 5.3B.
Given the Company’s limited operating history, the Company cannot reliably estimate how much revenue it will receive in the future, if any.
Quorum X Diagnostics Inc. was incorporated in the State of Delaware in September 2017.
Since then, we have:
Historical Results of Operations
Our company was organized in September 2017 and has limited operations upon which prospective investors may base an evaluation of its performance.
Related Party Transaction
Refer to Question 26 of this Form C for disclosure of all related party transactions.
Liquidity & Capital Resources
To-date, the company has been financed with $35,200 in debt, $19,500 in convertibles, and $3,000 in SAFEs.
After the conclusion of this Offering, should we hit our minimum funding target, our projected runway is 4 months before we need to raise further capital.
We plan to use the proceeds as set forth in this Form C under "Use of Funds". We don’t have any other sources of capital in the immediate future.
We will likely require additional financing in excess of the proceeds from the Offering in order to perform operations over the lifetime of the Company. We plan to raise capital in 4 months. Except as otherwise described in this Form C, we do not have additional sources of capital other than the proceeds from the offering. Because of the complexities and uncertainties in establishing a new business strategy, it is not possible to adequately project whether the proceeds of this offering will be sufficient to enable us to implement our strategy. This complexity and uncertainty will be increased if less than the maximum amount of securities offered in this offering is sold. The Company intends to raise additional capital in the future from investors. Although capital may be available for early-stage companies, there is no guarantee that the Company will receive any investments from investors.
Runway & Short/Mid Term Expenses
Quorum X Diagnostics Inc. cash in hand is $4,000, as of May 2020. Over the last three months, revenues have averaged $0/month, cost of goods sold has averaged $0/month, and operational expenses have averaged $2,000/month, for an average burn rate of $2,000 per month. Our intent is to be profitable in 6 months. If needed, the founders of the Company can infuse capital to cover short-term expenses.
We officially halted working on are QXD-1 Fast Test for Pseudomonal Pneumonia Lateral Flow test on April 1, 2020 and started working on The QXD-3 COVID NOW test at-home lateral flow test for COVID-19.
Upon EUA approval which will be in about 4 months. We have a potential order of 20K tests, which at a wholesale price of $30 a test would be equal to $600,000.
We are still actively fundraising for angel investors and VC's outside of the Wefunder platform. Plus we are applying to a number of grants as well.
That we are unable to get the test appropriate sensitivity and specificity for EUA approval.
The Company may never receive a future equity financing or elect to convert the Securities upon such future financing. In addition, the Company may never undergo a liquidity event such as a sale of the Company or an IPO. If neither the conversion of the Securities nor a liquidity event occurs, the Purchasers could be left holding the Securities in perpetuity. The Securities have numerous transfer restrictions and will likely be highly illiquid, with no secondary market on which to sell them. The Securities are not equity interests, have no ownership rights, have no rights to the Company’s assets or profits and have no voting rights or ability to direct the Company or its actions.
Our future success depends on the efforts of a small management team. The loss of services of the members of the management team may have an adverse effect on the company. There can be no assurance that we will be successful in attracting and retaining other personnel we require to successfully grow our business.
The antibodies that we are using aren't stable enough to withstand high output manufacturing.
That we aren't able to achieve a high enough sensitivity due to variability with the mass populous completing their own nasal swabbing.
That FDA EUA does not approve the at-home COVID NOW test due to unforeseen or uncorrectable circumstances.
If there are any unforeseeable problems with the ability to patent this technology.
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