Invest in Quadrant Biosciences: We develop novel, saliva based tests for Autism, COVID-19 and Parkinson's.

What does your company do?

We develop epigenetic saliva biomarkers including the world's first saliva test for autism. We recently received FDA emergency use authorization for a COVID-19 saliva test, and are currently working on developing tests for Parkinson's disease, concussion, and Anorexia nervosa.

Where will your company be in 5 years?

Our goal is to have the Clarifi epigenetic diagnostic tests become the standard of care, positively impacting millions of people across the globe. We also want to be on the forefront of RNA analysis and continue to contribute to the fight against RNA viruses such as COVID-19.

Why did you choose this idea?

With respect to the COVID-19 testing, it chose us more than we chose it! Our expertise in saliva-based, RNA testing - as part of our mission to develop diagnostic tests for autism and other neurological conditions - serendipitously placed us in a position to help address this global pandemic. We are now involved in three COVID-19 projects!

Why is this a good idea, right now? What changed in the world? Why wasn't this done a few years ago?

The short answer is a global pandemic. Just nine months ago we were solely focused on the release of our new Clarifi ASD autism diagnostic test, and developing epigenetic saliva biomarkers for Parkinson's disease, concussion and other neurological disorders. Then the pandemic hit and we found ourselves in the unique position to leverage our understanding of RNA analysis to join the fight against the virus. Since March, we have been involved in three distinct, but complementary, approaches to COVID-19 testing: 1) individual testing using our FDA EUA authorized Clarifi COVID-19 Test Kit developed in partnership with SUNY Upstate Medical, 2) group pooled surveillance testing of colleges and schools, and 3) municipal wastewater monitoring.

How far along are you? What's your biggest obstacle?

We just commercially launched the first of these epigenetic tests, Clarifi ASD, in December 2019. Clarifi ASD is the world's first epigenetic diagnostic tool for autism spectrum disorder. Our COVID-19 diagnostic work consists of three mechanisms of testing: municipal wastewater surveillance, pooled surveillance testing of NYS college students, and an individual COVID-19 diagnostic saliva test that recently received FDA emergency use authorization (EUA). Our biggest obstacle is having sufficient resources to continue to work with our university partners to research, develop, and commercialize diagnostic tools to the market as quickly as we have to date.

Who are your competitors? Who is the biggest threat?

Though we believe we do not currently have any direct competitors for our Clarifi ASD product, we believe that a number of organizations are, or may be, working to develop human health and disease diagnostic and preventative mechanisms, and or other novel technologies that may be competitive with our technology. We have numerous capable competitors in the area of detection and diagnosis of COVID-19, many of which are further along and better funded than we are.

How will you make money?

By selling our epigenetic products commercially to pediatricians and clinicians; first in the United States and then globally; and by selling our COVID-19 diagnostic tools and services.

What are the biggest risks? If you fail, what would be the reason? What has to go right for you to succeed?

The following are only some of the risks associated with this offering. Please refer to our offering document which contains a comprehensive list of risk factors that could adversely affect our business and prospects. 1. We are an early stage revenue producing company and have incurred losses since our inception. We have recently begun to generate some significant revenues but there can be no assurance that we will continue to do so, or that we will not incur annual losses for the foreseeable future as we further expand our product offerings, and may never achieve or maintain annual profitability. Any valuation of the company at this stage is difficult to assess. 2. There is currently no public market for our Common Stock or our convertible notes, and a public market for our Common Stock or our convertible notes may never develop. 3. Even if any of our product candidates receives marketing clearance or approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. 4. We have limited experience with the manufacturing and delivery processes and systems needed for us to commercialize our products on a large scale. 5. If the company loses certain senior management and key personnel or are unable to attract and retain skilled employees when needed, it may not be able to operate successfully. For more risks, see the Offering Document.

What is your proudest accomplishment?

With a relatively small team of highly dedicated individuals, we were able to accelerate the transformation of what we believe is a revolutionary scientific finding into a viable commercial product accessible to the public - Clarifi ASD. More recently, post-COVID we quickly applied our experience in RNA detection and analysis to develop commercial products and services for the detection and analysis of COVID-19.

What do you understand that your competitors don't?

That we are the first company to develop an epigenetic saliva test for autism speaks volumes about the current approach being taken to identify biological markers for autism. Significant time and money has been spent by many in the pursuit of a genetic biomarker for autism, however to date it has failed to yield a biomarker with any practical utility. On the other hand, we believe our novel approach, developed in research labs at SUNY Upstate Medical University and Penn State College of Medicine, and backed by peer-reviewed research, provides accurate diagnostic biomarkers for autism, and appears to hold promise as well for other neurological conditions such as Parkinson's disease, concussion and Anorexia nervosa.

What do you need the most help with?

Achieving sufficient funding to permit us to remain liquid and to grow and advance our concurrent development and regulatory approval of our suite of epigenetic and COVID-19 diagnostics and services.

What would you do with the money you raise?

1. Use the money for working capital purposes. 2. Continue to grow and expand the development and regulatory approval of our epigenetic diagnostic tests and our COVID-19 diagnostics and services.

Tell me about how the company started?

How we got here - our “origin story” It began almost a decade ago in a cold ice rink in upstate New York. There, Quadrant Biosciences' founder and CEO Rich Uhlig, was watching a youth hockey game when his son suffered a severe concussion. Frustrated with the diagnosis and management of his son's concussion, he was determined to do something about it, and thus Quadrant Biosciences was born. In the process of developing and launching a technology to objectively test balance and cognitive function called ClearEdge, Rich moved the company to the SUNY Upstate Medical University in Syracuse to leverage its highly regarded concussion clinic and motion analysis lab. That move changed everything. It just so happened that our office was in the same building that housed the Neuroscience departments and molecular core facility -- and its director Dr. Frank Middleton. Rich learned that Frank, and his then grad student Steve Hicks, MD/Ph.D., had stumbled upon an exciting discovery that certain molecules in the saliva of children were different in kids with autism. Unfortunately, the funding had run out and the research was at risk of being shelved indefinitely. Recognizing the groundbreaking nature of their findings, we entered into a relationship with SUNY Upstate to support the research and work on turning this amazing discovery into a viable commercial product. Fast forward seven years and lots of research, development, peer-reviewed publications, and hard work, the Clarifi ASD test is now available to the public. Moreover, we have been able to leverage our expertise in RNA analysis to co-develop an FDA EUA authorized COVID-19 test with SUNY Upstate Medical University, as well as provide pooled surveillance testing and wastewater monitoring for COVID-19.

What does your product pipeline look like?

One of the most exciting things about our epigenetic approach to autism diagnoses is that it has proven to have similar diagnostic utility to many other neurological conditions. In fact, we have published peer-reviewed research papers on epigenetic tests for Parkinson's disease, mild traumatic brain injury (concussion), and Anorexia nervosa. Commercial development of the Parkinson's disease product is currently slated for Q3 2021. Our COVID-19 work as part of a consortium selected by NY State to perform wastewater testing for communities around NY is ongoing, and subject to supply chain availability of materials needed to conduct the tests, looks promising. Our partnership with SUNY Upstate in conducting pooled surveillance testing of students returning to school looks very promising - we are currently contracted to provide test materials and services in relation to the testing of 450,000 students. Our partnership with SUNY Upstate in developing a saliva test for COVID-19 in individuals has resulted in FDA emergency use authorization for this test in September, 2020.

How much capital have you raised to date?

As of August 2020, we have raised over $30 million from private investors who have recognized the value in how we intend to change the landscape of diagnostics in the future.

Why is a Test Like Clarifi™ ASD So Critical Today?

1) Autism Prevalence is increasing at a rapid rate The prevalence of Autism has increased from 1 in 150 in 2000, to 1 in 54 according to estimates from the CDC. There are several theories related to this rise in prevalence, but answers remain unknown. 2) Early diagnosis and intervention can change the trajectory of a child’s life Decades of scientific research continuously show that children make greater improvements when intervention is started early in development. With early intensive behavioral intervention, initiated in the second or third year of life, approximately 50% of children with autism become functionally indistinguishable from their peers by the time they get to first grade. However, in the absence of such early intervention, only about 2% achieve average educational and intellectual equivalency. 3) Children need to be diagnosed before they can begin intervention services. Unfortunately, many aren't being diagnosed until after age 4, even though autism can be diagnosed as early as 18 months. This is due to several reasons but chief among them is the relatively small number of specialists trained to administer behavioral-based diagnostic assessments. In fact, the wait time for a child to be evaluated by a specialist is up to 1.5 years in some areas of the U.S.! This means that children in the United States, and many other countries, are not receiving a timely diagnosis or access to critical services until well after the point where they are most effective. 4) There are other challenges with the current diagnostic process Before Clarifi ASD, there were no other accurate biological tests to aid in diagnosing autism. Diagnostics rely heavily on direct observation of a child's behavior by a trained clinician and parent report of behaviors in other settings, leading to a process that has approximately 69% inter-rater reliability. This means that sometimes, even with several hours of comprehensive evaluation, a traditional autism diagnosis is missed or incorrectly provided.

Can Clarifi play a role in reducing the societal costs associated with autism?

Although the costs associated with autism treatment and care are substantial, early diagnosis and intervention can help significantly reduce these costs. In fact, if interventional services are initiated earlier in life, annual cost savings in education are estimated to exceed $13 billion, and annual cost savings in medical and residential care approach $24 billion. These are the quantifiable cost saving benefits based on expenditures. The value of reduction in opportunity costs, indeed the benefit of opportunities open to patients and their families of early diagnosis and treatment are incalculable as is the potential improvement in quality of life.

Where is your office located?

We are strategically headquartered in the Institute for Human Performance on the SUNY Upstate Medical University campus to rapidly translate cutting edge scientific advancements into commercial products. Our business is co-located with the University Hospital’s: Neuroscience Department Molecular Analysis Core Facility Concussion Management Clinic Concussion Research and Motion Laboratory We also recently opened an office in San Antonio, Texas.

Is there a fee charged when I make an investment?

Please note that whether you invest using a credit card, a check, an electronic check, or a wire, Wefunder will charge a minimum $8 fee for handling and processing your payment.

1	Applied our expertise in RNA analysis to co-develop FDA authorized COVID-19 saliva test with SUNY.
2	Developed & commercialized world's first saliva based epigenetic test for autism spectrum disorder.
3	Sales from our new saliva COVID-19 tests have exceeded $6.5MM to date since September 2020.
4	We are working with NY State to test municipalities' wastewater for COVID-19.
5	Working with SUNY on pooled saliva surveillance of returning college students for COVID-19.
6	Development of Parkinson's disease, concussion, and Anorexia Nervosa, diagnostic tools in progress.
7	Our company is led by a former Chairman & CEO of Morgan Stanley Bank, Richard Uhlig.

1	Our business is subject to a number of risks and uncertainties, including those highlighted in the section titled “Risk Factors” in our Reg CF Offering Document. These risks include, but are not limited to, the following: Risks Related to the Company’s Business We are an early stage revenue producing company and have incurred losses since our inception. We expect to incur losses for the foreseeable future as we further expand our product offerings and may never achieve or maintain profitability. The company has a limited operating history, which makes it hard to evaluate its ability to generate revenue through operations. If the company loses certain senior management and key personnel or are unable to attract and retain skilled employees when needed, it may not be able to operate successfully. The company may face substantial competition from a number of known and unknown competitors as well as the risk that one or more of them may obtain patents covering technology critical to the company’s businesses. We rely on a limited number of suppliers or, in some cases, sole suppliers for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers. The company relies on certain major distributors, making it vulnerable to changes in the business and financial condition of, or demand for its services by, such distributors. The technology upon which the company relies for its operations may malfunction; company methodologies may produce unanticipated consequences. Our business and operations would suffer in the event of system failures. The company and its subsidiaries are subject to cyberattacks, security risks and risks of security breaches. We worked in concert with Admera Health, a licensed clinical laboratory located in South Plainfield, New Jersey, to design, develop and commercially run our epigenetic diagnostics. Any disruption in Admera Health’s operations could materially impact our ability to continue to offer and sell our epigenetic diagnostics tests, including but not limited to Clarifi ASD, which could significantly affect our business, financial condition, results of operations, and reputation. If we are unable to support demand for our existing and our future products, including ensuring that we have adequate capacity to meet increased demand, or we are unable to successfully manage the evolution of our bioinformatics platform, our business could suffer. The company has a convertible note that it is treating as debt. New product development involves a lengthy and complex process, and we may be unable to successfully commercialize any other products we may develop on a timely basis, or at all, and the development and commercialization of additional products may negatively affect the commercialization of existing products. Our existing collaborations are important to our business, and future licenses may also be important to us. If we are unable to maintain any of these collaborations, or if these arrangements are not successful, our business could be adversely affected. We have no experience manufacturing our products at commercial scale, and if we decide to establish our own manufacturing facility, we cannot assure you that we can manufacture our products in compliance with regulations at a cost or in quantities necessary to make them commercially viable. Even if any of our product candidates receives marketing clearance or approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
2	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.
3	Risks Related to Government Regulation We offer products that are subject to regulation as medical devices by the FDA. If we fail to comply with any applicable FDA regulatory requirements, it may have a substantially negative impact on our business, financial condition or results of operation. We plan to perform epigenetic diagnostic tests that could, at some point in the future, be regulated by the FDA as medical devices. If the FDA decides to actively regulate tests like those that we plan to offer, we may need to obtain FDA and/or other regulatory clearances or approvals, and comply with other regulatory requirements, which may delay, encumber or block us from commercializing these diagnostic tests. If we fail to meet any applicable requirements of CLIA or state clinical laboratory licensure laws, that failure could prohibit and/or restrict the commercial sale of our epigenetic testing diagnostic technologies and otherwise cause us to incur significant expense. We are subject to federal and state healthcare regulations and laws relating to anti-bribery and anti-corruption, and non-compliance with such laws could lead to significant penalties. A violation of privacy, security or data protection laws could have a material adverse effect on the company and the value of the shares. Government regulations and other legal requirements affecting our company are subject to change. Such change could have a material adverse effect on our business. Our employees, independent contractors, principal investigators, contract research organizations, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose us to liability and hurt our reputation. If we or our contract manufacturers or other third parties fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business. We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
4	Risks Related to Investment in the Shares Any valuation of the company at this stage is difficult to assess. There is no minimum amount set as a condition to closing this offering. Future fundraising may affect the rights of investors. The securities are equity securities and are subordinate to existing and future indebtedness of the company. The company may not be able to declare and pay dividends on the shares of Common Stock. The amended and restated certificate of incorporation and the subscription agreement have forum selection provisions that requires disputes be resolved in specific forums, regardless of convenience or cost to you, the investor. The holders of the majority of the outstanding shares of our capital stock may require other stockholders to participate in certain future events, including our sale or the sale of a significant amount of our assets. Investors in this offering may be subject to transfer restrictions. There is currently no public market for our Common Stock, and a public market for our Common Stock may never develop.
5	Risks Related to our Intellectual Property · If we are unable to adequately protect our proprietary technology and intellectual property, or if we infringe on the intellectual property of others, it could have a material adverse effect on our business. Though we currently do not solely own any issued patents or pending patent applications, our goal is to either solely or jointly with our partners receive patent protection. We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and ultimately unsuccessful. We rely on a licensing agreement with the Research Foundation for the State University of New York and the Pennsylvania State Research Foundation. We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property. We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property. We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses. If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
6

Director	Occupation	Joined
Ira Fedder	@
Gary Wade West	@
Mary Ann Tyszco	@
Andy Rock	@
Andy Rock	@
Richard Uhlig	CEO @ Quadrant Biosciences Inc.	2015
Richard Bongo	CFO @ Quadrant Biosciences, Inc.	2018
James Croke	Secretary and General Counsel @ Quadrant Biosciences, Inc.	2018

Officer	Title	Joined
David MacLean	Chief Marketing Officer	2015
Richard Uhlig	President CEO	2015
Syed Ameen	EVP Corporate Strategy	2019
Richard Bongo	CFO	2018
Benjamin Perry	President	2015
Bryan Greene	Chief Operating Officer	2015
James Croke	General Counsel	2018

Date	Amount	Security
08/2020	$992,091	Convertible Note
	$28,450	Custom
06/2020	$160,000	Loan
04/2020	$500,000	Loan
04/2020	$775,600	Loan
02/2020	$2,560,250	Priced Round
09/2019	$4,850,400	Priced Round
11/2018	$5,000,000	Loan
07/2018	$13,061,709	Priced Round
06/2018	$6,119,000	Priced Round

Invest in Quadrant Biosciences

We develop novel, saliva based tests for Autism, COVID-19 and Parkinson's.

Invest in Quadrant Biosciences

We develop novel, saliva based tests for Autism, COVID-19 and Parkinson's.

$70,313

Invest via a

Invest via a

Why you may want to invest in us...

Why investors us

we've raised $34,111,851 since our founding

Our team

In the news

Downloads

From Epigenetic Diagnostics to Comprehensive COVID-19 Testing. How Did We Get Here?

Leaders in the Development of Epigenetic Diagnostic Tools

Three Levels of Testing: A Comprehensive Approach to Assessing COVID-19

But, we are still very much an Epigenetics Diagnostic Company!

Investor Q&A

Financials

At a Glance

Risks

Details

The Board of Directors

Officers

Voting Power

Past Equity Fundraises

Outstanding Debts

Related Party Transactions

Use of Funds

Capital Structure

The Funding Portal

Form C Filing on EDGAR

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Lender	Issued	Amount	Oustanding	Interest	Maturity	Current?
VEP Biotech Ltd.	11/12/2018	$5,000,000	$5,000,000	5.0%	10/12/2023	Yes
PPP Loan	04/17/2020	$775,600	$755,600	1.0%	04/17/2025	Yes
PathFinder Bank	04/27/2020	$500,000	$500,000	5.625%	09/24/2020	Yes
SBA	06/09/2020	$160,000	$160,000	3.75%	06/30/2050	Yes

$50,000	15% towards marketing costs and legal and accounting fees; 3% towards Wefunder fees; remainder for general corporate purposes
$1,070,000	10% towards marketing costs and legal and accounting fees; 3% towards Wefunder fees; remainder for general corporate purposes

Invest via a

Why you may want to invest in us...

Why investors us

we've raised $34,111,851 since our founding

Our team

In the news

Downloads

From Epigenetic Diagnostics to Comprehensive COVID-19 Testing. How Did We Get Here?

Leaders in the Development of Epigenetic Diagnostic Tools

Three Levels of Testing: A Comprehensive Approach to Assessing COVID-19

But, we are still very much an Epigenetics Diagnostic Company!

Investor Q&A

Financials

At a Glance

Risks

Details

The Board of Directors

Officers

Voting Power

Past Equity Fundraises

Outstanding Debts

Related Party Transactions

Use of Funds

Capital Structure

The Funding Portal

Form C Filing on EDGAR

Ask a Question

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