COVID-19 has shone a bright light on the critical need for testing and diagnosing in our healthcare system.
As a nation grappling with more than 1 million (and counting) confirmed COVID-19 cases, we have come to understand the vast difference between suspecting you have an illness and knowing for sure.
But COVID-19 is not the only illness lacking proper testing. There are 65,000 new cases of autism in this country every year. More than 600,000 children a year experience developmental delays that could be related to autism. And like COVID-19, early diagnosis of autism followed by the proper treatment makes all the difference in the world.
When intensive behavioral intervention for autistic children begins in their second or third year, about 50% become functionally indistinguishable from their peers by first grade. In the absence of intervention, that number falls to about 2%. Unfortunately, children are diagnosed when they’re 5 years old (on average).
How Could the Medical Community Let This Happen?
Until now, doctors have lacked the tools and resources to detect autism early. For one, there is no biological test for autism. Specialists observe a child’s behavior to reach a diagnosis. It takes a lot of training. And there are too few specialists to handle this. The average wait time for specialists is 12 months. And it reaches 1.5 years in some parts of the U.S.
Quadrant Biosciences fixes this problem. It has created the world’s first government-approved saliva test for autism. The test has an 82% to 86% accuracy rate of indicating the likelihood of autism in children. It is legally available in every state (except New York, which has its own regulatory approval system). In just a few months’ time, Quadrant has introduced the test to 130 clinics.
And this is just the beginning.
A Nimble Startup
Quadrant is a small company – especially when compared with the big global pharmaceutical companies. It was founded in 2015. It employs 40 people. And it enlists the help of the research labs at SUNY Upstate Medical University and Penn State College of Medicine.
Yet, it has done something of enormous importance and potential impact that other companies could not.
It took an unconventional approach to detecting autism… and struck gold.
The vast majority of pharmaceutical companies have been trying and failing to identify genetic biomarkers. Quadrant discovered that certain molecules (biomarkers) in the saliva of children were different in kids with autism.
Quadrant used a machine-learning algorithm to test about 20,000 possible biomarkers in the saliva before arriving at the best-performing combination for its test. It would have taken thousands of years to do this without machine learning.
Its proprietary algorithm also uses a patient’s medical history along with demographic data. The result is highly accurate tests.
Game-Changing Technology Proves Highly Accurate, Wins Accolades
Quadrant has more than 1,100 patients aged 18 to 83 months old participating in its studies. In one study of 700 children, the company’s autism test was 86% accurate. In another test with a different mix of children displaying autistic to nonautistic tendencies, the test was 82% accurate.
This beats the current diagnosis gold standard – the Autism Diagnostic Observation Schedule. This standard assessment tool, which is based on clinical observation of behaviors and communication abilities, is accurate about 75% of the time.
There have been 18 peer-reviewed papers supporting Quadrant’s epigenetic biomarker technology for autism. They’ve been published in a variety of widely respected scientific journals, including JAMA Pediatrics, Frontiers in Genetics, Journal of Neurotrauma, Journal of Oral Microbiology, Journal of Experimental Neuroscience and Autism Research. The science is real… open to critical review… and well-documented.
The National Institutes of Health (which has funded some of its research) calls Quadrant’s technology “game changing.” Specialists in the field are just as supportive.
“A biological test… is invaluable,” explains Dr. Mark Barros of THINK Neurology for Kids. “For the first time in my career, I have biological data to support my clinical impressions and reduce clinical uncertainty.”
“A test that can separate children who have screened positive into high likelihood of autism or low likelihood of autism could help streamline waitlists and permit earlier diagnosis and enrollment in autism treatment,” says Dr. Daniel Coury, who is a professor of pediatrics and psychiatry in the College of Medicine at Ohio State University. That nicely sums up Quadrant’s main objective.
Already Approved for Use
In the U.S., there are two paths to approval. One is through the Food and Drug Administration. But if your product uses clinical labs, it needs the other kind of approval, called CLIA (Clinical Laboratory Improvement Amendments). Quadrant got CLIA approval last November. In the following five months, it’s already been used in 30 states.
The hard part is over. Putting a team together from scratch and creating an accurate saliva test took five years. That part is done. Now Quadrant is monetizing its incredible achievement.
Quadrant’s addressable market is huge. Testing children who exhibit autistic behavioral signs for the first time could generate $600 million in testing revenue a year. There would also be a certain amount of retesting, so this projection is on the very low end of what the market is worth.
Quadrant is directing its marketing primarily to parents and secondarily to clinicians. In terms of demographics, Quadrant is focusing its initial marketing push on 38 high-income metro areas with a high density of children 5 years old or younger. About 17 million parents have already actively engaged with its content online.
Quadrant charges a little under $1,000 for its test kit. For the parents in this initial marketing push, it’s a minor pain point. The vast majority of these parents are determined to find out what’s going on with their child. (Since the tests are very new, they’re not yet covered by insurance. That should come in time.)
Quadrant has a strong management team. Its founder, chairman and CEO is Richard Uhlig, the former chairman and CEO of Morgan Stanley Bank. He brings more than 30 years of business and high-level decision making to his position.
He also brings a fierce passion to offering badly needed solutions to brain-related medical conditions. It’s personal for him.
About a decade ago, in an ice rink in upstate New York, Richard witnessed his son suffer a concussion while playing in a hockey game. Nothing was easy after that. His frustration grew as he saw the poor way the medical system handled his son’s concussion. He thought he could do something to improve it. And seven years later, it’s clear that he has.
That’s because the company’s epigenetics and the microbiome technology can be applied to more than autism. It will be used to create solutions to a number of other neurological conditions, like early-stage Parkinson’s disease, mTBI (mild traumatic brain injury) or concussion, anorexia, and schizophrenia. They all command huge markets similar to the size of autism’s. And they are all currently in development.
So far, the studies have gone very well. The next product Quadrant plans to introduce to the public is its Parkinson’s disease test. It’s scheduled to become available sometime in the second half of 2021.
Richard has also made liberal use of his network to fill Quadrant’s board of directors and clinical advisory board with highly accomplished doctors, medical researchers and business executives. The company is brimming in smarts and hard-won experience.
And the startup’s future looks as promising as its present.
Not Your Typical Opportunity
Crowdfunders are not usually asked to fund the large-scale rollout of breakthrough medical tests.
That honor usually goes to deep-pocketed institutional investors. And they have to write checks of $50,000 to $100,000 for the privilege of investing.
But you can invest in Quadrant for just $300.
I’d be surprised if I saw this kind of investment opportunity again. The technology is well-defended thanks to 29 patent applications (for biomarker panels). The technical risks are negligible for autism and very reasonable for the diseases Quadrant will be addressing in the near future.
The marketing will take some work. But there’s not a single obstacle that really worries me here.
Because Quadrant has taken away a great deal of your risk, its valuation is $266 million. But it’s worth every penny. Quadrant took the “road less traveled” and now finds itself in a best-case scenario. It’s on its way to becoming a dominant force in neurological-related testing.
For once, you’re not on the outside looking in.
How to Invest
Quadrant is raising up to $1 million in this round of funding on Wefunder. You’ll need to sign up for an account there if you haven’t yet.
Once you’re signed in to Wefunder, head over to the Quadrant Biosciences page. Now enter the amount you want to invest and click the green “Invest” button on the right-hand side of the screen. The minimum on this deal is $300.
All early-stage investments are risky. While this one has substantial traction and a very reasonable valuation, you can still lose your investment. As always, don’t invest money you can’t afford to lose. You should expect to hold on to this investment for 10 years.