Featured Startup Pitch: Backed by some prominent investors, SynapDx is developing a test for significantly earlier Autism detection in children
July 12, 2013
StartUp BeatTM/ BRK Media, LLC.
Company: SynapDx Corporation
Headquarters: Lexington, Massachusetts
Year Founded: 2010
Brief Company Description: SynapDx is developing a blood test designed to enable earlier detection of autism spectrum disorders (ASDs).
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By Stanley Lapidus, co-founder and president
SynapDx Corporation is developing a proprietary blood-based test to help doctors identify children with autism earlier than they do today.
While children can exhibit symptoms of autism spectrum disorders (ASDs) before 18 months, the current average age of diagnosis is 4.5 years—well after the age when behavioral therapies can begin. Today, the ASD diagnostic process is complex and time-consuming, but research indicates earlier diagnosis and intervention can significantly improve patient outcomes.
Our test works by measuring amounts of RNA copied from each of many different genes. Those RNA amounts are influenced by a person’s genes and the environment. For each gene, the amount of RNA copied determines how much protein is made. The RNA and resulting proteins dictate many functions in the body, including how the brain develops, affecting speech, behavioral, and social skill development.
While there is not one single gene that determines whether or not a child has ASD, researchers have found that children with autism have different amounts of certain RNA sequences. Measuring this unique pattern of RNA forms the basis of the SynapDx test.
The test result is an ASD risk score for a child to help doctors make faster and better referral decisions—leading to earlier diagnosis, which enables earlier intervention and may lead to improved outcomes and reduced costs.
I’ve spent much of my career identifying problems in medicine that are clinically important, but scientifically overlooked. In the late 1980s, I founded Cytyc Corporation (NASDAQ:CYTC) to develop new technology for cervical cancer screening.
In 1995, I then founded EXACT Sciences Corporation (NASDAQ: EXAS), where I focused on early detection of colorectal and other common cancers. After that, I co-founded Helicos BioSciences, where we developed the first DNA-sequencing instrument to operate by imaging individual DNA.
When considering my next focus, autism clearly struck me as an issue that was clinically important, but had historically been scientifically overlooked. Because autism was not mentioned in the Diagnostic and Statistical Manual of Mental Disorders (DSM) until 1980, very few research dollars or efforts were focused on it. In fact, despite advances in awareness and research, National Institutes of Health (NIH) funding for ASD research remains less than five percent of other less common disorders.
ASD diagnosis can be a lengthy, complicated and frustrating process for both families and clinicians. When coupled with the time required to complete a full evaluation, families endure significant costs and months to years of fear and uncertainty about their children’s futures. By reducing the time to diagnosis, some of this stress can be alleviated and behavioral therapies can begin earlier.
Our test will be ordered by a doctor, so we’ll be working with pediatricians and specialists to educate them about its intended use. We recently launched the largest, prospective multi-site study evaluating an ASD diagnostic test.
With 20 sites and 660 patients across the U.S. and Canada, the study is the first of its size to look at RNA as a tool for early assessment of ASD risk.
Several of the country’s leading centers for autism research and treatment have signed on to participate in the study, including Mount Sinai, Boston Children’s Hospital, Nationwide Children’s Hospital, UC Davis MIND Institute, Texas Children’s Hospital, and Vanderbilt University.
The CDC now estimates one in 88 children in the U.S.—and one in 54 boys—will be diagnosed with an ASD. With research indicating that earlier intervention can lead to improved outcomes, enabling earlier autism diagnosis continues to increase in importance.
The current market opportunity has also been validated by our investors’ interest and commitment.
In December, 2012, we received an additional $6 million in financing from North Bridge Venture Partners and General Catalyst Partners to support our clinical study. Since then, we’ve received additional investment from Laboratory Corporation of America Holdings (LabCorp) and the Kraft Group.
How SynapDx is Different
SynapDx is focused on developing a test that will identify the vast majority of children with ASD. Currently, no other test has the ability to help as many children. This is because most other tests are genetic, while ours is based on gene expression.
Genetic tests are good at identifying potentially causative genetic changes for a small number of children, which means they are important, but have limitations as tools prior to clinical diagnosis. We are focused on developing a highly sensitive test that provides an ASD risk score for a child to help doctors make quicker referral decisions.
We are an evidence-driven company and intend to launch the test commercially on the heels of our clinical study. As the study progresses, we will be finalizing our sales and distribution strategy. We have a number of important relationships with national partners and are in discussions with others that we believe will be highly relevant to market roll-out.
Our clinical study sites are currently enrolling patients. Click here for more information on our study. We are always seeking top-tier talent to join us across our company as we work to enable earlier diagnosis of ASDs.
SynapDx – www.synapdx.com
SynapDx Secures $15.4M in Funding Led by Google Ventures
Timothy HayJuly 22, 2013(c) 2013 Dow Jones & Company, Inc.
SynapDx Corp., which is in clinical trials with a potentially breakthrough diagnostic to predict the risk of autism among very young children, has turned to another powerful strategic investor– Google Ventures–in a $15.4 million funding round, the company said.
The company has already raised funding from Laboratory Corp. of America Holdings and Kraft Group LLC , owner of the New England Patriots , and has amassed more than $32 million altogether from investors, Chief Executive Stan Lapidus said.
The company does not disclose its valuation or the class of stock on offer in its various funding rounds, he said.
The new infusion of capital will help the company complete clinical trials of its blood diagnostic in 20 sites, including some of the top children’s hospitals in the country, Mr. Lapidus said.
Google Ventures led the funding, joined by newcomer Foundation Medical Partners and returning investors North Bridge Venture Partners and General Catalyst Partners , the Lexington, Mass.-based company said.
It will be Google ‘s expertise with big data even more than its financial support that will boost SynapDx , which is trying to change the game for autism diagnosis and treatment, Mr. Lapidus said.
“Examining the genetic component of autism is a big data problem,” he said. ” Google has capabilities in multi-variant math that underlies the field of genomics. Their math is cutting-edge, computationally intense and on the cloud.”
The company is seeking to use genetics testing to predict the risk of autism in children as young as two years old, a product that would be the first of its kind if successful.
Autism is today diagnosed by behavioral specialists, usually in children aged five or older. Predicting the risk at an earlier age means earlier intervention for the child that can have a tremendous impact on the condition, the company said.
The blood tests examine the ribonucleic acids, or RNA, that becomes visible when white blood cells in a blood sample are dissolved. The behavior of RNA can be linked to autism risk, the company says.
Cells in the human body contain tens of thousands of genes, each of which produces proteins that can be examined to predict how the genes will affect the behavior of the cell.
This, Mr. Lapidus said, is where big data enters the equation.
While Google often collaborates with portfolio companies, the nature of the partnership between the two companies has yet to be hammered out.
The company’s clinical trials are being conducted at Boston Children’s Hospital, Mt. Sinai, Vanderbilt University and more than a dozen other locations, with some participants as young as two years old, the company said.
Write to Timothy Hay at firstname.lastname@example.org
More With SynapDX
Autistic people have fought the inclusion of ABA in therapy for us since before Autism Speaks, and other non-Autistic-led autism organizations, started lobbying legislation to get it covered by insurances and Medicaid.
ABA is a myth originally sold to parents that it would keep their Autistic child out of an institution. Today, parents are told that with early intervention therapy their child will either be less Autistic or no longer Autistic by elementary school, and can be mainstreamed in typical education classes. ABA is very expensive to pay out of pocket. Essentially, Autism Speaks has justified the big price tag up front will offset the overall burden on resources for an Autistic’s lifetime. The recommendation for this therapy is 40 hours a week for children and toddlers.
The original study that showed the success rate of ABA to be at 50% has never been replicated. In fact, the study of ABA by United States Department of Defense was denounced as a failure. Not just once, but multiple times. Simply stated: ABA doesn’t work. In study after repeated study: ABA (conversion therapy) doesn’t work.
What more recent studies do show: Autistics who experienced ABA therapy are at high risk to develop PTSD and other lifelong trauma-related conditions. Historically, the autism organizations promoting ABA as a cure or solution have silenced Autistic advocates’ opposition. ABA is also known as gay conversion therapy.
The ‘cure’ for Autistics not born yet is the prevention of birth.
The ‘cure’ is a choice to terminate a pregnancy based on ‘autism risk.’ The cure is abortion. This is the same ‘cure’ society has for Down Syndrome.
This is eugenics 2021. Instead of killing Autistics and disabled children in gas chambers or ‘mercy killings’ like in Aktion T4, it’ll happen at the doctor’s office, quietly, one Autistic baby at a time. Different approaches yes, but still eugenics and the extinction of an entire minority group of people.
Fact: You can’t cure Autistics from being Autistic.
Fact: You can’t recover an Autistic from being Autistic.
Fact: You can groom an Autistic to mask and hide their traits. Somewhat. … however, this comes at the expense of the Autistic child, promotes Autistic Burnout (this should not be confused with typical burnout, Autistic Burnout can kill Autistics), and places the Autistic child at high risk for PTSD and other lifelong trauma-related conditions.
[Note: Autism is NOT a disease, but a neurodevelopmental difference and disability.]
Fact: Vaccines Do Not Cause Autism.