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SynapDx Raises $6M to Support Clinical Study on Autism Test

NEW YORK (GenomeWeb News) – SynapDx today announced the completion of a Series A1 financing round that brought in $6 million to support a clinical study in support of the company's test for autism spectrum disorders.

Funds from this round of financing came from North Bridge Venture Partners and General Catalyst Partners.

Southborough, Mass.-based SynapDx is developing a blood-based test that measures RNA expression to differentiate children who have a higher risk for ASDs from those who don't. Its test aims to identify children with ASD by the age of 36 months.

The clinical study, which is anticipated to start in the first quarter of 2013, will seek to verify the results of a study by Boston Children's Hospital researchers published last week that found a 55-gene signature may have use as a diagnostic tool. SynapDx exclusively licenses the technology behind its test from the hospital.

Specifically, SynapDx's study will investigate whether a genetic signal exists for children with autism versus children with developmental delay, SynapDx President and CEO Stanley Lapidus told GenomeWeb Daily News.

Enrollment of patients for the study at Boston Children's Hospital has begun, and in total the study will target about 600 patients across 15 sites, Lapidus said.

The underlying technology behind the test is RNA sequencing, though that may change when and if the test progresses to commercialization, depending on how technology evolves, Lapidus said. He declined to comment on a commercialization timeline for the test, which currently has no name but internally goes by SDx002.

A handful of firms offer or are developing ASD tests, including IntegraGen and Lineagen, which last week entered into a deal with the Center for Autism and Related Disorders.

SynapDx seeks to differentiate its test by improving specificity and thereby allowing for a more rapid diagnosis for a child with ASD.

"Our own view is that the most clinically useful tests would be tests that have high sensitivity, even with moderate specificity, in order to make sure that children who are on the spectrum move quickly to referral and evaluation at a developmental medicine center, get a diagnosis, and get on behavioral therapy as soon as possible," Lapidus said, adding that in a symptomatic population sensitivity has precedence over specificity.

Each year in the US, he said, referral sites, such as developmental centers, examine between 120,000 and 150,000 children in whom autism or other serious developmental delays are suspected. Additionally, about 450,000 children in pediatric settings fail screening tests such as the Social Communication Questionnaire.

Lapidus co-founded SynapDx in 2010 with $10 million in financing. Before that, he co-founded Helicos BioSciences, Cytyc, and Exact Sciences.

In addition to funding its clinical study, some of the $6 million from the financing will be used to hire additional personnel in 2013.

The firm also announced today that Robert Carpenter has joined its board. Carpenter is the president of healthcare investment shop Boston Medical Investors and is a former vice president at Genzyme, now a fully owned subsidiary of Sanofi. He also founded Integrated Genetics and GelTex Pharmaceuticals.

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