SynapDx – 2013 Fierce 15

Based: Lexington, MA
Founded: 2010
CEO: Stanley Lapidus

The Scoop: SynapDx is "developing laboratory diagnostic services for autism and neurodevelopmental disorders, with the initial goal of enabling earlier detection of autism spectrum disorders." The company is working with scientific collaborators at Children's Hospital/Harvard University and The George Washington University Medical Center, plus corporate partners such as Illumina ($ILMN).

What Makes It Fierce: SynapDx is pursuing something genuinely new with its autism blood test, which is designed to evaluate the measurement of RNA expression differences to properly diagnose children at risk for autism spectrum disorders. And the goal here is to beat the current standard of care.

"Autism is primarily diagnosed by clinical assessment," CEO Stanley Lapidus told FierceMedicalDevices. "The clinician makes the diagnosis based on observed behavior and interviews with the parents."

But that is a problem for both identifying autistic children and getting them treated early enough to make a difference, he said.

"The subjective judgment of the primary pediatrician is combined with parental or physician reluctance [to address the warning signs], which somehow conspires to be the primary reason that over 80% of children are diagnosed above the age of 3," Lapidus noted. (Early warning signs can include failing to make eye contact, not responding to his or her name, or playing with toys in strange, repetitive ways, according to the nonprofit group Autism Speaks.)

An earlier intervention and diagnosis is thought to boost the chance that therapy can succeed, so SynapDx's test could bring major changes to the field if it is successful. And we're getting closer to finding out whether it will be. In July, SynapDx nailed down $15.4 million in new funding to help advance a 660-patient study of its signature blood test, which began enrolling patients in April. Lapidus told FierceMedicalDevices recently that the "trial is well on its way."

"Parents have been very eager to have children enrolled in the study," Lapidus said. "The enrollment rate is very high in families approached. We hope that augurs well, assuming good test results, for future commercial prospects."

Another thing that helps the company stand out from the pack: It's attracted a powerful and influential investor base since its 2010 launch. Google Ventures led SynapDx's latest round, which also attracted Foundation Medical Partners, plus existing investors North Bridge Venture Partners and General Catalyst Partners. LabCorp has also invested $2 million in the company, The Kraft Group contributed an undisclosed amount at one point, and SynapDx raised another $6 million in a "Series A1" venture financing announced in December 2012. An initial $9.3 million Series A came through in May 2010, with other financing from an individual investor.

What To Look For: In the coming months, it will be all about results. And the company won't be seeking them just through its 660-patient trial. Earlier in 2013, SynapDx allied with Illumina to try to develop something enhanced in the autism diagnostic space. The idea is to join SynapDx's proprietary autism test with Illumina's gene-sequencing platform to develop other tools to help detect autism spectrum disorders. And they won't stop there. They plan to take a broader look at other neurodevelopment "opportunities," so expect more news in that space in the coming months.

For more:
Special Report: Device and diagnostics startups: 6 to watch - SynapDx
SynapDx, Illumina ally to develop autism diagnostic tools
SynapDx attracts $6M for large autism Dx study
SynapDx to commence autism Dx trials in early 2013

-- Mark Hollmer (email | Twitter)

SynapDx – 2013 Fierce 15