ASD lab tests & the cash waiting in the wings

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In the privacy of your own home…

Several lab tests are being developed that may offer a heads up to parents that their child may have an autism spectrum disorder. We just covered two of them on our most recent story on The Autism Channel World News:

But there’s a story behind the story that demonstrates one thing driving the research; the rich untapped market of a medical niche where there’s still a dearth of drugs and treatments “on label” for ASDs.

The “on-label/off-label” distinction is an important one for pharmaceutical manufacturers, because it determines if they may dispatch an army of reps to doctors’ offices and pitch the product for their on-the-spectrum patients. For an in-depth look at how this works in practice, see Huffington Post’s investigative piece on Risperdal

But drugs have to run a long, expensive gauntlet to get to market, and increasingly, as we play with the official diagnosis of autism, the primary disorder becomes an umbrella that pairs with a set of co-morbidities. It’s the co-morbidities, like epilepsy, gastro-intenstinal problems, and ADD/ADHD that drive what drugs get prescribed to alleviate some of the symptoms.

Tests, particularly those that use gene sequencing or RNA analysis, have a much easier path to market than prescription medication, and an immediate built-in clientele: parents willing to shell out their own cash for a heads up for the common worry that their children’s development are atypical.

The marketing and money behind the research

Enter Quadrant Biosciences. This well-funded startup has started teasing its Clarifi product in social media, building a list of parents and clinicians who want notice when its saliva-analysis test comes to market in “Late 2018.” (Quadrant Biosciences did not respond to our request for an interview.)

It’s full staff of marketers, funders and researchers not only has a proposed solution to: “Does my child have an ASD?” but to “Does my child have a concussion?” which shares the demographic of potential buyers who will fork over their own funds for a quick, though not necessarily totally accurate answer.

In the case of ASDs this could serve a valuable purpose as we are woefully short of diagnosticians as insurance companies become pickier about what constitutes a diagnosis. Prioritizing those who were tagged by a lab test could help us better assign who gets a professional diagnosis quickly.

Our TACWN video story highlighted two research studies that promise real-world results soon, and both of them have a “back-end” biosciences company waiting in the wings to fund commercial testing. SUNY’s is Quadrant, as we’ve noted. But for the Davis team, it is Axial Biotherapeutics though they may not be quite as far down the road as Quadrant, whose test promises a much higher hit-rate (upwards of 75%.)

It’s still too early to tell how accurate these tests may be with either company’s product. The UC Davis team acknowledges they need a lot more biomarkers to make the test relevant, and the SUNY group is still a ways from having a track record.