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.