When I received an invitation to a webinar titled “Special Session on a New Autism Risk Test,” I expected a discussion on screening strategies or intervention innovations. Instead, when I researched the company and reviewed its website, I discovered a pitch for a punch-biopsy-based lab test marketed as a way to detect autism risk in newborns as early as two days after birth.

As a nurse practitioner who treats autistic patients, and the mother of two autistic children, I am invested in this field personally and professionally. I believe in early detection. I believe in early intervention. But most of all, I believe in science. And what I saw in this presentation left me alarmed.

The company markets a test that analyzes calcium signaling in skin fibroblast cells. They claim this test detects “biological risk” for autism by assessing IP3R-mediated intracellular calcium release, using a technique adapted from basic science research.

Their foundational reference is a 2017 preclinical study which showed impaired calcium signaling in neurons derived from autistic individuals using induced pluripotent stem cells. However, that study did not use fibroblasts. It did not evaluate infants. And it did not validate a diagnostic test.

Despite this, the company asserts that their test can guide early intervention and cites potential IQ gains of up to 17 points. That figure comes from behavioral intervention research, including a randomized trial of the Early Start Denver Model (ESDM) that showed IQ gains of up to 17 points in toddlers, not from any study of this assay.

This is marketing dressed as medicine.

The test is a lab-developed test (LDT) offered through a partner laboratory in California. Like many LDTs, it has not been FDA-approved or cleared, as noted in the test’s own fine print. It’s also not covered by insurance. Parents pay out of pocket for a test that offers no actionable result, validated cutoff, or clinical guidance.

And while skin biopsies are low-risk, they are not risk-free. Performing an invasive procedure on a newborn without clinical necessity requires a high bar of justification, a bar this test does not meet.

The laboratory is not new to scrutiny. In 2021, the lab paid a $357,000 settlement for violating the False Claims Act, after allegedly billing Medicare for genetic tests without proper physician oversight. According to the U.S. Department of Justice, the lab partnered with marketers who recruited vulnerable seniors into unnecessary testing schemes. One such contractor was later convicted of health care fraud.

This is the same lab now offering parents insight into their child’s neurodevelopmental future based on a skin sample.

Would you trust this lab to shape one of the most emotional, consequential health care journeys a family may face?

If a parent receives a “positive” result, what then? No pediatrician should initiate services based on an unvalidated cellular biomarker. Autism diagnosis remains rooted in behavioral observation, milestone tracking, and multidisciplinary evaluation.

The result of this test doesn’t change clinical management; it only introduces ambiguity. For some families, it may trigger unnecessary anxiety. For others, false reassurance. Worst of all, it could delay referrals for evidence-based evaluation.

To be clear, I am not anti-innovation. Autism is complex, and we urgently need better tools for screening, support, and understanding. Calcium signaling as a research target is worth exploring. But that’s exactly what it is right now: research, not readiness.

It’s one thing to explore a promising cellular biomarker in the lab. It’s another to market it to sleep-deprived new parents eager for certainty.

We have an ethical obligation not to confuse hope with hype.

Autistic people deserve research grounded in rigor, not speculation. Families deserve tools that inform, not mislead. Clinicians deserve diagnostic innovations they can trust.

The future of autism care demands scientific rigor: replication, regulatory oversight, and real-world clinical validation, not branding, biopsies, and speculative biomarkers.

As a nurse practitioner, and a mother, I urge our clinical community: Don’t let pseudoscientific diagnostics into our exam rooms. Not now. Not like this.

Let’s hold the line for our patients, our families, and our profession.

Carrie Friedman is a dual board-certified psychiatric and family nurse practitioner and the founder of Brain Garden Psychiatry in California. She integrates evidence-based psychopharmacology with functional and integrative psychiatry, emphasizing root-cause approaches that connect neuro-nutrition and gut–brain science, metabolic psychiatry, immunology, endocrinology, and mind–body lifestyle medicine. Carrie’s clinical focus bridges conventional psychiatry with holistic strategies to support mental health through nutrition, physiology, and sustainable lifestyle interventions. Her professional writing explores topics such as functional medicine, autism, provider well-being, and medical ethics.