Ignite Biomedical and Liquid Biosciences Announce the Discovery of Biomarkers for the Diagnosis and Treatment of Autism Spectrum Disorder

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Biomarker discovery opens the way for development of novel transformational technology in Autism Spectrum Disorder.

FRAMINGHAM, MA / ACCESS Newswire / November 4, 2025 / Ignite Biomedical, Inc. ("Ignite"), a leader in AI-driven biomarker innovation for precision medicine, along with Liquid Biosciences ("Liquid"), today announced the discovery of biomarkers to diagnose and treat autism spectrum disorder ("ASD"). This achievement commences Ignite's expansion into drug development, while also maintaining their focus on diagnostic and treatment predictor tests in areas with tremendous unmet needs.

"We're incredibly excited about this milestone and what it means for Ignite and our potential to develop both life-changing diagnostics as well as therapeutics for the families that battle this difficult condition," said Claudio Faria, Chief Executive Officer of Ignite Biomedical. "This discovery highlights the power of Liquid's AI-driven platform to uncover meaningful biological insights that can transform how complex conditions like autism are diagnosed and treated."

Development of the ASD diagnostic assay has commenced, with the process of analytical validation now underway in collaboration with Calbiotech, Inc., the CDMO partner supporting assay development and validation. Following achievement of that milestone, the company plans to launch clinical studies to evaluate the test's accuracy in patients with ASD. The identified mRNA biomarkers have exhibited a high degree of accuracy, showcasing greater than 90% in both sensitivity and specificity in detecting the presence of ASD as well as the ability to detect distinct subtypes.

Liquid has also identified a separate core set of novel biomarkers directly connected to the underlying causal biology of ASD. This breakthrough discovery creates an opportunity for the development of transformational therapeutics to treat ASD which would address a tremendous unmet need. To date there are no FDA-approved drug products for the direct treatment of Autism.

"Neurodevelopmental disorders such as autism spectrum disorder are complex and heterogeneous making the identification of subsets of this disorder for prognosis or treatment difficult," said Dr. Richard Frye, MD, PhD, Director at the Autism Discovery & Research Foundation. "AI-discovered technology, such as Ignite's, has the promise to help us understand the complexity of autism from multimodal datasets to better understand this disorder and to better determine treatment plans to help children recover".

Early Diagnosis & Family Impact

Early detection, diagnosis, and treatment are the gold standard for any disease. In ASD specifically, early diagnosis can significantly improve outcomes for both children and families. Earlier access to appropriate support services, educational resources, and community programs, leads to better coping mechanisms, less parental stress, and enhanced adult independence. "Although ASD can be diagnosed by a specialist around age 2, the average age of diagnosis is closer to age 5. Our test has the potential to close that gap", said Stuart Gitlow, MD, MPH, MBA, and SVP of Clinical Development at Ignite Biomedical.

About Liquid Biosciences

Liquid Biosciences is the leader in quantitative AI for diagnostics and pharma. The company's Emerge quantitative AI platform agnostically discovers and models the nonlinear dynamics of biology, behavior, and circumstances that drive patient outcomes. Liquid Biosciences has completed over three hundred major analytic programs across sixty diseases, including the discovery of diagnostic and prognostic biomarker panels for more than twenty diseases.

For more information, visit http://www.liquidbiosciences.com

About Ignite Biomedical

Ignite Biomedical is at the forefront of AI-driven biomarker discovery and development for precision medicine. The company's flagship product, the TNFi TRP, is designed to identify patient responders and non-responders to TNFi therapy. Ignite's broader pipeline targets areas of unmet medical need, including immunology, behavioral health, and substance use disorders.

Our scientific and commercialization approach is designed to accurately discover and develop algorithmic biomarkers, which can be used to develop diagnostics, Treatment Response Predictors (TRPs), and potential drug targets. Across all FDA approved products, only 36% respond to therapy, leaving 64% of patients facing risk of side effects and financial burden with no clinical benefit. Treatment non-response accounts for over $1 Trillion annually in wasted healthcare spending. Our mission is to alleviate this healthcare problem by commercializing diagnostics and TRPs to facilitate accurate diagnosis and better inform individualized drug therapy decisions.

For more information, visit https://www.ignitebiomedical.com/.

About Calbiotech

Calbiotech, Inc. is a U.S.-based Contract Development and Manufacturing Organization (CDMO) specializing in assay development and manufacturing for the in vitro diagnostics (IVD) industry. Headquartered in California, Calbiotech provides end-to-end development and manufacturing services, including feasibility studies, assay optimization, analytical validation, regulatory support, and commercial production under ISO 13485 certification at its FDA-registered facility. The company partners with diagnostic innovators worldwide to translate novel biomarkers into validated, market-ready products.

For more information, visit https://www.calbiotech.com

Forward-Looking Statements

Forward-looking statements in this press release are based on our future expectations, plans prospects, and assumptions regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "termed," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. Therefore, we caution you against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance.

Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by law.

Investor & Media Contact

Claudio Faria

Chief Executive Officer

[email protected]

SOURCE: Ignite BioMedical