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Two-year NHLBI CATALYZE award supports clinical validation of the AmyFold Assay, a blood-based test designed to detect transthyretin amyloidosis before irreversible cardiac damage.
SAN DIEGO - Californer -- 3D BioAnalytiX Inc., a San Diego-based biotechnology company developing structural proteomics technologies for earlier disease detection and a 2026 Connect Cool Company, has been awarded approximately $840,000 through the National Heart, Lung, and Blood Institute CATALYZE Program to advance clinical validation of the AmyFold Assay.
The two-year R33 award will support multicenter and longitudinal validation of the AmyFold Assay, a blood-based test designed to detect disease-associated transthyretin, or TTR, misfolding. The project will be led by Sandra Pankow, Ph.D., founder and CEO of 3D BioAnalytiX and principal investigator of the award, in collaboration with investigators at The Scripps Research Institute, Cleveland Clinic, Cedars-Sinai Smidt Heart Institute and Chaparral Inc.
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Transthyretin amyloidosis, or ATTR, is a progressive and substantially underdiagnosed disease and an increasingly recognized cause of heart failure, particularly among older adults. Diagnosis often occurs only after significant cardiac damage has developed, despite the availability of therapies that can slow disease progression.
The AmyFold Assay is designed to identify TTR misfolding, one of the earliest causative molecular events associated with ATTR. Clinical data generated by 3D BioAnalytiX to date suggest the molecular change may be detectable years before ATTR is typically diagnosed using current clinical approaches, with longitudinal data indicating a potential 10- to 20-year earlier detection window.
"Earlier detection could fundamentally change how ATTR is managed because patients have the greatest opportunity to benefit when treatment begins before irreversible organ damage occurs," Pankow said. "This award gives us the opportunity to rigorously validate the AmyFold Assay across multiple clinical settings and move the technology closer to clinical implementation."
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The NHLBI CATALYZE award provides significant non-dilutive support for the next stage of the AmyFold Assay's development while advancing a diagnostic technology developed within San Diego's research and biotechnology ecosystem.
With near-term clinical validation supported by the award, 3D BioAnalytiX is also preparing to raise a seed round to accelerate clinical implementation, regulatory development and commercialization of the AmyFold Assay.
For Connect, the award reflects the continued momentum of its 2026 Cool Companies cohort and the potential for San Diego-based science to translate into technologies that change when disease can be detected and treated.
Connect with Sandra Pankow on LinkedIn:
https://www.linkedin.com/in/sandra-pankow-81277133/
Learn more about 3D BioAnalytiX:
www.3dbioanalytix.com
The two-year R33 award will support multicenter and longitudinal validation of the AmyFold Assay, a blood-based test designed to detect disease-associated transthyretin, or TTR, misfolding. The project will be led by Sandra Pankow, Ph.D., founder and CEO of 3D BioAnalytiX and principal investigator of the award, in collaboration with investigators at The Scripps Research Institute, Cleveland Clinic, Cedars-Sinai Smidt Heart Institute and Chaparral Inc.
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Transthyretin amyloidosis, or ATTR, is a progressive and substantially underdiagnosed disease and an increasingly recognized cause of heart failure, particularly among older adults. Diagnosis often occurs only after significant cardiac damage has developed, despite the availability of therapies that can slow disease progression.
The AmyFold Assay is designed to identify TTR misfolding, one of the earliest causative molecular events associated with ATTR. Clinical data generated by 3D BioAnalytiX to date suggest the molecular change may be detectable years before ATTR is typically diagnosed using current clinical approaches, with longitudinal data indicating a potential 10- to 20-year earlier detection window.
"Earlier detection could fundamentally change how ATTR is managed because patients have the greatest opportunity to benefit when treatment begins before irreversible organ damage occurs," Pankow said. "This award gives us the opportunity to rigorously validate the AmyFold Assay across multiple clinical settings and move the technology closer to clinical implementation."
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The NHLBI CATALYZE award provides significant non-dilutive support for the next stage of the AmyFold Assay's development while advancing a diagnostic technology developed within San Diego's research and biotechnology ecosystem.
With near-term clinical validation supported by the award, 3D BioAnalytiX is also preparing to raise a seed round to accelerate clinical implementation, regulatory development and commercialization of the AmyFold Assay.
For Connect, the award reflects the continued momentum of its 2026 Cool Companies cohort and the potential for San Diego-based science to translate into technologies that change when disease can be detected and treated.
Connect with Sandra Pankow on LinkedIn:
https://www.linkedin.com/in/sandra-pankow-81277133/
Learn more about 3D BioAnalytiX:
www.3dbioanalytix.com
Source: Connect
Filed Under: Business, Innovation
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