NanoMosaic to Showcase the FDA/CBER AMT Designated Analytics Platform at ASGCT 2026

Beyond ddPCR for Gene Therapy: The Tessie™ system enables simultaneous capsid and transgene quantitation on a single chip in the same run, supporting accurate full, partial, and empty capsid characterization, potency assessment, and regulatory-relevant AAV quality control.

BOSTON, April 29, 2026 /PRNewswire/ -- NanoMosaic, Inc., a leader in advanced analytical technologies for cell and gene therapy development and manufacturing, today announced its strong scientific and commercial presence at the American Society of Gene & Cell Therapy Annual Meeting, taking place May 11-15, 2026, in Boston, Massachusetts.

NanoMosaic will highlight the capabilities of its Tessie™ system, the company's flagship nanoneedle-based analytical platform and the only FDA/CBER Advanced Manufacturing Technology-designated technology for multiplex testing of vector genome and capsid titers in AAV gene therapy manufacturing.

The Tessie system enables simultaneous, high-throughput quantitation of capsid and transgene on a single chip in the same run, helping developers directly assess critical AAV quality attributes in one integrated workflow. By measuring capsid and genome-related attributes together, Tessie is designed to reduce assay-to-assay bias, distinguish partials from full capsids, and provide a more accurate assessment of the true full-to-empty and full-to-partial ratio. The platform can also support potency-related assays, giving gene therapy developers and manufacturers deeper insight into product quality, process performance, batch consistency, and release-readiness.

"ASGCT is the ideal venue to highlight how far the field has come, and how much more analytical precision is now required to advance gene therapies safely, efficiently, and with confidence," said John Boyce, Chief Executive Officer of NanoMosaic. "With Tessie, developers can measure capsid and transgene on one chip, at the same time, helping eliminate the bias that can occur when critical quality attributes are measured separately. This provides a clearer picture of true product composition, including partials versus fulls, and gives developers the regulatory-relevant data they need to move faster."

NanoMosaic's platform recently received FDA/CBER Advanced Manufacturing Technology (AMT) designation for multiplex testing of vector genome and capsid titers in AAV gene therapy manufacturing. Through the AMT designation program, gene therapy developers implementing NanoMosaic's platform will gain access to enhanced FDA engagement, prioritized regulatory interactions, and expedited IND and BLA review pathways.

At ASGCT, NanoMosaic will be featured across five scientific posters, including three customer-led posters and two NanoMosaic-authored posters, as well as one oral presentation to highlight its recent AMT designation and the significant advantages it offers developers in streamlining gene therapy development and manufacturing.

NanoMosaic ASGCT 2026 Presentations

Posters:

Catalent: Poster No. 2212
Title: Enhancing AAV empty/full ratio accuracy: Utilizing molecular specificity to differentiate full-length from truncated transgenes
Date/Time: 5/13/2026, 5:00PM-6:30PM

Brown University: Poster No. 1221
Title: Overcoming an analytical bottleneck in gene therapy: a rapid and precise nanoneedle immunoassay method for detection and quantification of adeno-associated virus capsid and transgene titer
Date/Time: 5/12/2026, 5:00PM-6:30PM]

UMass Chan Medical School,: Poster No. 3220
Title: Improving AAV quality assessment using nanoneedle assays for full-length genome and capsid quantification
Date/Time: 5/14/2026, 5:00PM-6:30PM

NanoMosaic Poster 1 launching the RNA quantification assay on Tessie system: Poster No. 3222
Title: Integrated AAV genome integrity and transgene RNA quantification using a single nanoneedle-based platform
Date/Time: 5/14/2026, 5:00PM-6:30PM

NanoMosaic Poster 2 showcasing automated workflow on Tecan Veya platform: Poster No. 3154
Title: Automated nanoneedle assay workflow on Tecan Veya multiomics platform for scalable AAV manufacturing quality control
Date/Time: 5/14/2026, 5:00PM-6:30PM

Oral Presentation:
Speaker: Qimin Quan, PhD., Co-Founder and Chief Scientific Officer, NanoMosaic
Title: Accelerating AAV development with an FDA/CBER AMT-designated nanoneedle analytics platform
Session: Analytics & Assays: New tech
Date/Time: 5/14/2026, 9:30AM
Location: MCEC Room 206AB

"Gene therapy manufacturing has relied on proxy measurements to infer the genome integrity inside the capsid," said Qimin Quan, PhD, Co-Founder and Chief Scientific Officer of NanoMosaic. "Tessie eliminates the ambiguity of these surrogate methods by enabling direct molecular-level quantification of AAV full-length and partial transgenes, as well as capsids. By delivering these insights across the entire workflow – from crude samples in the upstream development to final release testing – we are ensuring a faster, more reliable path to clinic."

Conference attendees are invited to visit NanoMosaic at Booth No.1732 to meet the team and learn how the Tessie system can help advance AAV analytics, reduce regulatory uncertainty, and support expedited development pathways through NanoMosaic's FDA/CBER AMT designation.

About NanoMosaic

NanoMosaic Inc. is a pioneering biotechnology company developing innovative tools and technologies for multiomic biomarker detection and analysis. The company's flagship product, the NanoMosaic Tessie™ system, is a high-throughput platform for biomarker detection that enables researchers to analyze multiple samples simultaneously with high sensitivity and specificity across proteins and nucleic acids on the same run. The system is designed to provide novel Critical Quality Attributes for cell and gene therapy development and manufacturing and to accelerate the discovery and development of biomarkers across a wide range of applications, including disease diagnosis, drug discovery, and precision medicine.

Media Contact:
Paul Berning
NanoMosaic, Inc
[email protected]
+1-319-480-9464
www.nanomosaicllc.com

SOURCE NanoMosaic