CelLBxHealth PLC Presents Proof-of-Concept Study

Rhea-AI Summary

CelLBxHealth (OTCQX:ANPCY / AIM:CLBX; ADR symbol ANPCF) presented a proof-of-concept study at the 16th World ADC Conference (Nov 3-6, 2025) showing the Parsortix® platform and CellKeep slide are compatible with Roche Tissue Diagnostics' BenchMark ULTRA automated IHC workflow.

Key points: blood samples and fixed cancer cell lines were processed and sent to Roche for automated IHC analysis using HER2, TROP2, and PSMA assays; BenchMark ULTRA staining was reported compatible with CelLBxHealth's manual immunofluorescent workflow; the release highlights CTCs as dynamic biomarkers that may support ADC patient selection.

Positive

• Compatibility demonstrated with HER2, TROP2, PSMA assays
• Samples processed and shipped for automated IHC analysis
• Presentation at World ADC Conference Nov 3-6, 2025
• BenchMark ULTRA throughput of 95 patient samples per minute

Negative

• None.

11/05/2025 - 02:00 AM

CelLBxHealth presents proof-of-concept study using Roche Tissue Diagnostics' workflow at world-leading drug development conference

• Parsortix platform shown to be compatible with the Roche BenchMark ULTRA automated staining system, with initial study of three key drug targets: HER2 (breast), TROP2 (lung) and PSMA (prostate)

GUILFORD, SURREY AND PLYMOUTH MEETING, PA / ACCESS Newswire / November 5, 2025 / CELLBXHEALTH plc (AIM:CLBX)(OTCQX:ANPCY), a global leader in circulating tumour cell (CTC) intelligence, announces the presentation of a proof-of-concept study using a Roche Tissue Diagnostics workflow at the 16^th World ADC conference, San Diego, USA (Nov 3-6). The World ADC Conference is the largest global event dedicated to antibody-drug conjugates (ADCs), attracting over 1,400 attendees focused on advancing targeted cancer therapies.

Roche is a major diagnostics player, holding a significant share of the overall tissue testing market. The Roche BenchMark ULTRA system is considered a world leading clinical automated staining platform, with 95 patient samples processed every minute, equating to more than 50 million samples a year¹.

The study showcases a novel workflow combining CelLBxHealth's Parsortix® platform and proprietary CellKeep slide with Roche's BenchMark ULTRA automated immunohistochemistry (IHC) staining platform for cell visualisation and biomarker analysis across key ADC targets: HER2, TROP2, and PSMA.

Key findings from the collaboration include:

• Blood samples were successfully processed and cancer cell lines fixed and shipped to Roche Tissue Diagnostics' site for automated IHC analysis using Roche Tissue Diagnostics' HER2, TROP2 and PSMA assays

• For all biomarkers the BenchMark ULTRA automated IHC staining was compatible with CelLBxHealth's manual immunofluorescent staining workflow

Characterisation of CTCs can overcome the limitations of tissue biopsies in cancer care. A simple blood test offers a safer, faster, and less costly alternative, enabling repeated testing when tissue isn't available. Since cancer changes over time and with treatment, real-time monitoring is critical. As living cells shed from the tumour into the blood, CTCs provide a dynamic and up-to-date view of the patient's disease status.

The ADC market continues to grow rapidly, driven by the need for targeted, effective treatments with fewer side effects. Integrating CTC-based biomarker assessment into ADC development and clinical use could help optimise patient selection and improve outcomes. CTCs are considered better biomarkers than circulating tumour DNA (ctDNA) for selecting patients for ADC treatment primarily because CTCs allow for the direct analysis of the target protein expression on the cell surface, a critical requirement for ADC efficacy.

Peter Collins, Chief Executive Officer of CelLBxHealth, said: "We are pleased to present initial results on our proof-of-concept study undertaken using Roche Tissue Diagnostics' workflow. It is well known that targeted treatments that utilise biomarkers improve patient outcomes. As such, this study highlights the importance of targeted antigen expression on CTCs and their relevance for potentially guiding ADC therapy selection in real-time.

CelLBxHealth believes these results highlight CTCs as accessible, dynamic biomarkers in oncology. Leading experts believe that CTCs are poised to add clinical utility to the metastatic landscape²."

For more information, visit www.cellbxhealth.com.

References:

1. www.diagnostics.roche.com/us/en/products/instruments/discovery-ultra-ins-2210.html

2. Nicolò, E., et al. (2025). International expert consensus on the clinical integration of circulating tumor cells in solid tumors. European Journal of Cancer, 231, 116050. https://doi.org/10.1016/j.ejca.2025.116050

For further information:

CelLBxHealth plc Peter Collins, Chief Executive Officer	+44 (0) 1483 343434 investors@CelLBxHealth.com
Cavendish (NOMAD and Broker) Geoff Nash / Isaac Hooper (Corporate Finance) Sunila de Silva (Corporate Broking) Nigel Birks (Life Science Specialist Sales)	+44 (0) 20 7220 0500
FTI Consulting Simon Conway, Ciara Martin, Sam Purewal Matthew Ventimiglia (US)	+44 (0) 203 727 1000 +1 (212) 850 5624

Notes for editors

About CelLBxHealth plc

CelLBxHealth plc is a global precision CTC intelligence company specialising in innovative circulating tumour cell (CTC) solutions for use in research, drug development and clinical oncology. Its patent-protected Parsortix® platform harvests CTCs from blood and can be seamlessly integrated with existing laboratory instruments for comprehensive downstream analysis - including whole-cell imaging, proteomic profiling and full genomic workflows.

Commercial activities centre on (1) Product Sales: Accelerating Parsortix platform adoption and consumable sales through CROs* and clinical lab partnerships. (2) Lab Developed Tests (LDTs): Strategic partnerships combined with a focused in-house development programme (3) Laboratory services: Clinical trial support and assay development.

The product portfolio comprises the Parsortix® platform with associated consumables and assays. Laboratory services are delivered from CelLBxHealth's GCLP certified UK laboratory, providing bespoke clinical-trial support and assay development.

For more information, visit www.CelLBxHealth.com

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SOURCE: CellBxHealth PLC

View the original press release on ACCESS Newswire

FAQ

What did CelLBxHealth (ANPCF) present at the World ADC Conference on Nov 3-6, 2025?

A proof-of-concept study showing Parsortix and CellKeep slides are compatible with Roche BenchMark ULTRA IHC for HER2, TROP2, and PSMA assays.

Which biomarkers were tested in CelLBxHealth's ANPCF proof-of-concept study?

The study tested HER2 (breast), TROP2 (lung), and PSMA (prostate).

How does the Roche BenchMark ULTRA relate to CelLBxHealth's workflow in the ANPCF study?

BenchMark ULTRA handled automated IHC staining and was reported compatible with CelLBxHealth's manual immunofluorescent workflow.

Why are circulating tumour cells (CTCs) important according to the ANPCF announcement?

CTCs offer a less invasive, repeatable blood test that can provide real-time target protein expression for ADC patient selection.

Does the ANPCF release quantify Roche BenchMark ULTRA throughput?

Yes; the BenchMark ULTRA is cited as processing 95 patient samples per minute, equating to over 50 million samples a year.