Innovita secures NMPA approval for Quanterix's biomarker testing technology in China. 14 Oct 2026 Chinese regulators have approved ultra-sensitive blood-based biomarker testing technology that could enable earlier detection and monitoring of Alzheimer's disease. China's National Medical Products Administration (NMPA) has granted Innovita (Beijing, China) approval for Quanterix's (MA, USA) HD-X and SR-X instruments, along with testing kits for four neurological biomarkers: p-Tau 217, GFAP, p-Tau 181 and NfL. The arrangement combines Quanterix's SIMOA(R)(Single Molecule Array) ultra-sensitive detection technology with Innovita's regulatory capabilities and commercial infrastructure in China, establishing what the companies describe as a broader neurology biomarker portfolio for the Chinese market. The four approved biomarkers provide complementary information on Alzheimer's pathology, neurodegeneration and neuroinflammation, offering insights into early screening, disease monitoring and prognosis. Quanterix's SIMOA(R) technology uses digital immunoassay methods to quantify proteins at the single-molecule level in blood, serum and plasma, detecting biomarkers at concentrations far below traditional limits of quantification. This ultra-sensitive approach is designed specifically to overcome the challenge of measuring low-abundance proteins that conventional immunoassays struggle to identify. The expanding neurology biomarker portfolio includes markers associated with multiple aspects of Alzheimer's disease biology, enabling multi-analyte testing approaches that may offer more comprehensive disease assessment than just biomarkers. "Alzheimer's disease can progress quietly for years - too often, families only get answers after symptoms have progressed and drastically changed their lives. By partnering with Quanterix, we're bringing ultra-sensitive blood-based biomarker testing to China, supporting earlier, more informed clinical decision-making and expanding access to advanced diagnostics for patients and communities who need it most," explained Xiujie Zhang, Chief Executive Officer of Innovita. Innovita plans to submit additional regulatory applications for further Quanterix biomarker diagnostic kits in China, with the aim of integrating SIMOA(R)-powered testing into routine clinical practice. Other long-term aims include expanding beyond Alzheimer's disease into other neurodegenerative conditions and infectious diseases. "Our commercialization arrangement with Innovita is a critical step toward expanding access to ultra-sensitive protein biomarker testing globally and underscores the momentum of our strategy to bring SIMOA(R)-powered diagnostics into large, high-impact IVD markets through strong regional partners," concluded Everett Cunningham, Quanterix Chief Executive Officer.

Quanterix Corporation launches PhenoCode 2.0 molecular barcoding kit, confirms TIME and high-plex ADC panels for Fourth Quarter shipment, and opens custom ADC panel development. Published on 09/25/2026 at 09:21 am EDT S&P Capital IQ Quanterix Corporation reported significant progress on the Content Innovation Engine it introduced at the American Association for Cancer Research (AACR) Annual Meeting 2026, highlighting new updates at the European Society for Spatial Biology (ESSB)September 28-October 1, 2026. Built on the integration of Akoya Biosciences' spatial biology platform and Quanterix's decades of ultra-sensitive, quantitative immunoassay development from the SIMOA(R) technology,the Content Innovation Engine is organized around the hallmarks of cancer framework, giving researchers a systematic, biology-first approach to revealing more from every tissue section. It is supported by the end-to-end capabilities spatial biologists need to advance beyond discovery: world-class spatial instrumentation, assay design and reagent formulation expertise, quality systems, and manufacturing scale to support measurements that meet the requirements of translational and clinical applications. Three programs previewed at AACR have since progressed, one now shipped and two confirmed for delivery in Fourth Quarter 2026, underscoring the pace at which Quanterix is executing against this roadmap. Built on PhenoCode? 2.0 chemistry, the kit has advanced from its early access phase to full commercial release. The kit enables researchers to barcode virtually any antibody with high reliability and yield, extending established panels into applications spanning immuno-oncology, neuroscience, and other research areas without adding workflow complexity. The tertiary lymphoid structure content previewed at AACR as part of the IO60 Spike-In Module has been developed into the TIME panel, a name that reflects its expanded capability to resolve the Tumor Immune Microenvironment in its entirety rather than TLS architecture alone. As a PhenoCycler(R)-Fusion spike-in module compatible with the PhenoCode Discovery IO60 panel, it is on track to ship in the fourth quarter of 2026. Also a PhenoCycler-Fusion spike-in module compatible with IO60, this panel enables co-measurement of ADC target expression alongside tumor immune contexture within a single tissue section, directly addressing the field's growing demand for combination biology readouts at the ADC-immunotherapy interface. Shipment is confirmed for the fourth quarter of 2026. Since introducing a breast cancer ADC panel on PhenoImager HT at AACR 2025 and two NSCLC ADC panels at AACR 2026, the Quanterix Accelerator Laboratory has established a proven track record delivering ADC combination biology as a fully managed service across three panels and two indications. The Accelerator Laboratory is now accepting requests for custom ADC panel development: biopharma and translational teams define the indication, tissue type and marker set, and the Accelerator team designs, optimizes and validates the panel to their specification. Custom ADC development is part of the Quanterix Accelerator Laboratory's fully managed tissue biomarker services, which spans the path from discovery to the clinic. The lab uses PhenoCycler-Fusion for high-plex biomarker discovery and tumor microenvironment characterization. It then translates the most informative markers into targeted, high-throughput PhenoImager HT panels for large-cohort and clinical trial sample testing. Assays follow a tiered validation approach, from research use through the analytical validation expected of clinical trial assays. The work is performed in a laboratory operating under CLIA, GCLP, and ISO 15189 quality frameworks, supported by dedicated histology, pathology, quality assurance, and project management teams. (C) S&P Capital IQ - 2026