Hematogenix @hematogenix

Every regulatory milestone is supported by rigorous clinical research and high-quality scientific evidence. A key part of this process is the use of well-defined clinical trial endpoints, predefined measures that help evaluate a therapy's efficacy and contribute to the evidence considered during regulatory review. One recent example is the FDA's accelerated approval of ZENBEXUS™ (iberdomide). In the Phase 3 EXCALIBER-RRMM trial, MRD-negative complete response at any time was the major efficacy outcome measure and was assessed using Hematogenix's proprietary Multiple Myeloma MRD Next Generation Flow Cytometry assay. This milestone highlights the importance of robust clinical trial design and standardized laboratory methodologies in generating reliable evidence to support oncology drug development. Read the full press release: hematogenix.com/resources/pres… #ClinicalTrials #MultipleMyeloma #MRD #FlowCytometry #Oncology #FDAApproval

Every blood cancer diagnosis starts with uncertainty; for the patient, for their family, and for the healthcare teams working to find the right path forward. Getting an accurate diagnosis isn't always straightforward. Many blood cancers can appear similar, yet differ significantly in their biology, how they behave, and their treatment approach. Establishing diagnostic clarity often requires combining expertise with specialized diagnostic testing. At Hematogenix, we're proud to work alongside our partners to help answer these questions. Through our specialized hematopathology and molecular diagnostic capabilities, we provide the insights that support informed decisions in both patient care and research. This Blood Cancer Awareness Month, we recognize everyone committed to advancing the understanding, diagnosis, and treatment of blood cancers. Because every diagnostic insight has the potential to shape what comes next for patients, their families, and the healthcare professionals who care for them. #BloodCancerAwarenessMonth #BloodCancer #Hematology #MolecularDiagnostics

Join us at IMS 2026. We'll be in Glasgow for the 23rd International Myeloma Society Annual Meeting. Visit our booth to connect with us and learn how our Multiple Myeloma Suite supports precision diagnosis, MRD monitoring, and treatment decisions. See you there. linkedin.com/company/intern… #IMS2026 #IMS26 #MultipleMyeloma #Hematology #Hematogenix

Another Milestone in Quality Excellence We are proud to share that Hematogenix UK has successfully completed its latest College of American Pathologists (CAP) inspection, with NO DEFICIENCIES cited. This achievement marks the third consecutive CAP inspection with NO DEFICIENCIES for our UK laboratory, joining our Malaysia facility in reaching this important milestone and reinforcing the high standards that define our laboratory operations. Every successful inspection reflects more than compliance, it reflects the dedication of our teams, the strength of our quality systems, and our commitment to delivering accurate, reliable laboratory results that support clinical research, informed decision-making, and ultimately better patient care. Congratulations to our Hematogenix UK team on this outstanding achievement, and thank you for your professionalism, collaboration, and commitment to excellence every day. #CAPAccreditation #LaboratoryQuality #QualityAssurance #Pathology #ClinicalDiagnostics #PatientCare #Hematogenix #UK

A great milestone for Hematogenix, supporting the FDA accelerated approval of Bristol Myers Squibb's ZENBEXUS TM (iberdomide), the first approved CELMoD therapy for multiple myeloma. biospace.com/press-releases…

Hematogenix's proprietary MM MRD assay was used to assess the pivotal efficacy endpoint supporting the FDA accelerated approval of Bristol Myers Squibb's ZENBEXUS TM (iberdomide), the first approved CELMoD therapy for multiple myeloma. According to the FDA-approved prescribing information, MRD-negative complete response, the trial's primary efficacy endpoint was assessed using Hematogenix's Next Generation Flow Cytometry assay at a sensitivity threshold of 10⁻⁵, enabling the detection of one myeloma cell among 100,000 normal cells. In the Phase 3 EXCALIBER-RRMM trial, patients treated with ZENBEXUS TM in combination with daratumumab and hyaluronidase-fihj and dexamethasone achieved an MRD-negative complete response rate of 41%, compared with 21% for patients treated with daratumumab, bortezomib, and dexamethasone. This statistically significant improvement formed the basis of the FDA's accelerated approval. As MRD continues to gain recognition as an important endpoint in multiple myeloma clinical trials, robust and standardized MRD assessment is becoming increasingly important in supporting oncology drug development and regulatory decision-making. Read the full announcement: hematogenix.com/resources/pres… #MultipleMyeloma #MRD #Oncology #ClinicalTrials #FlowCytometry

We are proud and excited to share Hematogenix involvement in a breakthrough new treatment of Multiple Myeloma. Hematogenix's proprietary MM MRD assay served as the analytical method for the pivotal efficacy endpoint supporting the FDA accelerated approval of Bristol Myers Squibb's ZENBEXUS (iberdomide), the first approved CELMoD therapy for multiple myeloma. This milestone highlights the growing importance of high-quality MRD assessment in registrational oncology trials and reflects our collaboration with Bristol Myers Squibb in supporting the development of innovative therapies. Read the full announcement: hematogenix.com/resources/pres… #MultipleMyeloma #MRD #Oncology #ClinicalTrials #Hematogenix

Three consecutive CAP inspections, with no deficiencies. We are proud to announce that Hematogenix Malaysia has successfully completed its latest CAP inspection with no deficiencies cited, marking the third consecutive inspection in Malaysia with this result. This achievement reflects the expertise of our team and the strength of the quality systems that guide our work. Across Hematogenix laboratories worldwide, our shared commitment is to deliver accurate, reliable laboratory results that strengthen the confidence of our clients and partners, support informed clinical and research decisions, and ultimately contribute to better patient care. We extend our sincere appreciation to every member of the Hematogenix Malaysia team whose dedication and professionalism made this milestone possible. #CAPAccreditation #LaboratoryQuality #QualityAssurance #Pathology #ClinicalDiagnostics #PatientCare #Hematogenix #Malaysia

One assay. Comprehensive myeloid insights. In myeloid malignancies (AML, MDS, and MPN), multiple co-occurring driver mutations can make diagnosis and treatment decisions more complex. Conventional or limited gene testing may not capture the full genomic landscape. Our targeted 73-gene NGS panel, covering 5,000+ clinically curated variants, enables comprehensive molecular profiling in a single assay and supports both baseline genotyping and MRD monitoring for earlier relapse detection. Better-informed decisions through precision oncology. #NGS #Oncology #PrecisionMedicine #MRD #ClinicalTrials #Biopharma

Biomarker assay sensitivity matter In oncology clinical trials, low-abundance biomarkers can be difficult to detect, especially in early disease or during minimal residual disease (MRD) monitoring. Insufficient assay sensitivity may impact patient stratification, treatment monitoring, and endpoint evaluation. Reliable detection depends on: • High-sensitivity assay technologies • Rigorous analytical validation • Standardized laboratory workflows • Consistent performance across sites At Hematogenix, we combine assay development, analytical validation, and standardized workflows to support reliable biomarker detection in oncology clinical trials. How does assay sensitivity influence biomarker-driven clinical decisions? #OncologyResearch #ClinicalTrials #Biomarkers #PrecisionMedicine #AssayValidation

Why does assay standardization matter in global oncology trials? In multi-regional studies, data is generated across different laboratories, instruments, operators, and timelines. Without standardization, even small analytical differences can introduce variability that impacts biomarker interpretation and data comparability. Standardized assays help ensure consistent analytical performance, harmonized interpretation, and reproducible results across study sites. This is particularly important in oncology, where molecular and cellular biomarkers increasingly influence trial decisions and outcomes. By reducing variability and supporting data consistency, assay standardization helps strengthen trial integrity and confidence in study results. #ClinicalTrials #OncologyResearch #PrecisionMedicine #AssayStandardization

In global clinical trials, testing variability can quietly compromise data consistency. Hematogenix supports global studies through harmonized SOPs, unified quality systems, standardized platforms, validated assays, and aligned training across sites in the US, UK, Poland, Türkiye, China, and Malaysia. This integrated model helps pharma and biotech partners run global trials with confidence, supporting consistent, reproducible, high-quality data across regions. When infrastructure is operationally standardized, geographic expansion becomes a strength, not a source of variability. #ClinicalTrials #OncologyResearch #PrecisionOncology #GlobalDiagnostics

AI in oncology research is moving beyond automation. It's real value lies in connecting multi-omics, digital pathology, and clinical data to generate deeper biological insights. But rigor matters. AI outputs are only as strong as the assay quality, pathology interpretation, and data behind them. At Hematogenix, we combine advanced analytics with oncology expertise to ensure insights are robust and clinically meaningful. Where do you see AI adding the most value next? #AI #Oncology #PrecisionMedicine #ClinicalTrials

Tumor biology evolves across blood, bone marrow, and lymphoid tissues, requiring highly sensitive and reproducible approaches. In clinical trials, variability in biomarker detection or molecular characterization can affect patient stratification, endpoint interpretation, and data consistency. At Hematogenix, we integrate flow cytometry, NGS, IHC/FISH, and digital pathology for reproducible hematologic trial results. Precision doesn’t just generate data it ensures insights are robust, comparable, and decision-ready. From PD-L1 CDx to MRD, our global CAP/CLIA labs help minimize variability. In your experience, where does variability impact results the most in hematologic studies? #Hematology #MolecularDiagnostics #TranslationalResearch

Misaligned assay data can delay oncology drug development. Inconsistent results may trigger regulatory queries, require repeat analyses, and undermine confidence in trial conclusions. Consistent analytical frameworks and quality‑focused laboratory practices are essential for reliable biomarker data in clinical studies. Reliable assays strengthen clinical evidence and help streamline regulatory approval pathways. #Oncology #ClinicalTrials #Biopharma

Clinical trials are built on precision. Excessive variability compromises outcomes. In oncology drug development, trial integrity depends on diagnostic data that is reproducible, analytically trusted, and comparable across sites and platforms. At Hematogenix, standardized high‑complexity oncology assays are designed to ensure data equivalence, minimize variability, and generate regulatory‑ready datasets. #ClinicalTrials #OncologyResearch #PrecisionDiagnostics #DrugDevelopment

In oncology, fragmented data slows progress and complicates decision‑making. An integrated diagnostic framework brings molecular, cellular, and pathology insights together, enabling consistent, high‑quality data across research, clinical trials, and drug development. Scientific rigor. Unified platforms. Confident decisions. How important is unified infrastructure in your programs? #Oncology #ClinicalResearch #PrecisionMedicine #Diagnostics

Pathology is where oncology data gains diagnostic meaning. Beyond generating results, expert pathology interpretation determines how tissue findings are understood, contextualized, and translated into decisions across research and drug development programs. At Hematogenix, our pathology services deliver clear, consistent interpretation of complex oncologic specimens, supporting biopharma and clinical research teams throughout the clinical development lifecycle. When evaluating oncology study data, what makes you trust it most? #PathologyServices #PrecisionMedicine #OncologyAssays #Biopharma