We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Dedicated Blood DNA Collection Tube Receives European Marketing Approval

By LabMedica International staff writers
Posted on 13 Feb 2014

Image: The PAXgene Blood DNA Tube (Photo courtesy of PreAnalytiX GmbH).

Image: The PAXgene Blood DNA Tube (Photo courtesy of PreAnalytiX GmbH).

A new collection tube for routine clinical use that was designed to preserve DNA in blood samples was recently certified for use as a diagnostic product in Europe.

The PreAnalytiX GmbH (Feldbachstrasse, Switzerland) PAXgene Blood DNA Tube provides a means for the collection of whole blood for the isolation of genomic DNA in a closed, evacuated system. Blood is collected under a standard phlebotomy protocol into an evacuated tube that contains potassium-EDTA additive. Complete isolation of DNA is carried out using manual or automated methods such as salting out precipitation, magnetic beads, or silica membrane-based technologies.

The 2.5 milliliter PAXgene Blood DNA Tube stabilizes genomic DNA with validated time and temperature parameters. The tube incorporates workflow efficiency features including a two-dimensional bar code on the label and a tube closure that clearly identifies this unique DNA collection tube.

The PAXgene tube, which recently received the European Union's CE marking IVD certification for sale in Europe was developed as part of a joint venture between Becton Dickinson and Company ((Franklin Lakes, NJ, USA) and QIAGEN (Venlo, The Netherlands).

“The validated performance data we provide to clinical scientists for the PAXgene Blood DNA Tube should reduce the chances of preanalytical error, ensuring the best quality sample for accurate IVD test performance and for blood DNA storage related to the identification of new biomarkers of disease or drug actions,” said Frank Augello, general manager of PreAnalytiX GmbH.

Related Links:
PreAnalytiX GmbH
Becton Dickinson and Company
QIAGEN

Visit expo >

New

Gold Member

Aspiration System

VACUSAFE

New

Gold Member

STI Test

Vivalytic MG, MH, UP/UU

New

Steam Sterilizer

Hi Vac II Line

New

CMV CLIA Diagnostic

CLIA CMV IgA Screen Group

Latest Technology News

Channels

Molecular Diagnostics

view channel

Portable Test Detects Tuberculosis from Tongue Swabs in 30 Minutes

Despite decades of effective drug regimens, tuberculosis remains the leading cause of death from an infectious disease, driven in part by limited access to accurate, rapid testing. Conventional diagnostics... Read more

Blood Test Receives FDA Breakthrough Status to Differentiate Schizophrenia and Bipolar Disorder

Differentiating schizophrenia from bipolar I disorder in symptomatic patients is challenging because early presentations often overlap. Current diagnostic pathways rely heavily on subjective assessments... Read more

Genomic Risk Score Identifies Inherited Risk for Multiple Cardiovascular Conditions

Cardiovascular disease is the leading cause of death worldwide, yet many at‑risk individuals are overlooked by traditional calculators. Tools that weigh age, sex, blood pressure, and cholesterol can miss... Read more

Routine Genetic Marker May Help Guide Targeted Therapy in Acute Leukemia

Acute myeloid leukemia (AML) is an aggressive blood cancer with widely variable treatment outcomes between patients. Choosing which individuals will benefit from targeted agents remains difficult, limiting... Read more

Hematology

view channel

Advanced CBC-Derived Indices Integrated into Hematology Platforms

Diatron, a STRATEC brand, has introduced six advanced hematological indices on its Aquila, Aquarius 3, and Abacus 5 hematology analyzers. The new Research Use Only (RUO) indices include Neutrophil-to-Lymphocyte... Read more

Blood Test Enables Early Detection of Multiple Myeloma Relapse

Bone marrow biopsies remain central to diagnosing and monitoring multiple myeloma, yet the procedure is painful, invasive, and often repeated over time. Older patients—who represent most new cases—can... Read more

Single Assay Enables Rapid HLA and ABO Genotyping for Transplant Matching

CareDx (Brisbane, CA, USA) has introduced AlloSeq Nano, a nanopore‑based HLA (human leukocyte antigen) and ABO genotyping solution unveiled at the European Federation for Immunogenetics (EFI) Conference 2026.... Read more

Image: Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma and often presents with aggressive clinical behavior (photo courtesy of Shutterstock)

Prognostic Biomarker Identified in Diffuse Large B-Cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma and often presents with aggressive clinical behavior. Although many patients respond to standard chemotherapy with... Read more

Immunology

view channel

Study Highlights Low Sensitivity of Current Lyme Tests in Early Infection

Accurate laboratory diagnosis of early Lyme disease remains challenging because serologic responses may be limited soon after infection. Missed detection at this stage can delay evaluation and management... Read more

Image: Graphical abstract - Human immune aging clock identifies RUNX1 as a decelerator of T cell senescence (photo courtesy of Zhang Weiqi)

Immune Aging Clock Quantifies Immunosenescence and Identifies Therapeutic Target

Immune aging undermines host defense and contributes to multiple age-related diseases, yet its heterogeneity complicates measurement and intervention. Clinical laboratories increasingly seek objective... Read more

Study Finds Influenza Often Undiagnosed in Winter Deaths

Seasonal influenza drives substantial excess mortality, yet its contribution is often obscured when infections go undiagnosed near the time of death. Many deaths occur outside hospitals or in older adults... Read more

Combined Screening Approach Identifies Early Leprosy Cases

Leprosy remains a significant public health concern, with more than 200,000 new cases reported globally each year and early disease often escaping routine laboratory detection. In its initial phase, bacterial... Read more

Microbiology

view channel

Image: Biosensor for tuberculosis detection (photo courtesy of UPV)

Rapid Antigen Biosensor Detects Active Tuberculosis in One Hour

Tuberculosis remains a major global health challenge and continues to drive significant morbidity and mortality. The World Health Organization’s 2024 global report cites it as the leading cause of death... Read more

Image: Graphical abstract (Qin, Y. et al., Cell Rep Med 7: 102761 (2026). DOI: 10.1016/j.xcrm.2026.102761)

Oral–Gut Microbiome Signatures Identify Early Gastric Cancer

Early detection of gastric cancer could be advanced by scalable screening strategies using minimally invasive sampling. Saliva collection is noninvasive and cost-effective, supporting wider adoption... Read more

Image: Magnetic field-enhanced alignment and detection of hemozoin in lysed infected red blood cells using polarizing microscopy (photo courtesy of Dickson Mwenda Kinyua, Kirinyaga University)

Label-Free Microscopy Methodd Enables Faster, Quantitative Detection of Malaria

Microscopy of blood smears remains a cornerstone for malaria diagnosis but can be slow, stain-dependent, and operator intensive. With more than 200 million infections and over 600,000 deaths annually,... Read more

Gut Microbiome Test Predicts Melanoma Recurrence After Surgery

Melanoma remains prone to relapse even after surgery and adjuvant immunotherapy, with 25% to 40% of patients experiencing recurrence. Clinicians lack reliable pre-treatment indicators to identify those... Read more

Pathology

view channel

Image: Study flowchart. This study developed a multimodal artificial intelligence framework to predict PIK3CA mutations in breast cancer (Jiaxian Miao et al., Cancer Biol Med 23(3): 430–450 (2026). DOI: 10.20892/j.issn.2095-3941.2025.0771)

Multimodal AI Tool Predicts Genetic Alterations to Guide Breast Cancer Treatment

PIK3CA mutations are key biomarkers for selecting phosphoinositide 3-kinase (PI3K)–targeted therapies in breast cancer, yet access to molecular testing can be inconsistent and costly. Conventional polymerase... Read more

Image: Overview of the MorphoGenie framework (Murthy, R.S., Stassen, S.V., Siu, D.M.D. et al. Nat Commun 16, 11465 (2025). doi.org/10.1038/s41467-025-66267-w)

Interpretable AI Reveals Hidden Cellular Features from Microscopy Images

Microscopy images contain rich clues about cell health, but many disease-relevant morphological differences are too subtle to see and difficult to quantify consistently. Artificial intelligence (AI) has... Read more

Tumor Immune Structure Predicts Response to Immunotherapy in Melanoma

Many patients with advanced melanoma start on anti-PD-1 immunotherapy, but responses can wane or never develop. Clinicians often turn to anti-CTLA-4 after resistance emerges, yet predicting who will respond... Read more

Image: The PRET system provides an integrated solution for multiple pathology diagnostic tasks, including cancer screening, tumor subtyping, tumor segmentation, and lymph node metastasis detection (Li, Y., Ning, Z., Xiang, T. et al. Nature Cancer (2026). doi.org/10.1038/s43018-026-01141-2)

Plug-and-Play AI Pathology System Classifies Multiple Cancers from Few Slides

Pathologists are essential for cancer diagnosis and treatment planning, yet a global workforce shortage is straining services. Nearly 20 million new cases are diagnosed each year, and traditional artificial... Read more

Technology

view channel

Microfluidic Single-Cell Assay Predicts Breast Cancer Risk

Risk stratification for breast cancer remains imprecise, as population-based models and breast density can over- or underestimate individual risk, potentially leading to over- or under-screening.... Read more

AI Tool Predicts Non-Response to Targeted Therapy in Colorectal Cancer

Advanced bowel cancer remains difficult to treat, and many patients receive targeted therapies that do not help them but still cause harm. Clinicians need reliable ways to identify likely responders before... Read more

Integrated System Streamlines Pre-Analytical Workflow for Molecular Testing

Pre-analytical variation remains a leading source of inconsistent molecular test results and added costs, particularly when laboratories rely on multiple instruments and protocols. Standardizing nucleic... Read more

Noninvasive Sputum Test Detects Early Lung Cancer

Early detection remains critical for improving outcomes in lung cancer, yet clinicians increasingly encounter indeterminate pulmonary nodules found incidentally or through screening, complicating decision-making.... Read more

Industry

view channel

CareDx Expands Precision Oncology Portfolio with Naveris Acquisition

CareDx Inc. (Brisbane, CA, USA), a precision medicine company advancing clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, has entered a definitive agreement... Read more

Thermo Fisher Scientific to Sell Microbiology Business to Astorg

Thermo Fisher Scientific has signed a definitive agreement to sell its microbiology business to Astorg for approximately $1.075 billion, comprising cash and a $50 million seller note. Announced on April... Read more

Collaboration Expands Access to Rapid Metagenomic Diagnostics for Complex Infections

Hospitals are seeing rising rates of complicated and healthcare-associated infections, especially in immunocompromised patients, intensifying the need for rapid, comprehensive pathogen detection.... Read more

Image: The acquisition adds the LEX VELO System to QuidelOrtho’s portfolio (photo courtesy of LEX Diagnostics)

QuidelOrtho Adds Ultra-Fast PCR Platform with LEX Acquisition

QuidelOrtho Corporation has completed the acquisition of LEX Diagnostics for approximately USD 100 million in cash. The transaction adds the LEX VELO System to QuidelOrtho’s portfolio. The platform received U.... Read more