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 >

Platinum Member

Automated Coagulation Analyzer

Hemolumi H6

Gold Member

Clinical Chemistry Assay

Sorbitol Dehydrogenase (SDH)

New

Nucleic Acid Purification Instrument

QIAsymphony Connect

Electrolyte Analyzer

BKE-B

Latest Technology News

Channels

Molecular Diagnostics

view channel

Image: NTM are about 200 environmental bacteria found in soil and water that can cause chronic, tuberculosis-like lung infections but are distinct from the Mycobacterium tuberculosis complex (Image Credit: Adobe Stock)

Rapid CRISPR Test Identifies Nontuberculous Mycobacteria Species from Respiratory Samples

Chronic lung infections caused by nontuberculous mycobacteria (NTM) are increasingly recognized but frequently mistaken for tuberculosis, complicating diagnosis and care. These infections may affect as... Read more

FDA Clears Compact Molecular COVID Test for Decentralized Care Settings

Decentralized healthcare settings such as urgent care clinics have historically struggled to deploy high-performance molecular testing. Barriers include high upfront costs, fixed testing capacity, large... Read more

Blood-Based DNA Analysis Method Detects Early-Stage Solid Cancers

Early detection of stage I solid cancers remains a significant unmet clinical need. Liquid biopsy approaches that can distinguish tumor-derived signals from background cell-free DNA are therefore drawing... Read more

Combined Blood and Genetic Tests Estimate Timing of Alzheimer’s Symptom Onset

Predicting when Alzheimer’s disease will manifest remains a major clinical challenge, particularly before cognitive decline is evident. Blood biomarkers and genetic risk markers can flag elevated risk,... Read more

Hematology

view channel

New Automated Hemostasis Systems Become Available Across US Laboratories

Hemostasis testing supports critical decisions in surgery, anticoagulation management, and the evaluation of bleeding and thrombotic disorders, but laboratories continue to face rising volumes and complex... Read more

Image: Acute myeloid leukemia is an aggressive blood cancer in which relapse remains a major challenge, making MRD detection critical for risk assessment and treatment planning (Image Credit: Shutterstock)

Variation in AML Residual Disease Testing Prompts Push for Standardization

Acute myeloid leukemia (AML) is an aggressive blood cancer in which relapse after therapy remains a persistent challenge, making measurable residual disease (MRD) detection central to risk assessment and... Read more

Hidden Molecular Mechanism Behind HIT Blood-Clotting Disorder Revealed

Immune-mediated thrombosis following heparin therapy can be sudden and severe, creating urgent diagnostic challenges. In heparin-induced thrombocytopenia (HIT), antibodies against platelet factor 4 (PF4)... Read more

Image: New findings indicate that people with borderline anemia—hemoglobin just above WHO anemia thresholds—face a higher mortality risk than those with higher hemoglobin levels within the normal range (Image Credit: 123RF)

Borderline Anemia May Carry Higher Risk Than Current Thresholds Suggest

Hemoglobin concentration is among the most frequently ordered blood tests in primary and hospital care. In older adults, both high and low values have been linked to adverse outcomes, including cognitive... Read more

Immunology

view channel

Image: Although many people harbor latent Epstein-Barr virus (EBV), growing evidence has linked the virus to MS pathobiology (Image Credit: Adobe Stock)

Blood EBV Activity Biomarkers May Predict Multiple Sclerosis Relapse Months Ahead

Predicting relapse in multiple sclerosis (MS) remains difficult, limiting opportunities for timely intervention and monitoring. Although many people harbor latent Epstein-Barr virus (EBV), growing evidence... Read more

Image Credit: Adobe Stock

New Cellular Map May Help Predict Crohn’s Disease Course in Children

Crohn’s disease in children is a common and debilitating form of inflammatory bowel disease, marked by chronic intestinal inflammation and limited pediatric-specific treatments. Clinicians must decide... Read more

Image Credit: Adobe Stock

Temporal Immune Profiling Reveals How Sepsis States Change Over Time

Sepsis is a life-threatening condition in which the immune response to infection becomes dysregulated, leading to rapid organ failure and death. Although antimicrobials and organ support remain standard... Read more

Study Identifies Immune Cells That Drive Harmful Autoantibody Responses in COVID-19

Autoantibodies that mistakenly attack the body’s own tissues have been linked to severe COVID-19, Long COVID, and increased risk of autoimmune disease. However, the origins of these autoantibodies during... Read more

Microbiology

view channel

Magnetic Nanoparticles Enable More Sensitive Beta-Lactam Allergy Testing

Penicillin allergy labels are common in clinical practice, yet many are incorrect and can lead to suboptimal antibiotic choices. Although 8%–25% of people report a penicillin allergy, only 1%–10% are truly... Read more

Image: Graphical Abstract (Zeyang Shen et al., Shotgun Metagenomics Reveals Skin Microbiome Composition and Function in Infant Atopic Disease, Allergy, 2026. DOI: 10.1111/all.70449)

Infant Skin Microbiome Show Links to Later Eczema and Food Allergies

Eczema, or atopic dermatitis, and food allergies often begin in infancy and are among the earliest stages of the atopic march. Atopic dermatitis alone can affect up to 20% of children, yet objective indicators... Read more

Diagnostic Stewardship Guide Targets Testing Overuse and Hospital Cost Pressures

Hospitals face persistent pressure to improve diagnostic accuracy while reducing unnecessary testing and costs. Misordered or overused assays can complicate infection metrics, trigger penalties, and strain... Read more

Research Strengthens Bundibugyo Virus Outbreak Readiness with Faster Diagnostics

Bundibugyo virus (BDBV), a species of ebolavirus, causes severe hemorrhagic disease and can be difficult to diagnose rapidly during outbreaks. Recent regulatory changes have further complicated swift deployment... Read more

Pathology

view channel

Tumor Budding Grading May Predict Chemotherapy Benefit in Resected Lung Squamous Cancer

Outcomes after resection for lung squamous cell carcinoma (SqCC) vary substantially, and the uneven benefit of adjuvant chemotherapy complicates postsurgical treatment decisions. Pathologic markers that... Read more

CAP Updates Cancer Protocols to Refine Breast Cancer Biomarker Reporting and GIST Molecular Testing

Standardized biomarker reporting and molecular profiling are central to pathology-driven cancer care, but evolving practices require laboratories to keep reporting templates current. These templates capture... Read more

Image: The workflow analyzes slides already generated during routine care, providing added prognostic information without requiring another tissue test (Image Credit: Shutterstock)

AI Spatial Analysis of Routine Slides Helps Predict Pancreatic Cancer Recurrence

Predicting which patients with pancreatic cancer will recur after treatment and surgery remains challenging. Pathology evaluation typically measures residual tumor burden, but recent work found that tumor... Read more

Hybrid Computational Imaging Method Improves Digital Pathology Resolution

Digital pathology depends on high-resolution whole-slide imaging to capture diagnostically relevant cellular and tissue features, yet conventional methods often force trade-offs between speed, cost, and detail.... Read more

Technology

view channel

Image: ADLM recommends that emerging AI tools follow the same professional oversight, quality, validation, and monitoring standards as traditional clinical testing within CLIA’s existing framework (Image Credit: Adobe Stock)

ADLM Calls for CLIA Updates to Support Safe AI Use in Laboratory Medicine

Clinical laboratories increasingly use artificial intelligence to verify, interpret, and report results, but safeguards under the Clinical Laboratory Improvement Amendments (CLIA) were designed in 1992.... Read more

Multimodal AI Framework Aims to Guide Cancer Immunotherapy Decisions

Cancer immunotherapy has reshaped oncology, but heterogeneous responses and immune-related toxicities continue to complicate routine decision-making. Standard biomarkers, including programmed death-ligand... Read more

New Multipurpose Centrifuge Combines High Capacity with Sustainable Cooling

Laboratories often need centrifugation that accommodates multiple vessel formats while maintaining controlled temperatures to protect sensitive samples. Intuitive controls and repeatable operation can... Read more

Bacterial Vesicle Expression System Streamlines Production of Cancer Diagnostic Proteins

Recombinant proteins are central to many cancer diagnostics and therapies, but numerous targets remain difficult and costly to produce because they are unstable, toxic to microbial hosts, or require precise folding.... Read more

Industry

view channel

Veracyte Acquisition Expands Urine-Based Bladder Cancer Monitoring Capabilities

Veracyte, Inc. has acquired Convergent Genomics, expanding its urology diagnostics offerings with the company’s UroAmp platform and proprietary urinary tumor DNA (utDNA) technology. UroAmp has been clinically... Read more

Image: Concentriq AP-Dx supports primary diagnosis from digital pathology slides and is FDA-cleared, Health Canada-licensed, and CE-marked under the EU IVDR. (Photo courtesy of Proscia)

Unilabs Expands Digital Pathology Across European Network with Proscia Platform

As precision medicine expands, digital pathology platforms must connect teams, sites, diagnostic data, and artificial intelligence to accelerate routine diagnosis. Sharing expertise across laboratory networks... Read more

Image: Under the theme “From Tissue to Answer”, the launch of VisiOmics anchors a comprehensive pathology portfolio spanning tissue and molecular pathology (Photo courtesy of MGI Tech Co., Ltd.)

MGI Launches Automated Multiplex Tissue Staining and Imaging System at ECP 2026

MGI Tech Co., Ltd. (Shenzhen, China) introduced VisiOmics (PMIF-20RS), a fully automated multiplex immunofluorescence staining and imaging system, at the 38th European Congress of Pathology (ECP 2026)... Read more

Digital Pathology Partnership Integrates Breast Cancer Diagnostic and Prognostic Tools

Breast cancer diagnostics rely on reproducible histological grading and timely interpretation of immunohistochemical biomarkers to guide therapy. Access to prognostic risk profiling can be limited by long... Read more