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

Neonatal Heel Incision Device

Tenderfoot

POC Helicobacter Pylori Test Kit
Hepy Urease Test

New

Immunofluorescence Analyzer

IFA System

New

Total Laboratory Automation Solution

SATLARS Mini T8

Latest Technology News

Channels

Molecular Diagnostics

view channel

New AI Tool Improves Detection of Genetic Causes in Rare Disorders

Families affected by rare diseases often endure years of inconclusive testing and fragmented referrals before a definitive diagnosis. Despite broad access to genomic sequencing, many patients remain undiagnosed,... Read more

Image: The BiliSeq assay detects cancer-associated genetic mutations in bile duct tissue (photo courtesy of Adobe Stock)

New Molecular Test Boosts Accuracy of Bile Duct Cancer Diagnosis

Bile duct strictures can arise from cancer or benign disease, but their location within ducts connecting the liver, gallbladder, and intestines complicates evaluation. Standard biopsy and cytology may... Read more

Adaptive PCR Platform Improves Consistency in Small-Batch NGS Workflows

PCR amplification during next-generation sequencing (NGS) library preparation can introduce variability, often requiring manual quantification and risking over-cycling artifacts. The issue is especially... Read more

First IVDR‑Certified IGH Clonality Assay Supports Diagnosis of B-Cell Malignancies

Accurate identification of clonal immunoglobulin heavy chain (IGH) gene rearrangements is central to evaluating suspected B-cell lymphoproliferative disorders, where a single B-cell clone yields a defining... Read more

Hematology

view channel

$Image: Hemex Health’s Gazelle platform is designed to rapidly separate and detect hemoglobin fractions and variants using miniaturized electrophoresis technology (photo courtesy of Hemex Health)$

Rapid Cartridge-Based Test Aims to Expand Access to Hemoglobin Disorder Diagnosis

Sickle cell disease and beta thalassemia are hemoglobin disorders that often require referral to specialized laboratories for definitive diagnosis, delaying results for patients and clinicians.... Read more

New Guidelines Aim to Improve AL Amyloidosis Diagnosis

Light chain (AL) amyloidosis is a rare, life-threatening bone marrow disorder in which abnormal amyloid proteins accumulate in organs. Approximately 3,260 people in the United States are diagnosed... Read more

Image: The new device can fit in the palm and is capable of measuring the quality of red blood cells (Photo courtesy of Xiaoyun Ding)

Fast and Easy Test Could Revolutionize Blood Transfusions

Blood transfusions are a cornerstone of modern medicine, yet red blood cells can deteriorate quietly while sitting in cold storage for weeks. Although blood units have a fixed expiration date, cells from... Read more

Automated Hemostasis System Helps Labs of All Sizes Optimize Workflow

High-volume hemostasis sections must sustain rapid turnaround while managing reruns and reflex testing. Manual tube handling and preanalytical checks can strain staff time and increase opportunities for error.... Read more

Immunology

view channel

FDA Approval Expands Use of PD-L1 Companion Diagnostic in Esophageal and GEJ Carcinomas

Esophageal and gastroesophageal junction carcinomas (GEJ) have a poor prognosis, with approximately 16,250 deaths in the United States in 2025 and a five-year relative survival of 21.9%.... Read more

Image: The findings indicate common blood tests can provide insight to tumor activity before treatment begins (photo courtesy of Adobe Stock)

Study Identifies Inflammatory Pathway Driving Immunotherapy Resistance in Bladder Cancer

Bladder cancer remains a prevalent malignancy with variable responses to immune checkpoint inhibitors. Clinicians often observe elevated C-reactive protein and interleukin-6 in affected patients, yet the... Read more

Image: Overview of the microfluidic assay for cancer-associated leukocyte adhesion profiling (Photo courtesy of Brian Choi, Seyong Kwon, Min Seok Lee, et al.,)

Microfluidic Chip Detects Cancer Recurrence from Immune Response Signals

Early identification of treatment response and relapse remains a major challenge in solid tumors, where minimal residual disease is difficult to detect with routine imaging and blood tests.... Read more

Cancer Mutation ‘Fingerprints’ to Improve Prediction of Immunotherapy Response

Cancer cells accumulate thousands of genetic mutations, but not all mutations affect tumors in the same way. Some make cancer cells more visible to the immune system, while others allow tumors to evade... Read more

Microbiology

view channel

Genomic Analysis Links Emerging Streptococcal Strains to Specific Infections

Streptococcus dysgalactiae subspecies equisimilis (SDSE) infections are increasing worldwide and include variants that may lead to severe disease. Researchers now report that whole-genome sequencing of... Read more

Image: The direct-from-urine rapid method can identify an effective antibiotic in an average of 5.85 hours (photo courtesy of Shutterstock)

Rapid Urine Test Speeds Antibiotic Selection for UTIs

Urinary tract infections are a common reason for antibiotic prescribing and have led to more than 800,000 hospital admissions across England in the past five years, according to National Health Service data.... Read more

Image: The guidance recommends easy‑to‑collect tongue swab samples and a cost‑saving sputum pooling strategy for TB and rifampicin‑resistant TB. (photo courtesy of WHO / Enric Catala Contreras)

WHO Endorses Rapid Point-of-Care Testing to Improve TB Detection

Tuberculosis (TB) remains a leading infectious killer, with more than 3,300 deaths and 29,000 new illnesses every day. Diagnostic delays and dependence on centralized laboratory networks continue to impede... Read more

Breath Analysis Approach Offers Rapid Detection of Bacterial Infection

Accurate and rapid identification of bacterial infections remains challenging in acute care, where delays can hinder timely, targeted therapy. Infectious diseases are a major cause of mortality worldwide,... Read more

Pathology

view channel

AI Tool Predicts Patient-Specific Chemotherapy Benefit in Breast Cancer

Selecting adjuvant chemotherapy for early-stage breast cancer is typically guided by recurrence risk and population-level averages rather than patient-specific benefit. However, existing clinicopathologic... Read more

Image: Study cohorts, deep learning system architecture, and performance evaluation on TAILORx-Test (Shamai G, Cohen S, Binenbaum Y et al., Lancet Oncology, 2026; . DOI: 10.1016/s1470-2045(25)00727-2)

AI-Based Pathology Model Guides Chemotherapy Decisions in Breast Cancer

Selecting adjuvant chemotherapy for early-stage breast cancer remains a difficult decision because only a subset benefits and many undergo toxicity without gain. Genomic assays can help but are costly,... Read more

Biopsy-Based Gene Test Predicts Recurrence Risk in Lung Adenocarcinoma

Lung cancer is the leading cause of cancer death, killing more people in the United States than breast, prostate, and colon cancers combined. In lung adenocarcinoma (LUAD), tumors that invade nearby blood... Read more

AI-Powered Tool to Transform Dermatopathology Workflow

Skin cancer accounts for the largest number of cancer diagnoses in the United States, placing sustained pressure on pathology services. Diagnostic interpretation can be variable for challenging melanocytic... Read more

Technology

view channel

Image: Graphical Abstract (Huiqian Hu et al., Med 7(3): 100966 (2026). DOI: 10.1016/j.medj.2025.100966)

New AI Tool Enables Rapid Treatment Selection in Pediatric Leukemia

Children with T-cell acute lymphoblastic leukemia face an aggressive disease that remains difficult to treat. Although remission rates have improved, many survivors experience long-term effects from intensive... Read more

Image: The new MultiQ-IT prototype can cool, trap, filter, and redirect over a billion ions simultaneously, dramatically improving dynamic range and signal-to-noise (Photo courtesy of Lori Chertoff/The Rockefeller University)

Breakthrough Mass Spectrometry Design Could Enable Ultra-Low Abundance Detection

Mass spectrometry is central to identifying and quantifying molecules in complex biological samples, but conventional instruments typically analyze ions sequentially, which can limit detection of rare species.... Read more

Image: Schematic illustration of the MetaRing platform for detecting paclitaxel treatment sensitivity in breast cancer (Photo courtesy of HUANG Guangyao)

Rapid Biosensor Detects Drug Sensitivity in Breast Tumors

Chemotherapy selection for breast cancer is challenged by heterogeneous tumor responses. Conventional chemosensitivity assays can be slow, require large sample volumes, and struggle with complex biological... Read more

Online Tool Supports Family Screening for Inherited Cancer Risk

Genetic test results in oncology often have implications for relatives who may share inherited cancer risk. Many health systems lack structured processes to help patients alert family members, limiting... Read more

Industry

view channel

Takara Bio USA and Hamilton Partner Partner to Automate NGS Library Preparation

Takara Bio USA, Inc. (San Jose, CA, USA), a wholly owned subsidiary of Takara Bio Inc., and Hamilton Company (Reno, NV, USA) announced a development and co-marketing agreement to deliver integrated, automated... Read more

Lunit and CellCarta Collaborate to Expand AI Pathology in CDx Development

Lunit (Seoul, South Korea), a leading provider of AI for cancer diagnostics and precision oncology, and CellCarta (Montreal, QC, Canada), a global contract research organization (CRO) laboratory serving... Read more

Integrated DNA Technologies Expands into Clinical Diagnostics

Integrated DNA Technologies (IDT; Coralville, Iowa, USA) has announced the launch of Archer FUSIONPlex-HT Dx and VARIANTPlex-HT Dx. This launch marks the company’s first in vitro diagnostic (IVD) offerings... Read more

Co-Diagnostics Agreement Expands Commercial and Distribution Reach in South Asia

Co-Diagnostics (Co-Dx; Salt Lake City, UT, USA) has signed an agreement for CoSara Diagnostics Pvt. Ltd., its Indian joint venture with Ambalal Sarabhai Enterprises Limited (Ahmedabad, India), to extend... Read more