Pioneering integrated systems to standardize the collection, stabilization, and purification of RNA and DNA

Preanalytical variables associated with sample collection, sample transportation, storage and RNA and/or DNA purification often reduce efficiency, add costs, and can negatively impact the accuracy and reliability of study outcomes. The PAXgene™ brand of products have been designed to standardize and integrate sample collection, stabilization and purification of nucleic acids to minimize preanalytical variations.

Product(s) Description:

1. The PAXgene™ Blood RNA System is the first product in the market for collection, storage, and transport of blood and stabilization of intracellular RNA in a closed tube and subsequent isolation and purification of intracellular RNA from whole blood for RT-PCR used in molecular diagnostic testing. The PAXgene™ Blood RNA System is the first to attain IVD status and СЄ mark for clinical molecular diagnostic testing.

When studying cellular RNA in whole blood, a major problem is the instability of the RNA profile in vitro. The copy number of individual mRNA species in whole blood can change more than 1000-fold during storage or transport at room temperature. The PAXgene Blood RNA system minimizes preanalytical variation caused by sample collection, storage, and transport conditions and enables clinicians and researchers to obtain reliable gene expression data and to find the subtle differences in gene expression profiles from blood.

The PAXgene Blood RNA System comprises two integrated components: PAXgene Blood RNA Tube and the PAXgene Blood RNA Kit. Blood samples are drawn directly into PAXgene Blood RNA Tubes via standard phlebotomy technique. These tubes contain a proprietary reagent that immediately stabilizes intracellular RNA for 3 days at 18-25oC and 5 days at 2-8oC, minimizing the ex-vivo degradation or up-regulation of RNA transcripts. The ability to eliminate freezing, batch samples, and to minimize the urgency to process samples following collection, greatly enhances lab efficiency and reduces costs. For long-term storage, freezing samples in the tube at -20oC or -70oC is recommended.
High quality RNA from the PAXgene Blood RNA Tube is subsequently purified using the PAXgene Blood RNA Kit. The overall system (Tube and Kit) is integrated for optimal performance. By offering complete preanalytical solutions from collection to purification, the system facilitates recovery of high quality RNA for accurate gene expression profiling that can enable diagnosis of disease and improve patient care.

The PAXgene Blood RNA System provides diagnostic laboratories, pharmaceutical companies, clinical research organizations, and research institutions a standardized method for sample collection and stabilization, and purification.
Market Status: in vitro Diagnostic Use (IVD/СЄ)

2. The PAXgene™ Blood DNA System standardizes blood collection and DNA purification from whole blood samples. The PAXgene Blood DNA Tubes are the first blood collection tubes dedicated for genomic DNA purification. The PAXgene Blood DNA System comprises two integrated components: PAXgene Blood DNA Tube and the PAXgene Blood DNA Kit. Blood is drawn directly into the PAXgene Blood DNA Tubes, which contain a proprietary additive that permits the Blood DNA to be stable for 14 days at room temperature or for 28 days at 2-8oC. For long-term storage, freezing samples in the tube at -70oC to -80oC is recommended. The PAXgene Blood DNA Kit is used to rapidly achieve reproducible yields of high-quality DNA. The use of the PAXgene Blood DNA System results in high yields of pure, high-molecular weight DNA that performs well in many different downstream applications.
Market Status: For Research Use Only (RUO). Not for use in diagnostic
procedures.

3. The PAXgene™ Bone Marrow RNA System is the first integrated system for collection, stabilization, transport, storage and intracellular RNA purification from bone marrow. The system provides a complete preanalytical solution by offering RNA profile stabilization at the site of collection through transportation, storage and efficient purification of high-quality RNA.

The PAXgene Bone Marrow RNA Tube immediately stabilizes the cellular RNA profile in the sample for storage at ambient, refrigerated, or frozen temperatures. The samples can be transported in the PAXgene Bone Marrow RNA Tube, with no need for dry ice or liquid nitrogen. RNA can be purified days later using the PAXgene Bone Marrow RNA Kit.
Market Status: For Research Use Only (RUO). Not for use in diagnostic
procedures.