The CE mark allows Biocept to commercialise the approved products across the European Union and other CE Mark geographies
US-based molecular oncology diagnostics company Biocept has secured Conformité Européene (CE) IVD Marks and rolled out its CEE-Sure Blood Collection Tube and CEE-Sure Sample Collection Shipping Kit in Europe.
The oncology diagnostics firm said that its CEE-Sure products are designed to collect and transport blood and other liquid biopsy specimens.
The receipt of CE Marks confirms the compliance of its products with the requirements of the European In-Vitro Diagnostic Devices Directive.
In addition, the CE mark allows the company to commercialise the approved products across the European Union and other CE Mark geographies.
Biocept’s CEE-Sure Blood Collection Tube and Sample Collection Shipping Kits
The CEE-Sure Blood Collection Tube has been designed to transport the liquid biopsy samples intactly from the clinic at room temperature to the central laboratories where molecular and cellular analyses were conducted.
The CEE-Sure technology allows the preservation of CTCs, ctDNA or ctRNA collected from the patient in the same tube, and prevents clogging of microfluidics devices using a patented media that inhibits cell clumping.
The technology is also capable of preserving circulating ctDNA or ctRNA for advanced molecular testing platforms and application including next generation sequencing (NGS), non-invasive prenatal testing and detection of gene mutations in cancer.
The company said that its CEE-Sure Blood Collection Tube is useful in collecting and transporting several types of specimen including blood, cerebrospinal fluid, sputum, and fluid obtained from pleural effusion.
In addition, the collection tubes avoid the need for pre-shipment specimen processing, refrigeration during shipping, or centrifugation upon receipt, to eliminate barriers to the adoption of liquid biopsy.
The CEE-Sure Sample Collection and Shipping Kits are designed to contain the CEE-Sure Blood Collection Tubes along with other components and instructions for collecting and shipping the blood samples.
Biocept president and CEO Michael Nall said: “We are excited to announce this milestone, that our proprietary specimen collection tubes and shipping kits are now commercially available in Europe, consistent with our quest to brand Biocept globally as a leading technology provider in the liquid biopsy segment.
“Our internally-developed and patented tube technology offers the ability to preserve and ship specimens containing CTCs, ctDNA, and ctRNA for use in oncology and prenatal diagnostics, as well as other molecular testing, throughout the world without refrigeration or special handling. We believe that these advantages will enable more patients to benefit from the use of liquid biopsy.”