veraxbiomedical产品代理
veraxbiomedical产品代理
Verax Biomedical建立在检测用于输血和移植的细胞和组织中细菌污染的独特愿景之上。认识到细菌在这些赋予生命的组织中构成了独特的感染挑战，我们意识到需要新的检测方法。虽然这些细胞材料通常会被检测是否含有病毒污染物，但细菌一直是一个长期存在的问题，迄今为止还没有得到很好的解决。与病毒不同，细菌可以在活体宿主外复制，这意味着它们可以在输血或移植前的储存期间在这些细胞基质中生长。这导致了一个独特的困境，即感染性污染物可能从采集时无法测量的低水平增长到输血或移植时的大量水平，对受体构成严重且往往致命的风险。我们的愿景是创建快速检测，在尽可能接近输血或移植时间的情况下实施，从而能够在使用前检测并从库存中清除这些受污染的材料。PGD技术的首次应用是在质量控制测试期间使用的一项测试，用于检测人类血小板中是否存在细菌污染。
该公司的第一个产品是血小板PGD测试——一种用于检测血小板中细菌污染的快速测试。
FDA Guidance
PGD Technology
7 Day Platelet Dating
Platelet PGDprime
Platelet PGD Test
Red Cell PGD Test
Cell Therapy PGD Test
Verax Biomedical is a privately held, venture backed medical products company, founded in 1999. The Company’s laboratory facilities are located in Marlborough, Massachusetts, just west of Boston.
Verax Biomedical was founded upon the singular vision of detecting bacterial contamination in cells and tissues intended for transfusion and transplantation. Recognizing that bacteria pose a unique infectious challenge in these life giving tissues, we realized that novel approaches to detection were called for. While these cellular materials are routinely tested for viral contaminants, bacteria have posed a long standing and heretofore poorly addressed challenge. Unlike viruses, bacteria can replicate outside of a living host, meaning they can grow in these cellular matrices during storage prior to transfusion or transplantation. This results in the unique dilemma of an infectious contaminant that can grow from unmeasurable low levels at the time of collection to massive levels at the time of transfusion or transplantation, posing a serious and often fatal risk to their recipient. Our vision is to create rapid tests that are practical to implement as close to the time of transfusion or transplantation as possible, thus enabling the detection and elimination of these contaminated materials from the inventory prior to their use. The first application of PGD technology is a test for use during Quality Control testing for the presence of bacterial contamination in human platelets.
The Company’s first product is the Platelet PGD Test — a rapid test for the detection of bacterial contamination in platelets.
