The firm is preparing to launch a clinical trial for the AdxBladder test in the US early in 2019 and use the results to apply for 510(k) clearance with the FDA.
In a recent study in Blood, the researchers showed that a higher allelic burden after transplantation was associated with higher risk of relapse and mortality.
The financing will go toward driving adoption of the company's technology, which can distinguish bacterial infections from viral ones, and other purposes.
The firm has been placing point-of-care systems primarily in the private sector, but may have increased access once it completes WHO prequalification review.
MRM will develop immuno-MALDI mass spec assays to key cancer signaling proteins and test them in 100 breast and colorectal cancer samples provided by Exactis.
BBI has developed Morffi ™ signal enhancement technology which has the potential to enhance the sensitivity of lateral flow immunoassays. In this paper, we demonstrate the increased sensitivity that can be achieved using this new signal enhancement technology, comparing it with traditional BSA blocking in a brain natriuretic peptide assay. The results show that this proprietary technology offers a 10-fold improvement in the limit of detection over the BSA-blocked control, highlighting its potential for enhancing both current and future lateral flow tests.
Mobile phone technology has caused widespread disruption to point of care testing. Smartphone diagnostic readers can accurately scan and record the results from a wide range of rapid tests. Test results are accurate, available quickly and can be shared securely with healthcare professionals online.
Freeze-drying (lyophilization) is becoming increasingly popular with IVD test manufacturers looking to simplify assay handling and processing. Biofortuna is a leading supplier of freeze-dried tests, and has a wealth of expertise in transforming molecular diagnostic reagents into instantly soluble freeze-dried pellets. This white paper outlines the key considerations when developing a freeze-dried IVD test and discusses some of the strategies that can be used to ensure rapid, successful and cost-effective assay development.
