The Massachusetts Institute of Technology spinout has created a new class of activity sensors that query the body and report back clinically relevant information.
The mass spectrometry-based tests measure the level of five proteins in patient serum to assess cholesterol efflux capacity and risk of coronary artery disease.
The firm is seeking damages and various injunctions, citing 11 different counts of fraud, breach of contract, tortious interference, and unfair competition.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
At the Business in Personalized Medicine Summit last week, the company also said it has generated promising data from a pilot study for early detection of lung cancer.
The GenoCTC isolation kit isolates epithelial cell adhesion molecule-positive cells from liquid biopsies and was cleared as a reagent for an IVD device.
The amicus briefs challenge the method in which HHS collected data to establish market-based Medicare prices and found flaws in a district court decision dismissing the case.
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.
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.
Clinical laboratories are increasingly adopting molecular assays as an alternative to the tedious, time-consuming stool cultures that have long been the mainstay for testing patients who might have infectious diarrhea or conditions such as Salmonella or Campylobacter. With an estimated 1.7 billion cases of childhood diarrheal disease occurring annually around the world, this is a significant advance for gastroenteritis testing.
