Natera plans to launch its clinical oncology and transplantation tests next year and is hopeful that guidelines endorsing NIPT for average-risk pregnancies are imminent.
At a Thermo Fisher-sponsored workshop, two companies argued for the clinical utility of PGx LDTs as FDA prepared to issue a warning against unapproved tests.
The nucleic acid diagnostic platform they are developing doesn't require expensive optics, and it could be available as a manufacturing prototype in about a year.
The FDA cleared LabCorp's assay for quantitative determination of total cholesterol, high density lipoprotein cholesterol, triglycerides, and apolipoprotein B.
1Drop anticipates the platform will be capable of handling up to 64 clinical biomarkers, including indicators of cardiovascular diseases and many others.
A tick-borne disease working group recommends the federal government explore using new technologies and repurposing existing ones to improve diagnosis.
A tick-borne disease working group recommends the federal government explore using new technologies and repurposing existing ones to improve diagnosis.
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.
