A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

Streck Cell-Free DNA BCT® Earns U.S. FDA De Novo Clearance

What To Know

  • “We have always known that Cell-Free DNA BCT is the best tube for customers who are concerned about pre-analytical variation, but De Novo IVD status solidifies Cell-Free DNA BCT as a truly novel collection tube.
  • Cell-Free DNA BCT was the first tube on the market focusing on cell-free DNA in plasma, more than 10 years ago.

September 11, 2020

Streck Cell-Free DNA BCT received U.S. Food and Drug Administration De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay. Cell-Free DNA BCT is the first and only circulating nucleic acid first blood collection tube to be cleared for use with liquid biopsy.

“Streck is excited about this milestone for Cell-Free DNA BCT,” said Product Manager Joel Lechner. “We have always known that Cell-Free DNA BCT is the best tube for customers who are concerned about pre-analytical variation, but De Novo IVD status solidifies Cell-Free DNA BCT as a truly novel collection tube.”

Cell-Free DNA BCT was the first tube on the market focusing on cell-free DNA in plasma, more than 10 years ago. Since then, Streck has sold more than 35 million tubes worldwide, limiting preanalytical change on millions of samples for researchers around the globe. Research shows that pre-analytical variation causes up to 70% of failures in the laboratory. The tube accumulated citations in more than 100 peer-reviewed publications.

Cell-Free DNA BCT stabilizes nucleated blood cells with a unique preservative which reduces the release of cellular genomic DNA when compared to K2EDTA tubes in liquid biopsy next-generation sequencing assays. Accurate analysis of cell-free DNA can be compromised by sample handling, shipping, and processing, causing the lysis of nucleated blood cells and the subsequent release of cellular genomic DNA. By reducing the release of cellular genomic DNA, the specialized chemistry provides sample integrity. By eliminating the need for immediate plasma preparation, Cell-Free DNA BCT allows for convenient transportation from the collection site to a centralized testing location or reference laboratory for analysis.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The study is designed to assess the clinical utility and workflow benefits of Swoop® system images acquired at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy at the times specified in the labeling (before the fifth, seventh, and fourteenth infusions).
“Tom and I have more than 50 years of experience,” Harp adds. “The decision to found Polymer Medical was done after careful consideration of the landscape and market opportunity; we will raise the level of competition and quality for customers.” Polymer Medical is located in a newly refurbished plant is at 168 Thorn Ave., Orchard Park, N.Y.
The RWE Program will expand Summus Laser's Class IV Laser Therapy research to generate validated and statistically significant datasets that will be used to enhance patient care, outcomes, and to further product innovations.
Details of the session: Polaroid Therapeutics & Avery Dennison Medical: How the power of partnership brings a novel approach to antimicrobial wound dressings.
SABIC advises the project was initiated together with the dialysis department at Jessa Hospital, one of the largest non-university medical cluster in the Limburg region of Flanders, Belgium.

By using this website you agree to accept Medical Device News Magazine Privacy Policy