Corporate Banner
Satellite Banner
Next Gen Sequencing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Predictive Biosciences Announces Next-Generation Sequencing Assay for p53

Published: Friday, December 07, 2012
Last Updated: Friday, December 07, 2012
Bookmark and Share
Predictive Biosciences announced it has developed a new next-generation sequencing (NGS) assay for the TP53 gene (encoding the p53 protein) that will enhance the clinical performance of its bladder cancer assay.

The new CertNDx(TM) Bladder Cancer Assay incorporating TP53 is expected to be commercially available in early 2013.

Predictive's next-generation sequencing assay for TP53 can detect 133 different mutations previously identified in bladder cancers. A research study conducted on 200 control samples and 36 cancers, incorporating TP53 sequence analysis into the existing assay, demonstrated an improvement over the previously published test by increasing sensitivity across bladder cancer pathways while retaining very high specificity and high Positive Predictive Value (PPV). The performance of this assay will also be validated in a large, prospective clinical trial to be completed in the first quarter of 2013.

The CertNDx test now fully incorporates the different pathways of bladder cancer. One pathway consists of primarily low-grade cancers, which are characterized predominantly by mutations in FGFR3. A second pathway consists of mostly high-grade cancers or carcinoma in situ lesions, which typically have mutations in TP53. These TP53 mutant tumors are more likely to be associated with a more aggressive clinical course and a very high likelihood of progression to a life threatening disease.

"By combining p53 with our current FGFR3 assay, we can provide excellent detection for both pathways, covering all stages and grades of bladder cancer," said Anthony P. Shuber, Chief Technology Officer. "In addition to incorporating p53 into the existing CertNDx assay, we are developing a version of the assay which integrates all of the CertNDx biomarkers in a format which can be run on any NGS platform, making it ready for in vitro diagnostic kit development."

Marc Schneebaum, Chief Executive Officer, added, "We are very excited that p53 further optimizes the performance of our NGS-based CertNDx test. This evolution of our test provides another compelling example of how Predictive's unique diagnostic approach and portfolio of clinically validated biomarkers leverages the ongoing innovation in NGS platform technology to add true clinical value."


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Monovar Drills Down Into Cancer Genome
Rice, MD Anderson develop program to ID mutations in single cancer cells.
Five New Breast Cancer Genes Found
Discovery of mutations paves the way for personalised treatment of breast cancer.
New Neurodevelopmental Syndrome Identified
Study pinpoints underlying genetic mutations, raising hopes for targeted therapies.
Uncovering Hidden Genomic Alterations that Drive Cancers
Tested on large tumor genomics database, REVEALER method allows researchers to connect genomics to cell function.
Gene Behind Rare Childhood Syndrome Identified
Online activism by one patient’s mother spurred research collaboration which led to the identification of a new genetic syndrome.
Resilience Project Identifies Rare Unaffected Individuals
Researchers from Mount Sinai and Sage Bionetworks report analysis of nearly 600,000 genomes for resilience project.
Rare DNA Will Have Nowhere To Hide
Two National Institutes of Health grants back Rice University effort to develop new diagnostics.
Virus Causing Tilapia Die-Offs Identified
Discovery of the virus causing Tilapia die-offs in Israel and Ecuador points the way to protecting a fish that feeds multitudes.
Children With Cancer To Get New Gene Test
Pilot study will sequence 81 cancer genes in children’s tumours to help personalise cancer treatment.
How The Bat Got Its Wings
Finding may provide clues to human limb development and malformations.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!