Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
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 3,300+ scientific posters on ePosters
  • More Than 4,900+ 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.

Related Content

Predictive Biosciences Announces Partnership with ARUP Laboratories
Predictive Biosciences today announced a partnership with ARUP Laboratories to offer the company’s molecular diagnostic bladder cancer tests to ARUP’s national network of clients.
Wednesday, April 03, 2013
Predictive Biosciences Appoints Dr. Angelo De Marzo to Leadership Team
Angelo M. De Marzo, M.D., Ph.D., arrives with an extensive background in prostate cancer research and urological pathology practice. Dr. De Marzo has been a faculty member at The Johns Hopkins University (JHU) School of Medicine since 1998.
Friday, January 06, 2012
Scientific News
Breakthrough Flu Vaccine Inhibited by Pre-existing Antibodies
Universal truths – how existing antibodies are sabotaging the most promising new human flu vaccines.
Researchers Develop Software That Could Facilitate Drug Development
AptaTRACE can identify aptamers, potentially speed drug advancement.
Gene Therapy for Metabolic Liver Diseases
Researchers have tested gene therapy in pigs from hereditary tyrosinemia type 1, with corrected liver cells being transplanted into the diseased liver.
Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
New Medication Shows Promise Against Liver Fibrosis in Animal Studies
Liver fibrosis is a gradual scarring of the liver that puts people at risk for progressive liver disease and liver failure.
Raw Eggs Deemed Safe to Eat
A report published today by the Advisory Committee on the Microbiological Safety of Food (ACMSF) into egg safety has shown a major reduction in the risk from salmonella in UK eggs.
Monitoring TTX Toxin in Shellfish
In a number of small studies, mussels and oysters from the eastern and northern part of the Oosterschelde in Holland were found to contain tetrodotoxin (TTX).
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Gene-Editing 'Toolbox' Targets Multiple Genes Simultaneously
Researchers have designed a system that modifies, or edits, multiple genes in a genome at once while minimising unintentional effects.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!