Detection of circulating methylated DNA for high-sensitivity cancer diagnostic and treatment planning

Case ID:
C12014
Disclosure Date:
5/3/2012

Unmet Need / Invention Novelty: Circulating tumor-associated methylated DNA is an important biomarker for early detection of cancer, risk assessment, predicting and monitoring response to therapy and early detection of relapse. Current tests designed to detect methylated tumor DNA in patient fluids such as the serum and plasma are challenged by low and fluctuating amounts of methylated tumor DNA, lack of sensitivity, and unreliable detection of target DNA quantities. There is an unmet need to develop a sensitive, reliable and quantitative method for detecting circulating methylated tumor DNA. 


Technical Details: Researchers at Johns Hopkins have developed a novel method for the detection of circulating methylated tumor DNA. The method, termed cMethDNA, is a derivative of their previously disclosed tissue-based quantitative multiplex methylation specific PCR (QM-MSP). cMethDNA can quantitatively detect low copy number tumor DNA methylation patterns in serum and plasma with high sensitivity and specificity. Proof of concepts studies demonstrated highly specific and sensitive detection of circulating methylated tumor DNA from the sera of breast cancer patients. A small prospective clinical validation study also demonstrated the capability of cMethDNA to monitor response post treatment and prognosticate outcome. 


Value Proposition:

  • Diagnostic and prognostic epigenetic biomarker detection method
  • Enables detection at low copy number
  • Highly sensitive (>90%) and specific (>96%)
  • Applicable to circulating tumor DNA or other diseases with aberrant methylation

 

Looking for Partners to: Develop & commercialize as a novel method for cancer diagnosis and optimized treatment planning. 

 

Stage of Development: Pre-Clinical

                                           

Data Availability: in vitro validation with patient sera 

 

Inventors: Saraswati Sukumar, Mary Jo Fackler, Antonio Wolff, Zoila Lopez Bujanda, Wei Wen Teo


Publication(s)/Related Technology:

Patent Information:
Title App Type Country Serial No. Patent No. File Date Issued Date Expire Date Patent Status
A QUANTITATIVE MULTIPLEX METHYLATION SPECIFIC PCR METHOD- cMethDNA, REAGENTS, AND ITS USE PCT: Patent Cooperation Treaty Japan 2015-514150   5/22/2013     Pending
A Quantitative Multiplex Methylation Specific for PCR method - cMethDNA, Reagents, and Its Use PCT: Patent Cooperation Treaty Australia 2013266341 2013266341 5/22/2013 4/18/2019 5/22/2033 Granted
QUANTITATIVE MULTIPLEX METHYLATION SPECIFIC PCR METHOD- cMethDNA, REAGENTS, AND ITS USE PCT: Patent Cooperation Treaty China 201380039009.7 ZL201380039009.7 5/22/2013 5/1/2018 5/22/2033 Granted
A Quantitative Multiplex Methylation Specific for PCR method - cMethDNA, Reagents, and Its Use PCT: Patent Cooperation Treaty Canada 2,874,035   5/22/2013     Pending
A Quantitative Multiplex Methylation Specific for PCR method - cMethDNA, Reagents, and Its Use PCT: Patent Cooperation Treaty European Patent Office 13794493.0 2852690 5/22/2013 8/26/2020 5/22/2033 Granted
A Quantitative Multiplex Methylation Specific for PCR method - cMethDNA, Reagents, and Its Use PCT: Patent Cooperation Treaty France 13794493.0 2852690 5/22/2013 8/26/2020 5/22/2033 Granted
A Quantitative Multiplex Methylation Specific for PCR method - cMethDNA, Reagents, and Its Use PCT: Patent Cooperation Treaty Germany 13794493.0 2852690 5/22/2013 8/26/2020 5/22/2033 Granted
A Quantitative Multiplex Methylation Specific for PCR method - cMethDNA, Reagents, and Its Use PCT: Patent Cooperation Treaty United Kingdom 13794493.0 2852690 5/22/2013 8/26/2020 5/22/2033 Granted
QUANTITATIVE MULTIPLEX METHYLATION SPECIFIC PCR METHOD- cMethDNA, REAGENTS, AND ITS USE PCT: Patent Cooperation Treaty United States 14/402,434 10,450,609 11/20/2014 10/22/2019 5/1/2035 Granted
QUANTITATIVE MULTIPLEX METHYLATION SPECIFIC PCR METHOD- cMethDNA, REAGENTS, AND ITS USE DIV: Divisional United States 16/601,269 10/14/2019     Pending
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For Information, Contact:
Nakisha Holder
nickki@jhu.edu
410-614-0300
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