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Posts Tagged ‘biomarker/companion diagnostics’


FDA approves blood-based colorectal screen

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

FDA Clears First Blood-Based Colorectal Cancer Screening Test.
Lab Soft News by Bruce Friedman
https://www.linkedin.com/pulse/fda-clears-first-blood-based-colorectal-cancer-screening-joseph-colao

In the upcoming months, there surely will be an increasing number of blood-based genomic cancer tests approved by the FDA. This specific test market is just too attractive. In a recent note, I discussed some of these testing initiatives from the perspective of companion diagnostics (see: An Expanding Definition for Companion Diagnostics). This form of testing in used in collaboration with cancer therapy to select the right drug or monitor the effectiveness of drug therapy. Obviously and of equal importance are biomarkers intended for cancer screening. A recent article reported that the FDA has cleared the first blood-based screening test for colorectal cancer (see: FDA Clears First Blood-Based Colorectal Cancer Screening Test), Below is an excerpt from it:

The first blood-based colorectal cancer (CRC) screening test, Epi proColon...has been approved by the US Food and Drug Administration (FDA)….The Epi proColon test is a qualitative in vitro diagnostic test for detecting methylated Septin9 DNA, which has been associated with the occurrence of CRC, in plasma obtained from whole-blood specimens. It is indicated for use in average-risk patients who have chosen not to undergo other screening methods, such as colonoscopy or stool-based tests.The test was recommended for FDA approval in 2014 by the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee, but some of the experts were not convinced….The agency approved the Epi proColon test for CRC screening in average-risk patients (as defined by current screening guidelines) who choose not to be screened by colonoscopy or a stool-based FIT [fecal immunochemical test for occult blood in the stool].The Epi proColon blood test for CRC screening can be performed during routine office visits. It requires no dietary restrictions or alterations in medication use. The blood sample is analyzed by a local or regional diagnostic laboratory….The company will initiate a postapproval study to show the long-term benefit of blood-based CRC screening using Epi proColon, as required by the FDA.

Here’s more information about Septin9 DNA (see: Plasma methylated septin 9: a colorectal cancer screening marker):

The biomarker septin 9 has been found to be hypermethylated in nearly 100% of tissue neoplasia specimens and detected in circulating DNA fractions of CRC patients. A commercially available assay for septin 9 has been developed with moderate sensitivity (∼70%) and specificity (∼90%) and a second generation assay, Epi proColon 2.0 (Epigenomics AG), shows increased sensitivity (∼92%).The performance of the assay proved to be independent of tumor site and reaches a high sensitivity of 77%, even in early cancer stages (I and II). Furthermore, septin 9 was recently used in follow-up studies for detection of early recurrence of CRC. 

There is clearly a need for a blood-based biomarker for colorectal cancer screening. Patients tend to dislike the home stool collection that is required for fecal immunochemical tests for occult blood in the stool (FIT). Moreover, testing for blood in the stool offers a somewhat crude substitute for the identification of reliable cancer biomarkers in the blood. It must be noted, however, that some of the FDA experts in 2014 were not convinced that the septic 9 biomarker offered advantages over FIT.

I am not sure that septin 9 will be the final and most efficient biomarker for CRC but I am sure of two things. The first is that there will eventually be a high-specificity, high-sensitivity blood test for CRC. The second is that probably tens of billions of dollars would be saved by the elimination of screening colonoscopies for CRC by such a test. I found an article dating way back to 2002 about the number of screening endoscopies performed in the U.S. but the numbers are sill impressive  (see: How many endoscopies are performed for colorectal cancer screening?) Here is a quote from it: “Approximately 2.8 million flexible sigmoidoscopes and 14.2 million colonoscopies were estimated to have been performed in 2002.” Needless to say, many gastroenterologists and radiologists may be hoping that such a lab test does not reach the market soon.

Septin-9 is a protein that in humans is encoded by the SEPT9 gene.[1][2][3

SEPT9 has been shown to interact with SEPT2[4] and SEPT7.[4]

Along with AHNAK, eIF4E and S100A11, SEPT9 has been shown to be essential for pseudopod protrusion, tumor cell migration and invasion.[5]

The v2 region of the SEPT9 promoter has been shown to be methylated in colorectal cancer tissue compared with normal colonic mucosa.[6] Using highly sensitive real time PCR assays, methylated SEPT9 was detected in the blood of colorectal cancer patients. This alternate methylation pattern in cancer samples is suggestive of an aberrant activation or repression of the gene compared to normal tissue samples.[7][8]

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New Access to and Global Reach Availability to the New website

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UPDATED on 10/12/2016 

To contact New Medicine, request a no-obligation 2-week access to nm|OK or to order nm|OK, please visit http://www.newmedinc.com.

Oncology Drug Development and Personalized Medicine Knowledgebase

  • Comprehensive resource covering all aspects of the global oncology sector
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  • Over 1,180 molecular markers identified as diagnostic and treatment targets
  • Thousands of affiliations/licensing agreements/spin-offs involving commercial entities and most major institutions worldwide

LAKE FOREST, Calif., April 12, 2016 /PRNewswire/ — New Medicine (http://www.newmedinc.com) has launched New Medicine’s Oncology KnowledgeBASE (http://www.nmok.net), a highly disciplined relational database that provides a comprehensive view of the global oncology sector.   

nm|OK New Drugs and Marketed Drugs profiles
nm|OK provides detailed profiles of over 5,000 distinct drugs/in vivo imaging agents in development and on the market by:

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Past descriptions:

  • Oncology KnowledgeBASE and

  • Future Oncology Newsletter

 

 

Oncology KnowledgeBASE

New Medicine’s Oncology KnowledgeBASE (nm|OK) provides a comprehensive view of the status of the global oncology drug development and personalized medicine sector in terms of:

  • companies developing and marketing therapeutic/in vivo imaging agents and/or in vitro diagnostics
  • institutions/non-profits with affiliations/agreements in this sector
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Sample Company records >
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Nm|OK New Drugs and Marketed Drugs profiles >

nm|OK provides detailed profiles of over 5,000 distinct drugs/in vivo imaging agents in development and on the market by

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  • generic name/brand name/other designation
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  • cancer indications; over 100 indications
  • clinical indications; hundreds of indications
  • administration route
  • molecular target
  • biomarker/companion diagnostics
  • delivery technology
  • development status
  • clinical development by phase and status
  • clinical history, including trial protocols, interim and final results
  • sales history (when available)

nm|OK Company profiles >

nm|OK profiles over 2500 companies in the oncology space in terms of

  • history
  • management
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  • affiliations/collaborations/licenses
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nm|OK Targets in Oncology Profiles >

nm|OK profiles over 1,000 molecular targets implicated in cancer and its treatment in terms of

  • cancer indication
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Future Oncology

Future Oncology

Free_IconFrom June 1995 to August 2008, New Medicine published Future Oncology, a comprehensive analytical newsletter tracking the evolution of global drug development in oncology.  Despite of the incredible amount of effort in this area in the last 20 years, we currently face the same problems that were being tackled then, namely a lack of understanding as to the origins and mechanisms of malignancy.  Despite the incredible global effort in this area and the remarkable scientific breakthroughs in biology and medicine, advanced cancer has remained an incurable disease.  However, although cancer remains undefeated, treatment of this disease has created a huge global market comprised of drugs that, with few exceptions, provide marginal relief at a very high cost.  Because the origins of this disease have remained obscure, there have been numerous approaches popularized at different times as to its treatment.  Future Oncology has tracked these developments over time, from the rise of immunotherapy in the late 1990s to the subsequent discovery of oncogenes and tumor suppressors that shifted the emphasis from the labor intensive immunotherapy and gene transfer approaches to the relative simplicity of the production and delivery of monoclonal antibodies (MAb), oligonucleotides and small molecule drugs.  Although some major advances have led to significant survival gains of patients with hematologic malignancies, they have not produced the same results in the treatment of metastatic solid tumors.

In the meantime, the competitive landscape underwent a major transformation. The archives follow the progress or demise of hundreds of commercial entities globally and hundreds of drugs, among some of the most successful to date as well some noted failures.  The passage of time has produced many surprising winners and a few unexpected losers.  Celgene, an unknown small company in 1995, has become a leading biotech juggernaut.  Rituximab, a relatively low tech transformational therapy for the treatment of hematologic malignancies, developed by the small company Idec and approved in the USA in November 1997, may be considered the most successful anticancer agent to date both for significantly extending survival and for generating billions in sales for its developers and marketers.  Since its first approval in 1995, Rituxan’s total global revenues exceeded $65 billion, including sales in the immunology sector beginning in FY 2013.  Imatinib, launched in 2001, ushered the era of personalized medicine.  Avastin, the first targeted treatment for solid tumors launched by Genentech in 2004, garnered over $60 billion in global revenues to date.

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