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MPS-4 Data Details

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MPS-4 Increase the number of safe and effective medical products – diagnostics, drugs and biologics - associated with predictive biomarkers

About the Data

Description of the data source, numerator, denominator, survey questions, and other relevant details about the national estimate.

Data Source: 
Releasable Pre-Market Approval (PMA) database
List of Cleared and Approved Companion Diagnostic Devices (In Vivo and Imaging tools)
Changed Since the Healthy People 2020 Launch: 
Baseline (Year): 
35 (2014)
Target-Setting Method: 
10 percent improvement

Number of safe and effective medical products that are associated with predictive biomarkers

Comparable Healthy People 2010 Objective: 
Not applicable
Data Collection Frequency: 
Methodology Notes: 

    Personalized medicine is the tailoring of medical treatment to individuals during all stages of care, including prevention, diagnosis, treatment, and follow-up, the goal being to predict who will respond to a medical therapy or who will suffer ill effects. Personalized medicine generally involves the use of two medical products: a diagnostic device, which includes predictive biomarkers, and a therapeutic device. A diagnostic device is used to predict an individual’s response to a specific therapeutic device. The success of personalized medicine depends on the development of accurate and reliable diagnostics and, in some cases, on the identification of predictive biomarkers. A predictive biomarker is used to identify if a given patient is likely to respond to a treatment intervention in a particular way. This indicator focuses on diagnostic and therapeutic devices – safe and effective medical products – that are associated with predictive biomarkers.

    One example of a medical product associated with a predictive biomarker is for targeted cancer therapy. In August 2011, FDA simultaneously approved a medical product, a drug called vemurafenib (Zelboraf), along with its diagnostic test, the Cobas 4800 BRAF V600E mutation test, for use in treating metastatic or inoperable melanoma. Metastatic melanoma is a highly aggressive form of skin cancer with a 5-year survival rate of only 15 percent. Vemurafenib works by inhibiting the BRAF V600E mutation that is found in approximately half of melanoma patients. Melanomas that lack the mutation are not inhibited by the vemurafenib treatment. The BRAF V600E mutation test helps doctors predict the patients who are more likely to benefit from the vemurafenib treatment, and select a different treatment for those whom the vemurafenib treatment may have no effect.

    Data from the Releasable Pre-Market Approval (PMA) and Drugs@FDA database are extracted to create the “List of Companion Diagnostic Devices: In vitro and Imaging Tools.” This list provides information on the drug trade name, generic name, New Drug Application (NDA) and Biologic License Application (BLA) approvals, device trade name, PMA, 510(k) device manufacturer, and Intended Use (IU)/Indications for Use (IFU). Each entry in this list is reviewed to determine the number of medical products and companion diagnostics that provide information essential for the safe and effective use of a corresponding therapeutic product associated with a predictive biomarker.

Revision History

Any change to the objective text, baseline, target, target-setting method or data source since the Healthy People 2020 launch.

Description of Changes Since the Healthy People 2020 Launch: 
In 2014, MPS-4 became a measurable objective. The objective title was changed from "Increase the USE of …" to "Increase the NUMBER of safe and effective medical products that are associated with predictive biomarkers." The baseline is "15 safe and effective medical products were associated with predictive biomarkers through 2010." A target was not set for this objective because historical data are not available. In 2017, the objective moved from informational to measurable with a target. The baseline and baseline year was revised. The baseline changed from 15 in 2010 to 35 in 2014.


Additional resources about the objective

  1. FDA. Companion Diagnostic Devices (In Vitro and Imaging Tools) Database. Silver Spring, MD. Last accessed, October 24, 2014.
  2. FDA. Drugs@FDA Database. Silver Spring, MD. Last accessed, October 24, 2014.
  3. FDA. Premarket Approval (PMA) Database. Silver Spring, MD. Last accessed, October 24, 2014.