Development of Diagnostic Tests for Targeted Therapies Faces Multiple Challenges

Targeted therapies are treatments aimed at specific biomarkers, such as genetic mutations, or overexpressed proteins. Tests that detect the targeted biomarker are needed to determine whether a patient would benefit from the treatment. The FDA offers an approval pathway for such tests, so-called “companion diagnostics” (CoDx), which requires that the test be evaluated alongside the drug in clinical trials. However, testing laboratories can also develop their own tests. These “laboratory-developed tests” (LDTs) are not currently regulated by the FDA. Development of LDTs is therefore much cheaper and faster (making CoDx comparatively less economically viable), but provides less evidence that these test are indeed effective. Moreover, LDTs can be designed to test for many different biomarkers, thus making more efficient use of limited biopsy tissue, while CoDx usually only test for the one biomarker relevant for their companion drug. A recent article calls for test developers, pharmaceutical companies, insurers, and the FDA to collaborate in resolving these issues.


Development of Diagnostic Tests for Targeted Therapies Faces Multiple Challenges

Targeted therapies are treatments aimed at specific biomarkers, such as genetic mutations, or overexpressed proteins. Tests that detect the targeted biomarker are needed to determine whether a patient would benefit from the treatment. The FDA offers an approval pathway for such tests, so-called “companion diagnostics” (CoDx), which requires that the test be evaluated alongside the drug in clinical trials. However, testing laboratories can also develop their own tests. These “laboratory-developed tests” (LDTs) are not currently regulated by the FDA. Development of LDTs is therefore much cheaper and faster (making CoDx comparatively less economically viable), but provides less evidence that these test are indeed effective. Moreover, LDTs can be designed to test for many different biomarkers, thus making more efficient use of limited biopsy tissue, while CoDx usually only test for the one biomarker relevant for their companion drug. A recent article calls for test developers, pharmaceutical companies, insurers, and the FDA to collaborate in resolving these issues.


Development of Diagnostic Tests for Targeted Therapies Faces Multiple Challenges

Targeted therapies are treatments aimed at specific biomarkers, such as genetic mutations, or overexpressed proteins. Tests that detect the targeted biomarker are needed to determine whether a patient would benefit from the treatment. The FDA offers an approval pathway for such tests, so-called “companion diagnostics” (CoDx), which requires that the test be evaluated alongside the drug in clinical trials. However, testing laboratories can also develop their own tests. These “laboratory-developed tests” (LDTs) are not currently regulated by the FDA. Development of LDTs is therefore much cheaper and faster (making CoDx comparatively less economically viable), but provides less evidence that these test are indeed effective. Moreover, LDTs can be designed to test for many different biomarkers, thus making more efficient use of limited biopsy tissue, while CoDx usually only test for the one biomarker relevant for their companion drug. A recent article calls for test developers, pharmaceutical companies, insurers, and the FDA to collaborate in resolving these issues.


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Not Enough Cancer Patients Enroll in Clinical Trials

Around 10% of mid- and late-stage clinical trials of cancer treatments end prematurely because not enough patients enroll, a recent analysis shows. This lack of participants slows the development of new cancer medications and wastes considerable amounts of money invested in these trials. The authors of the analysis hope to focus attention on possible reasons why too few patients enroll in clinical trials. Doctors may not always encourage their patients enough to participate, and some insurance plans do not cover the costs associated with clinical trials. Patients may also hesitate because they fear receiving only a placebo instead of treatment. However, in modern clinical trials, new cancer drugs are tested against the current standard therapy, so that all participants receive treatment.


Radiation from Medical Imaging May Increase Cancer Rates

Medical imaging techniques that use high doses of radiation, including computed tomography (CT) scans, play an important role in modern medicine, including cancer screening. However, these procedures may themselves increase the incidence of cancer. Radiation exposure from medical imaging in the U.S. has increased more than sixfold between the 1980s and 2006. Several studies have linked multiple CT scans to increased cancer risk. Moreover, there are no official guidelines on the correct radiation doses for different medical imaging techniques, meaning that doses at one hospital may be up to 50 times higher than at another. Clear standards are needed to ensure that high-radiation imaging techniques are only used when clearly medically necessary and that the lowest feasible radiation doses are employed.


Radiation from Medical Imaging May Increase Cancer Rates

Medical imaging techniques that use high doses of radiation, including computed tomography (CT) scans, play an important role in modern medicine, including cancer screening. However, these procedures may themselves increase the incidence of cancer. Radiation exposure from medical imaging in the U.S. has increased more than sixfold between the 1980s and 2006. Several studies have linked multiple CT scans to increased cancer risk. Moreover, there are no official guidelines on the correct radiation doses for different medical imaging techniques, meaning that doses at one hospital may be up to 50 times higher than at another. Clear standards are needed to ensure that high-radiation imaging techniques are only used when clearly medically necessary and that the lowest feasible radiation doses are employed.


Radiation from Medical Imaging May Increase Cancer Rates

Medical imaging techniques that use high doses of radiation, including computed tomography (CT) scans, play an important role in modern medicine, including cancer screening. However, these procedures may themselves increase the incidence of cancer. Radiation exposure from medical imaging in the U.S. has increased more than sixfold between the 1980s and 2006. Several studies have linked multiple CT scans to increased cancer risk. Moreover, there are no official guidelines on the correct radiation doses for different medical imaging techniques, meaning that doses at one hospital may be up to 50 times higher than at another. Clear standards are needed to ensure that high-radiation imaging techniques are only used when clearly medically necessary and that the lowest feasible radiation doses are employed.