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ed number of substances, such as DNA or proteins.
Thus, it may require several patient samples and
several tests to evaluate a patient’s clinical status
or to determine the best therapy for the patient.
In contrast to current approved IVDs, NGS diagnostics can detect over three billion bases in the
human genome and may identify almost three million genetic variants in a single test. It is possible
that a single NGS test could identify multiple disease states, making it difficult for the FDA to evaluate the suitability of the test. Because an NGS
can analyze the whole genome, it is not necessary to know what variant you are looking
for. The FDA has issued a white paper regarding NGS diagnostics and held a public workshop in February 2015 to discuss the regulatory paths forward. The FDA has approved
one NGS system based upon demonstrating
analytical capability and reliability in detecting a subset of variants in the genome. This
approach is discussed in the white paper and
is a possible way to prove reliability and capability. In the white paper the FDA asked 10
basic questions to help frame the discussion
at the workshop to obtain a clearer picture
of what is a fair and reasonable regulatory
requirement.
Drug advances
Personalized medicine has the potential to be
the biggest advance in health in many decades.
To fully realize its promise will require shifting the paradigm as to how we define quality,
efficacy, and safety, for both personalized drug
therapies and their companion diagnostics.
The FDA is continuing to refine its position
on Companion Diagnostics and is working
on more detailed guidance. But the agency
must consider the broader implications to
Laboratory Derived Tests (LDTs) within the
guidance. Wall Street has bet heavily on this
particular sector of biotech, creating some of
the largest IPOs of 2014 and 2015. Whether
the FDA and industry can navigate this complex relationship between performance, measurement, and safety will determine the likelihood of its realization.
References
1. Human Genome Project: http://web.ornl.
gov/sci/techresources/Human_Genome/
index.shtml
2. http://www.fda.gov/down-loads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM262327.pdf
Bikash Chatterjee, President and Chief Science
Officer of Pharmatech Associates, has been involved in
the biopharmaceutical, pharmaceutical, medical device,
and diagnostics industry for over 30 years. His expertise
includes site selection, project management, design, and
validation of facilities for U.S. and European regulatory
requirements.
