Genetic
testing is oftenly performed as a part of genetic consultation. These
tests are performed either on blood, skin, hair, or amniotic fluid.
Genetic tests include the analysis of an individual’s genetic
material (DNA or RNA), in order to determine the susceptibility to
certain abnormalities or specific disorders or to identify the
genetic differences (variants) if any. Currently, genetic tests have
developed to a larger extent that in turn facilitates the doctors to
detect any defective or missing genes. Specific genetic tests are
designed for specific disorders to be identified. There are several
instances where a doctor may recommend genetic testing or counseling,
for example, if a couple’s first child suffers from a severe birth
defect, or if a woman has more than two miscarriages, or a woman
who is pregnant at or after age 35.
Genetic
consultation is crucial as it helps determination of a genetic or
inherited disorder before giving birth to a child and hence avoids
the serious birth defects. Diagnostic, pharmacogenetics, prenatal
testing, preimplantation testing, presymptomatic and predictive
testing and newborn screening constitute several types of genetic
tests performed for various reasons. These tests involve the use of
reagents of high purity and quality. These are essential in order to
ensure accurate results of the tests. Any compromise in the quality
and composition of the reagent results in deviation from accurate
results and can be misleading.
There
is an extensive usage of reagents at each and every step of the
process such as from deoxyribonucleic acid (DNA) extraction to
isolation and purification. With the rapid pace of technological
advances in the field of genomics, more and more genetic tests are
being implemented in several laboratories across the globe. This is
leading to marketing of the genetic tests without proper regulation.
Genetic testing finds application in various areas such as
determination of genetic disorders, paternity testing, forensics and
others.
Three
federal agencies namely, Center for Medicare and Medicaid services
(CMS), Food and Drug Administration (FDA) and Federal Trade
Commission (FTC) play a very significant role in regulating genetic
tests. CMS regulates the clinical laboratories and confirms the
quality of the lab processes implemented. FDA regulates the marketing
of various test kits possessing reagents while FTC puts a check on
misleading and false advertising. On July 31, 2014, FDA announced
that it would release draft guidelines to regulate laboratory
developed tests (LDTs) owing to the increased mismatch between the
tests performed in commercial laboratories and the physicians ordered
tests.
Genetic
tests has the capability to revolutionize the clinical practice
however, increased adoption of these tests depends on coverage and
reimbursement provided by several insurance providers. If these
insurance providers are not willing to pay for the tests, it might
result in stagnant growth of the market. There is very limited
information available on the reimbursement decisions about genetic
testing. The genetic test kits include the standard sample, distilled
water, buffer solutions and other extraction and isolation reagents.
The usage of these reagent kits is prominent in developed regions
such as North America and Europe as compared to Asian countries such
as India and China.
The
market for genetic testing reagent kits can be analyzed by various
geographies such as Europe, North America, Asia Pacific and Rest of
the World. Furthermore, this market can be analyzed by various
application areas such as new born screening, prenatal testing,
forensics and paternity testing. Factors such as regulatory and
reimbursement policies govern the commercialization and marketing of
genetic testing reagent kits. The major factors favoring the market
growth are continuous technological advances, increasing acceptance
of genetic consultation and counseling. On other hand factors such as
high cost of the procedures and lack of reimbursement and medical
coverage restrain the market growth. Danaher Corporation,
Sigma-Aldrich Co., LLC. ThermoFisher Scientific, Hologic, Inc., Roche
Diagnostics and Abbott Laboratories are some of the key players
operating in this market.
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