Downs Syndrome Test Developers Face Challenges
Several companies plan to launch non-invasive Downs syndrome tests. All will face several commercialization challenges to establish a leadership position in this space.
A new generation of non-invasive tests could offer expectant mothers a safer, earlier way to screen for birth defects such as Down syndrome. The blood-based tests eliminate the low, but existent chance of a miscarriage that can occur with the amniocentesis and chorionic villus sampling. In addition, the tests can be done as early as nine weeks post-conception, which is earlier than amniocentesis. While these are clearly advantages, numerous commercialization challenges remain for companies pinning their market penetration hopes on a single birth defect test such as Down syndrome.
Among these is the obvious growing number of competitors such as LifeCodexx, Verinata, Novartis AG/Fluidigm Corp, Sequenom planning to enter this relatively small clinical diagnostic segment. There is also the need to address other strategic issues such as existing competitors that offer comprehensive prenatal testing panels, reimbursement, emerging FDA regulations aimed at Laboratory Developed Tests (LDTs), the extra expense of performing both amniocentesis and non-invasive testing to generate outcomes-based evidence studies and others.
With the US birth rate running at just over 4 million per year of which approximately 5% (200,000) undergo amniocentesis, how many viable competitors can be supported in this market segment? Also, Down syndrome occurs in 1 out of 691 births, but other prenatal abnormalities occur in 1 in 241 births that can be detected by a multi-parameter panel approach.
For more information on genetic screening issues, the companies mentioned above and emerging FDA LDT regulations please contact your GLG representative and schedule an individual consult today.
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