The rise in approvals for saliva collection and diagnostic devices is driven by the increasing need for quick diagnosis of serious diseases. For instance, in January 2015, DNA Genotek, a part of OraSure Technologies, Inc., got the green light from the US Food and Drug Administration (USFDA) for their genetic Oragene Dx saliva collection test kits. These kits are designed to collect saliva, which is then used to screen for Bloom Syndrome, a genetic disorder. DNA Genotek collaborated with 23andMe, Inc. to produce these genetic Oragene Dx kits. In February 2015, the USFDA gave its approval for 23andMe, Inc. to market these genetic Oragene Dx saliva collection test kits. Moving forward, in January 2020, DNA Genotek announced FDA General Use Clearance for their Oragene family of products. Specifically, Oragene Dx is intended for the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. The growing demand for salivary diagnostics has led several companies to invest in the market, developing various products, kits, and devices for saliva collection and testing. This surge in development has, in turn, boosted the growth of the global saliva collection and diagnostic market.
The increase in approvals for devices used to collect and diagnose saliva is driven by the urgent need for quick and efficient diagnosis of serious diseases. A noteworthy example is the approval granted in January 2015 to DNA Genotek, a subsidiary of OraSure Technologies, Inc., by the US Food and Drug Administration (USFDA) for their genetic Oragene Dx saliva collection test kits. These kits are specifically designed to collect saliva samples for screening Bloom Syndrome, a genetic disorder. Collaborating with DNA Genotek, 23andMe, Inc. played a role in manufacturing these genetic Oragene Dx saliva collection test kits. Subsequently, in February 2015, the USFDA approved 23andMe, Inc.'s proposal to market these genetic Oragene Dx kits. Adding to these developments, in January 2020, DNA Genotek announced FDA General Use Clearance for their Oragene family of products, particularly the Oragene Dx, which is intended for the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. The rising demand for salivary diagnostics has prompted numerous companies to invest in the market, leading to the creation of various products, kits, and devices for saliva collection and testing. This increased activity has significantly contributed to the growth of the global saliva collection and diagnostic market.
Covered Aspects:Report Attribute/Metric | Details |
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Market Opportunities | Rising number of ailments along with increasing clinical trials by the government |
Market Dynamics | Saliva testing use in disease testing Saliva test devices uses in medical procedures |
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