SML Genetree’s Ezplex SARS-CoV-2 G Kit has been listed on the FDA website as a commercial COVID test kit.
On June 29, 2020, SML Genetree’s Ezplex SARS-CoV-2 G Kit has been registered on the FDA’s official website as a commercial manufacturer(and test) that has notified the FDA of validation and intent to distribute diagnostic test kits as set forth in Section IV.C. (Link: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#testkit)
SML Genetree’s Ezplex SARS-CoV-2 G Kit is one of many SML Genetree’s products set to launch in the US market.
As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website.
About SML Genetree
SML Genetree is a leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics. SML Genetree’s tests ensure the detection of multiple targets with sensitivity, specificity, and reproducibility while delivering the utmost level of quality, throughput, and economics. SML Genetree’s committed to being a premier molecular diagnostics company and trusted partner in pharmacogenetics, diseases, genetics, and oncology. For more information, please visit us at www.smlgenetree.com
Contact Information : info@smlgenetree.com
<Related FDA References >
"As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.
The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution and conduct a recall of the test, and may take additional actions as appropriate."
SML Genetree’s Ezplex SARS-CoV-2 G Kit has been listed on the FDA website as a commercial COVID test kit.
On June 29, 2020, SML Genetree’s Ezplex SARS-CoV-2 G Kit has been registered on the FDA’s official website as a commercial manufacturer(and test) that has notified the FDA of validation and intent to distribute diagnostic test kits as set forth in Section IV.C. (Link: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#testkit)
SML Genetree’s Ezplex SARS-CoV-2 G Kit is one of many SML Genetree’s products set to launch in the US market.
As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website.
About SML Genetree
SML Genetree is a leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics. SML Genetree’s tests ensure the detection of multiple targets with sensitivity, specificity, and reproducibility while delivering the utmost level of quality, throughput, and economics. SML Genetree’s committed to being a premier molecular diagnostics company and trusted partner in pharmacogenetics, diseases, genetics, and oncology. For more information, please visit us at www.smlgenetree.com
Contact Information : info@smlgenetree.com
<Related FDA References >
"As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.
The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution and conduct a recall of the test, and may take additional actions as appropriate."