Date: 2014-12-04
Type of information: Distribution agreement
Compound: RealStar® Ebolavirus RT-PCR Kit 1.0
Company: Qiagen (The Netherlands) altona Diagnostics (Germany)
Therapeutic area: Infectious diseases - Diagnostic
Type agreement: distribution
Action mechanism: The diagnostic kit, developed and manufactured by altona Diagnostics GmbH, is a reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from all known strains of Ebolaviruses, including the Zaire strain driving the current Ebola epidemic in West Africa.
Disease: Ebola fever
Details: * On December 04, 2014, Qiagen announced it will offer global distribution of the altona Diagnostics RealStar® Ebolavirus RT-PCR Kit 1.0 after the FDA amended, on November 26, 2014 to permit authorized distribution and use in US and certain non-US laboratories, an Emergency Use Authorization (EUA) originally issued on November 10, 2014, for this kit. Qiagen has agreed to distribute the RealStar® Ebolavirus RT-PCR Kit 1.0 in addition to altona’s already CE-IVD marked test, the RealStar® Filovirus RT-PCR Kit, which is for both Ebola and Marburg viruses and does not fall under the EUA. The RealStar® Ebolavirus kit is authorized for emergency use on specified instruments in plasma from individuals with signs and symptoms of Ebolavirus infection in conjunction with clinical and epidemiological risk factors. As authorized by the FDA under EUA, the test has not been FDA cleared or approved. It has been authorized by the FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories and only for the detection – not differentiation – of RNA from Ebolaviruses (such as Zaire ebolavirus, (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014], Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus) and not for any other viruses or pathogens. Furthermore, this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Qiagen’s agreement with altona Diagnostics to distribute the FDA-authorized RealStar® Ebolavirus RT-PCR Kit 1.0 expands an existing collaboration between the two companies which was signed in the third quarter of 2014. Under the earlier agreement, Qiagen is also distributing the RealStar® Filovirus RT-PCR Kit, which does not fall under the EUA, outside the United States. This highly sensitive test for Filoviruses (Ebola and Marburg) that is CE-IVD marked for use on QIAGEN instruments and with QIAGEN sample technologies outside the United States is also compatible with other widely used detection platforms present in many laboratories, helping to avoid the need for new equipment and additional trainings.
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