Roche receives FDA Emergency Use Authorization for the LightMix Ebola Zaire rRT-PCR Test
Pleasanton, CA, USA, 29 December 2014
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has provided an Emergency Use Authorization (EUA) for the LightMix® Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as individuals traveling from West Africa. The test is used for the detection of Ebola Zaire Virus in whole blood samples using the large installed base of Roche’s LightCycler® 480 or cobas z 480 instruments.
“The LightMix® Ebola Zaire test is an easy-to-use molecular diagnostic test providing a solution for healthcare professionals to quickly detect the virus and start patient treatment as early as possible.” said Roland Diggelman COO, Roche Diagnostics Division. “As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare emergencies. The FDA’s granting of this EUA supports our commitment to healthcare professionals working to combat this deadly disease.”
The LightMix® Ebola Zaire rRT-PCR Test has also been CE marked by the test’s manufacturer, TIB MOLBIOL GmbH, and is available for use on the LightCycler® 480 or cobas z 480 instruments in markets accepting the CE mark. In addition, TIB MOLBIOL GmbH has submitted an Expression of Interest (EOI) for Emergency Assessment by the World Health Organization Prequalification of the In vitro Diagnostics Programme.
About the LightMix® Ebola Zaire rRT-PCR Test
Manufactured by TIB MOLBIOL GmbH and exclusively distributed by Roche, the LightMix® Ebola Zaire rRT-PCR Test is a one-tube duplex assay for the simultaneous, qualitative detection of Ebola Zaire Virus (detected in the West Africa outbreak in 2014) and an endogenous human house-keeping gene used as an internal control. The end-to-end process from sample preparation of whole blood to results can be achieved for 96 results in just over 3 hours. The test can also be used for smaller numbers of samples with a manual extraction processes, as well as labs using Roche’s MagNA Pure 96 instrument for high throughput automated nucleic acid extraction. The test was developed to be run on the LightCycler® 480 or the cobas z 480 qPCR instruments, allowing the response to be most effective through utilization of abroad installed instrument base.
About Emergency Use Authorization Status
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories;
- This test has been authorized only for the detection of RNA from Ebola Zaire virus (detected in the West Africa outbreak of 2014) and not for any other viruses or pathogens; and
- 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.
About TIB MOLBIOL, GmbH
Since 1990, TIB MOLBIOL has been providing high quality products used in the fields of life science research, medical diagnostics, product quality assessment and environmental analysis. Head Quartered in Berlin, Germany, TIB Molbiol has offices and production facilities in the USA, Italy, Spain and Poland. The company’s presence in several countries has facilitated the support and cooperation with its customers and increased its potential to quickly respond to critical biological threats such as SARS, Anthrax, Avian Influenza H5N1 and the novel Influenza H1N1 swine. For more information, please visit www.tib-molbiol.com
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.