Tecan provides high-throughput molecular diagnostic solution for FDA- approved Procleix™ HIV-1/HCV assay
- Tecan’s expertise in laboratory automation complements Chiron’s new - FDA-approved viral testing assay for molecular diagnostics Semi-automated systems check for early stage hepatitis C and human immunodeficiency virus type 1 infections in donated whole blood - Several hundred units expected to be installed worldwide
Zurich, Switzerland, 27 August 2002 – Tecan, a leading player in the Life Science supply industry, has entered into an agreement with Chiron Corporation to include the FDA-approved Procleix™ HIV-1/HCV assay on its high-throughput Genesis platform. This alliance makes possible large-scale testing of the blood supply with Chiron’s new FDA-approved viral testing kit.
The Procleix™ assay is a nucleic acid amplification test (NAT) designed to detect the presence of all known human immunodeficiency virus 1 (HIV-1) subtypes and hepatitis C virus (HCV) genotypes in whole blood during the very early stages of infection. In the early stages of infection, HIV-1 and HCV viruses are difficult to detect by conventional immunodiagnostic screening technologies. This is due to the delay in formation of detectable antibodies by the body after exposure to these infectious organisms.
“This on-going collaboration enables us to provide a blood testing system that exploits the advantages of Chiron’s early-stage viral test and Tecan’s expertise in laboratory automation,” commented Joe Kaelin, Head of Clinical Diagnostics at Tecan. ”Very few options are available on the market for automated testing of HIV and HCV viruses. We are already seeing the significant benefits that this reliable and highly accurate high- throughput system is bringing to those involved in ensuring blood safety worldwide.”
The Procleix™ HIV-1/HCV assay was developed by Gen-Probe, Inc. in collaboration with Chiron Corporation. In the United States, the Procleix system has been used to screen more than 20 million blood donations under an Investigational New Drug (IND) protocol by the American Red Cross, America’s Blood Centers Affiliates, the Association of Independent Blood Centers and the US Army. The Biologics License Application for the HIV-1/HCV assay was recently approved by the US Food and Drug Administration (FDA).
The use of the Genesis platform has significantly increased the number of blood samples that can be tested daily for HIV-1 and HCV viruses. The automated system includes barcoding functions and has a unique design that prevents cross-contamination by allowing safe pipetting of all blood samples.
Emile Sutcliffe, Chief Executive Officer of the Tecan Group, remarked: “Tecan has a strong track record in combining the latest developments in nucleic acid testing with its automation platforms.” He added: “The possibility for automated extraction and analysis of nucleic acids from more than one type of RNA virus in the same blood sample will bring major advantages to our partners in clinical diagnostics as it has for our customers in the blood screening market.”
In January 2002, Chiron’s worldwide share of the nucleic acid testing blood screening market was estimated at 26% for the Procleix™ HIV-1/HCV assay system (company figures1, 50 million blood donations annually in targeted markets). The worldwide business opportunity is estimated at above USD 500 million per annum.
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