A Diagnostics & Imaging Week

Abbott Laboratories (Abbott Park, Illinois) and Celera Diagnostics (Alameda, California), a joint venture between Applied Biosystems (Foster City, California) and the Celera Genomics Group (also Foster City) of Applera (Norwalk, Connecticut), reported that Abbott has received CE marking for a real-time polymerase chain reaction (PCR) test for monitoring HIV-1 viral load in patients.

The Abbott RealTime HIV-1 assay was developed for use on the Abbott m2000 system, an automated instrument using real-time PCR technology for the detection and quantification of infectious agents. Abbott said that additional tests are in development for its m2000 system, including methods for detecting hepatitis C, hepatitis B, chlamydia and gonorrhea.

Anna Maria Geretti, MD, PhD, head of the retrovirology laboratory at Royal Free Hospital (London), said, "With the dramatic improvements in antiretroviral therapy for patients infected with HIV, the ability to accurately and quickly measure virus levels in the blood is essential in providing optimal treatment for patients and improving the quality of their lives."

Geretti's laboratory was one of more than 20 clinical sites in Europe to participate in the evaluation of the RealTime HIV-1 assay and the m2000 system. "Our experience with this test has demonstrated its effectiveness in quantifying the diverse subtypes of this virus across a wide range of plasma RNA levels," she said.

Real-time PCR, a modification of standard PCR, is a system for "amplifying" DNA which can be detected in real time, rather than at the end of the process, hence ensuring more accurate and precise quantification. The reaction proceeds without the need for user intervention, providing increased productivity, reduced opportunity for human error, and more consistent, reproducible results.

The m2000 instrument system purifies the nucleic acid from the specimen and automatically combines this with the assay reagents. The system's software, described as user-friendly, provides results automatically calculated to provide highly reliable results for HIV viral load testing.

Abbott calls the assay "among the most sensitive viral load tests available today, with a broad dynamic range, capable of detecting HIV-1 in plasma down to as few as 40 RNA molecules per milliliter and as high as 10 million RNA molecules per milliliter, thereby reducing the need for sample dilutions and additional testing."

Thomas White, PhD, chief scientific officer for Celera, said, "We're particularly pleased with the robustness of this real-time test system and the accuracy and precision of the assay on the many subtypes of the virus." He noted that previously rare forms of AIDS are becoming more frequent in developed countries. "By detecting these viral subtypes and also predicting whether they will be sensitive to various antiviral drugs, we are developing molecular diagnostics that help physicians determine the best possible course of treatment."

In 2002, Abbott and Celera entered into a long-term alliance to develop and market a range of in vitro molecular diagnostics for disease detection and monitoring and therapy selection. Celera's focus is on assay development and genetic marker discovery and validation. Abbott's focus product development and marketing and it is the worldwide distributor for most products developed by the alliance.

Immucor in Japanese distribution j-v

Immucor (Norcross, Georgia), a provider of automated instrument-reagent systems to the blood transfusion industry, reported that it has agreed with Kainos Laboratories to restructure Kainos' distribution of Immucor products in Japan. Immucor and Kainos will own 51% and 49%, respectively, of a newly formed joint-venture company that will become Immucor's distributor in Japan.

The formation of the joint venture is subject to the approval of Kainos shareholders, expected to come at a meeting scheduled for today. Assuming approval, the j-v would be established on or about July 1.

Immucor has agreed to pay Kainos about $3.7 million for its initial 51% interest in the j-v and expects to buy the remaining 49% interest at a later date for about the same price. Immuncor said that Kainos has agreed to provide "certain services" to the j-v company.

Dr. Gioacchino De Chirico, president of Immucor, said, "We are pleased to take this key step toward direct distribution in Japan, the third-largest transfusion diagnostics market in the world after Europe and the U.S. We believe this joint venture will enable Immucor to accelerate its penetration of this important and attractive market."

Hiroshi Hoketsu, who recently joined Immucor's board following more than 20 years as president of Ortho Clinical Diagnostics in Japan, said, "The transfusion diagnostics market in Japan will benefit from Immucor's expanded direct presence through this joint venture."

Immucor manufactures reagents and systems used by hospitals, reference laboratories and donor centers to detect and identify certain properties of the cell and serum components of blood prior to transfusion. It also markets a family of automated instrumentation for various market segments.

Kainos develops diagnostic reagents, pharmaceuticals and medical instruments.

NorDiag adds licenses from Genzyme

NorDiag AS (Bergen, Norway) reported signing a license agreement with Genzyme (Cambridge, Massachusetts) for European rights to the p53 and APC genes. NorDiag said the agreement would allow it to incorporate additional gene markers into its Genefec assay for the early detection of colorectal cancer and "further increase the sensitivity of the assay and allow it to detect colorectal cancer at an even earlier stage."

The Genefec assay is described by NorDiag as a non-invasive test that uses fecal samples as the specimen. The test is specific, easy to automate and ideal for use in both a diagnostic or screening environment.

Christian Horn, chairman of NorDiag, said, "Our Genefec assay already allows for pre-malignant colorectal cancer to be detected at a stage when the chances of successful treatment are high. However, the addition of these extra markers will further increase our assay's sensitivity, making it an even better tool for both diagnostic and public screening programs."

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