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Dx Focus Jun 17, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


The US Food and Drug Administration has approved Roche Molecular Diagnostics' new dual-PCR target HIV-1 viral load test to quantify the amount of virus in a patient's blood.

The Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 is the first quantitative viral load test to amplify and detect two separate regions of a target genome, Roche said.

The fully automated test is able to detect HIV-1 RNA (group M and O) down to 20 copies per mL in EDTA plasma, according to Roche. It is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1-infected patients.

"By virtue of its design, the [test] can improve the ability of physicians and laboratories to obtain reliable information about HIV-infected patients in order to make informed treatment decisions," Roche Molecular Diagnostics CEO Paul Brown said in a statement.

The Cobas AmpliPrep/Cobas TaqMan system is used by more than 250 laboratories in the US for clinical viral load testing, Roche said. The HIV-1 viral load test may be run in parallel with hepatitis C viral load testing on the same system.

Cepheid last week received FDA clearance to market Xpert SA Nasal Complete, the first molecular test designed to simultaneously detect and differentiate Staphylococcus aureus and methicillin-resistant S. aureus colonization in less than an hour.

The test runs on Cepheid's GeneXpert system, and is the tenth test from the company to receive FDA clearance; and the sixth in Cepheid's hospital-acquired infection test portfolio. The GeneXpert system is a fully automated platform that combines sample preparation with real-time PCR amplification and detection.

"A rapid test for both SA and MRSA will have many applications for patients at risk of colonization," Samir Awad, associate professor of surgery and chief of critical care at Baylor College of Medicine, said in a statement.

"These applications include assisting physicians in targeting appropriate prophylactic therapy and decolonization to reduce the risk of post-surgical site infections," Awad added.

XPert SA Nasal Complete will be available for shipment this month, Cepheid said.

Viracor-IBT Laboratories last week announced the launch of its Aspergillus PCR panel, a collection of three tests to assist in detecting and measuring infiltrative pulmonary aspergillosis.

IPA is caused by Aspergillus, a common fungus with more than 100 species. The disease primarily affects immunocompromised patients, and typically progresses to pneumonia, but can also cause complications in the central nervous system, kidneys, heart, and liver.

The new panel includes three PCR assays: Pan-Aspergillus, which detects the presence of all Aspergillus species; and A. fumigatus and A. terrus, which detect the species that cause the majority of IPA infections.

The new testing service provides 24-hour turnaround, Viracor-IBT said. The test also expands Viracor-IBT's suite of fungal testing services, which include Platelia Aspergillus Galactomannan EIA and Fungitell beta-D Glucan.

German firms SIRS-Lab and Analytik Jena this week announced a collaboration focused on sepsis diagnostics.

Under the deal, AJ Innuscreen, a subsidiary of Analytik Jena, will provide SIRS-Lab with a platform and associated reagents for the automated isolation of nucleic acids. The Analytik Jena products are tailored to fully automate extraction of DNA in whole blood samples.

Barbara Staehelin, CEO of SIRS-Lab, said in a statement that a clinical study is underway to validate a PCR-based sepsis test currently under development. SIRS-Lab also said that it plans to pursue a CE-IVD mark for the test.

Financial terms of the deal were not disclosed.

SIRS-Lab, based in Jena, is a molecular diagnostics firm focused on sepsis and other life-threatening infections. Analytik-Jena provides analytical measurement systems.

The Scan

Tens of Millions Saved

The Associated Press writes that vaccines against COVID-19 saved an estimated 20 million lives in their first year.

Supersized Bacterium

NPR reports that researchers have found and characterized a bacterium that is visible to the naked eye.

Also Subvariants

Moderna says its bivalent SARS-CoV-2 vaccine leads to a strong immune response against Omicron subvariants, the Wall Street Journal reports.

Science Papers Present Gene-Edited Mouse Models of Liver Cancer, Hürthle Cell Carcinoma Analysis

In Science this week: a collection of mouse models of primary liver cancer, and more.