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FDA Approves Roche HIV Viral Load Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Roche's HIV viral load test, the Swiss drug and diagnostics firm announced today.

The test, called Cobas TaqMan HIV-1 Test, v2.0, will be available later this year and targets two highly conserved regions of the HIV-1 genome, avoiding any regions that are targeted by current drugs. As a result, the test provides increased reliability "even with rare mismatches in primer/probe binding sites and when mutations are present," Roche said.

The test uses the FDA-approved High Pure System Viral Nucleic Acid Kit for manual preparation and the Cobas TaqMan 48 Analyzer for automated amplification and detection. Since Roche its dual-target approach for monitoring HIV-1 patients on antiretroviral therapy in 2008, more than 8 million tests have been performed on Roche fully automated real-time PCR platforms, it said.

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.