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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Mar 18, 2010


Promega said this week that its Maxwell 16 IVD System instrument is CE marked for in vitro diagnostic use in European clinical labs, along with the Maxwell 16 Blood DNA Purification System and the Maxwell 16 Viral Total Nucleic Acid Purification System.

The benchtop Maxwell 16 IVD System can purify 16 samples simultaneously and includes integrated bar code reading and a UV lamp for sanitization.

Clinical labs can extract DNA from whole or fractionated blood using the Maxwell 16 Blood DNA Purification System, or viral nucleic acid from plasma or serum samples using the Maxwell 16 Viral Total Nucleic Acid Purification System. The extracted nucleic acids can then be used in "standard amplification-based diagnostic assays," Promega said.

Norgen Biotek has launched more than 30 new kits for nucleic-acid based diagnostics.

The new products include kits for the diagnosis of human pathogens such as HPV, HIV, HCV-1 & 2, HBV, chlamydia, and gonorrhea; kits for the detection of food-borne pathogens, including Listeria, Salmonella, and Streptococcus species; and kits for the detection of plant pathogens, such as plum pox virus, Aspergillus, Penicillium, and Boytritis.

Norgen said that the diagnostic kits include all components for isolating nucleic acids, as well as the required master mixes and controls for PCR amplification and detection. The kits also include controls to eliminate false negatives and problematic isolations, the company said.

Norgen said that the kits are currently for research use only, but said in a statement that it plans to "transition" its technology into diagnostic use.

The Scan

Just Breathing

A new analysis suggests that most Mycobacterium tuberculosis is spread by aerosols from breathing, rather than by coughing, the New York Times reports.

Just Like This One

NPR reports that the World Health Organization has hired a South African biotech company to recreate mRNA vaccine for SARS-CoV-2 that is similar to the one developed by Moderna.

Slow Start

The Wall Street Journal reports that Biogen's Alzheimer's disease treatment had revenues for July through September that totaled $300,000.

Genome Research Papers on Cancer Chromatin, Splicing in the Thymus, Circular RNAs in Cancer

In Genome Research this week: analysis of bivalent chromatin sites, RBFOX splicing factors' role in thymic epithelial cells, and more.