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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.

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