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Dx Focus Aug 5, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Life Technologies this week launched the MicroSEQ E. coli O157:H7 assay, and said that the test has secured Performance Tested Methods certification from the AOAC Research Institute for detecting bacteria in the food supply.

Based on Life Tech's real-time PCR technology, the MicroSEQ E. coli test is highly specific and sensitive and can be run in as little as eight hours, the company said.

The assay joins Life Tech's portfolio of MicroSEQ kits designed to detect pathogens that contaminate the food supply, including kits for Salmonella, Listeria monocytogenes, and Listeria spp.

BD Diagnostics, a segment of Becton Dickinson, said this week that its BD MAX GBS assay for Group B Streptococcus on the BD MAX system has received "moderate complexity" designation from the US Food and Drug Administration under the Clinical Laboratory Improvement Amendments act.

BD said that the new designation will increase access to cost-effective molecular testing for a wide range of laboratories performing GBS screening.

The BD MAX GBS assay is the only fully automated PCR method using Lim broth, which provide a high level of sensitivity and rapid results for detecting GBS, BD said. The test is also the first offering in a "broad menu of infectious disease tests under development" for BD MAX, the company said.

The Scan

Less Than Half

An effort to reproduce key findings from high-profile preclinical cancer studies finds less than half could be replicated, according to the Scientist.

Still Some SARS-CoV-2 Sequencing Holes

The Wall Street Journal reports that viral genomic surveillance has improved in the US, though says there are still gaps.

Avoiding Passing Them On

People with known disease-linked genetic variants are turning to in vitro fertilization so as to not pass those variants to their children, the Washington Post says.

PNAS Papers on Long Cell-Free DNA in Maternal Plasma, Genetic Propensity for Voting

In PNAS this week: long, cell-free DNA of maternal and fetal origins identified in maternal plasma, and more.