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Dx Focus Jan 7, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News

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Cepheid this week announced that the US Food and Drug Administration has granted Emergency Use Authorization for its Xpert Flu A Panel test and 510(k) clearance for Xpert vanA, a test for the antimicrobial resistance gene most commonly associated with vancomycin-resistant Enterococci. Both tests run on the company's GeneXpert real-time PCR platform.

Cepheid said that Flu A Panel identifies the 2009 H1N1 influenza virus in less than an hour.

The FDA has authorized the test to be used in laboratories certified under the Clinical Laboratory Improvement Amendments to perform moderate complexity testing, which allows the test to be performed "in hospital near-patient settings," Cepheid said.

"Although PCR testing is now recognized as the new gold standard for detection of influenza virus infection, test availability for 2009 H1N1 has so far been limited to high-complexity laboratories and results are not typically available around the clock," Cepheid CEO John Bishop said in a statement.

Cepheid said that it will continue to develop an expanded influenza panel that will test for influenza A subtypes H1, H3, and 2009 H1N1, and influenza B. The company intends to submit a separate 510(k) application for that product later this year.

The Xpert vanA test, meantime, is "the first rapid and accurate test released in the United States for vanA," Cepheid said.

Xpert vanA is the company's ninth test to receive FDA clearance, and the fifth in its portfolio of products directed towards hospital-acquired infections.

Cepheid said that the FDA-cleared Xpert vanA test will begin shipping this month.


Abbott said this week that it has received CE Marking in the European Union for its Abbott RealTime mS9 Colorectal Cancer test, a DNA-based assay that detects the methylated form of Septin 9, a gene linked to colorectal cancer, in blood specimens.

The test, intended to help physicians decide whether to refer a patient for colonoscopy, is the first automated assay for detecting the Septin 9 gene in plasma and the first cancer assay available with Abbott’s m2000 PCR-based molecular diagnostic system, the company said.

The product is not available for sale in the US.


Response Genetics said this week that it has tapped Genetic Technologies as the exclusive distributor in Australia, Indonesia, Malaysia, the Philippines, Singapore, and Thailand for its ResponseDX: Colon, ResponseDX: Lung, and ResponseDX: Gastric genetic test panels.

The PCR-based tests analyze the expression of genes that correlate with response to commonly used chemotherapy agents.

Response Genetics said that it has sold more than 4,700 ResponseDx tests since September 2008. In the US, the company sells approximately 1,800 tests per quarter with a reimbursement of around $1,400 per test.

ResponseDX tests are available in the US through direct sales and through NeoGenomics Laboratories, a national clinical reference laboratory that is authorized to offer the tests.

All tests are performed through Response Genetics' CLIA-certified laboratory.


The Scan

For Better Odds

Bloomberg reports that a child has been born following polygenic risk score screening as an embryo.

Booster Decision Expected

The New York Times reports the US Food and Drug Administration is expected to authorize a booster dose of the Pfizer-BioNTech SARS-CoV-2 vaccine this week for individuals over 65 or at high risk.

Snipping HIV Out

The Philadelphia Inquirer reports Temple University researchers are to test a gene-editing approach for treating HIV.

PLOS Papers on Cancer Risk Scores, Typhoid Fever in Colombia, Streptococcus Protection

In PLOS this week: application of cancer polygenic risk scores across ancestries, genetic diversity of typhoid fever-causing Salmonella, and more.