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Dx Focus: Cepheid Xpert CT/NG; Qiagen Therascreen EGFR; Luminex xTag GPP; Hologic Aptima Trichomonas

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Cepheid said this week that the US Food and Drug Administration has categorized its Xpert CT/NG test as moderate complexity under the clinical laboratory improvement amendments.

Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae. The test runs on Cepheid's GeneXpert molecular testing system, and is the first molecular CT/NG test to be categorized as moderately complex and the twelfth Cepheid test to be categorized as such, Cepheid said.

"Now accessible to more than 20,000 moderately complex US labs and 7,000 high-complexity US labs, Xpert CT/NG becomes an important new weapon in reducing STD rates as clinicians can test, consult with, and treat their patients on a more timely basis," Cepheid CEO John Bishop said in a statement.

"The classification of Xpert CT/NG by the FDA as 'moderate complexity' is a breakthrough for sexual health and STD prevention," Jeffrey Klausner, professor of medicine at the UCLA-David Geffen School of Medicine, said in a statement. "The large number of moderate complexity point-of-care laboratories that exist in US hospitals and clinics can now offer rapid, highly accurate, and private same-day STD testing."

Cepheid said it will begin shipping the test this month.


Qiagen said this week that it has submitted its Therascreen EGFR RGQ PCR kit to the US Food and Drug Administration as a proposed companion diagnostic for Boehringer Ingelheim's non-small cell lung cancer drug afatinib.

The test runs on the Qiagen Rotor-Gene Q real-time PCR system, which received 510(k) approval from the FDA in April 2012 along with the company's Artus Influenza A/B kit.

Qiagen said that it had submitted a premarket approval application for use of the EGFR test to determine which NSCLC patients would be potentially eligible for treatment with afatinib. The Therascreen EGFR test was developed in collaboration with Boehringer Ingelheim.

Afatinib was granted a priority review by the FDA as a proposed treatment of patients with locally advanced or metastatic NSCLC with an EGFR mutation detected by an FDA-approved test. The drug also was submitted for European approval in September 2012, and the Therascreen EGFR test has already received the CE Mark. In addition, the test has received marketing approval in Japan.

The Therascreen EGFR test will add to Qiagen's menu of Therascreen assays including the KRAS RGQ PCR kit, which the company launched last year in the US.


The US Food and Drug Administration has cleared Luminex's xTAG Gastrointestinal Pathogen Panel for marketing in the US, the company said this week.

The assay is cleared to run on the Luminex 100/200 system, and is "the first comprehensive molecular diagnostic assay that tests more than 90 percent of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay," Luminex said.

A nucleic acid amplification assay, xTAG GPP simultaneously tests for 11 common gastroenteritis-causing viruses, bacteria, and parasites, including Campylobacter; Clostridium difficile toxin A/B; Escherichia coli 0157; enterotoxigenic E. coli LT/ST; Shiga-like toxin-producing E. coli stx1/stx2; Salmonella; Shigella; rotavirus A; norovirus GI/GII; Giardia lamblia; and Cryptosporidium.

Assay results are presumptive and must be confirmed by FDA-cleared tests or other acceptable methods, Luminex said.


Hologic said this week that the US Food and Drug Administration has cleared for marketing its Aptima Trichomonas vaginalis assay to run on the Panther system.

The assay was previously cleared by the FDA in April 2011 for use on Gen-Probe's Tigris System (PCR Insider, 4/21/2011). Gen-Probe was acquired by Hologic for $3.7 billion last year.

The Panther system, a fully automated and integrated molecular testing platform aimed at low- and medium-volume labs, was cleared for marketing by the FDA in May 2012. According to Hologic, the Trichomonas vaginalis assay remains the only FDA-cleared amplified nucleic acid test on the market for detecting the microorganism.

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