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Dx Focus Sep 22, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


Seegene this week introduced the Anyplex II STI-7 detection assay, a multiplex real-time PCR assay for several sexually transmitted infectious agents.

The Anyplex II STI-7 assay is the first test from Seegene to incorporate the company's recently introduced TOCE technology. Unveiled in July, TOCE, an undisclosed acronym, enables highly multiplexed melt curve analysis on existing commercial real-time PCR instruments (PCR Insider, 7/21/11).

It is the only multiplex real-time PCR test that can simultaneously detect seven of the more common causes of sexually transmitted diseases from a wide range of specimens including urine, vaginal and urethral swabs, and liquid-based cytology specimens, Seegene said.

The assay tests for Chlamydia trachomatis, Neisseria gonorrhea, Mycoplasma genitalium, Mycoplasma hominis, Trichomonas vaginalis, Ureaplasma urealyticum, and Ureaplasma parvum.

The Anyplex II STI-7 assay is not currently available in the US until it receives regulatory approval, Seegene said.

IntelligentMDx this week said that it has received the CE Mark for the IMDx VanR assay for detecting and distinguishing between the vanA and vanB genes most commonly found in vancomycin-resistant enterococci in specimens from patients at risk for colonization or infection.

IMDx VanR runs on the Abbott m2000 platform, and allows laboratories to obtain results for up to 48 patient samples in less than three hours, and up to 94 patient samples in less than four hours. The test exhibits high sensitivity and specificity when compared to traditional chromogenic agar methods, with values of 96.4 percent and 98 percent, respectively, the company said.

The assay is the company's second automated molecular test for the Abbott m2000 instrument. The company received the CE mark for the IMDx C. difficile test on the Abbott m2000 platform last month (PCR Insider, 8/4/11).

IMDx and Abbott signed a multi-year development and distribution agreement in January to design and manufacture assays on the m2000.

Amoy Diagnostics this week announced the commercial availability of a new lung cancer mutation panel that tests for mutations in EGFR (29 mutations), EML4-ALK (nine rearrangements), KRAS (seven mutations), and BRAF (V600E).

Amoy said that the EGFR, KRAS, and BRAF tests are marked for IVD use in Europe and approved for clinical use in China. Meantime, Chinese State Food and Drug Administration and CE Marking are pending for the EML4-ALK assay.

All four tests in the panel are based on a proprietary real-time PCR technology called AdX-ARMS, which uses a two-step amplification method to achieve a high degree of sensitivity and accuracy, according to the company.

The new panel "allows the definitive identification of mutations in four key oncogenes associated with response or resistance to targeted therapy," David Whyte, vice president of global development at Amoy Diagnostics, said in a statement, also noting that mutations in these four genes are found in about half of all non-small cell lung cancer samples.

The Scan

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.