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Dx Focus Aug 4, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


Intelligent Medical Devices said this week that it has received the CE Mark for a high-throughput automated assay for detecting Clostridium difficile, including the A-B+ 1470 variant and the NAP1 strain.

The IMDx C. difficile assay for the Abbott m2000 is the first assay released under a multi-year distribution agreement signed in January between Abbott and IMDx. Under the terms of the agreement, IMDx, based in Cambridge, Mass., is designing, developing, seeking regulatory clearance for, and manufacturing assays for Abbott's m2000 instrument.

IMDx said that its C. difficile assay demonstrated a sensitivity of 95.7 percent and a specificity of 100 percent in internal studies.

"Not only do we offer automated detection of toxigenic C. difficile genes, shortening the time needed to diagnose infections, but we also cover the detection of hypervirulent strains, including NAP1, and tcdB-variant strains, including 1470," IMDx Chairman and CEO Alice Jacobs said in a statement. "Early identification of pathogens is critical in improving patient healthcare, shortening hospital stays, and reducing expenses."

Other tests being developed by IMDx under the Abbott agreement include assays for vancomycin-resistant Enterococci, Group B Streptococci, influenza A/B, and herpes simplex virus 1 and 2. In addition, the agreement covers tests for determining viral load for Epstein-Barr virus and BK virus outside the US.

Medical Diagnostic Laboratories has introduced a qPCR panel for bacterial vaginosis testing and lactobacillus profiling, the company said last week.

This new panel is a "significant advancement beyond the qualitative identification of BV-associated microorganisms since it now covers microbial markers of the normal vaginal environment," the company said. As such, the assay will allow physicians to monitor the efficacy of antimicrobial therapy by evaluating changes in bacterial composition during the course of treatment and post-treatment, as well as recurrence of BV due to re-infection with BV-associated microorganisms.

Located in Hamilton, NJ, MDL is a CLIA-certified infectious disease laboratory specializing in high-complexity automated DNA-based molecular analyses.

Seegene last week introduced its Anyplex plus MTB/NTM/DR-TB real-time test for diagnosing Mycobacterium tuberculosis.

Anyplex plus MTB/NTM/DR-TB detects M. tuberculosis, non-tuberculosis mycobacteria, and the presence of key resistance mutations to anti-MTB drugs in a single test.

The test first detects MTB and discriminates it from NTM in less than two hours. In the case of MTB-positive results, further analysis for resistance to isoniazid, rifampicin, all fluoroquinolone, and injectable drugs (i.e. amikacin, kanamycin, or capreomycin) is performed to identify whether the MTB is multi drug-resistant or extensively drug-resistant in less than 40 minutes.

In the case of NTM-positive results, subsequent testing to identify the three species most associated with human disease — M. avium complex, M. kansasii, and M. abscessus — is carried out. This testing process is expected to provide a "one-stop diagnostic workflow for prompt mycobacteria detection and treatment," Seegene said.

Anyplex plus MTB/NTM/DR-TB is not available in the US, the company said.