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Dx Focus: Great Basin Gets FDA OK for C. Diff Test; Qiagen-Cardinal Health Pact; and More


Great Basin said this week that it has received 510(k) clearance from the US Food and Drug Administration for its first molecular diagnostic test, an assay for Clostridium difficile.

Great Basin filed its FDA submission for the C. difficile test in November (PCR Insider, 11/17/2012).

The test is contained in an integrated disposable cartridge containing all necessary reagents, and runs on Great Basin's yet-to-be-named automated testing platform that features a chip-based detection component based on thin-film biosensor technology, as well as dedicated analysis software. The testing platform also multiplexes up to 64 distinct targets in a single assay; provides sample-to-answer results in less than an hour, depending on the target; and features on-demand testing with no test batching.

The company's goal is to deliver assays that can be performed in a CLIA-waived or moderately complex laboratory at a lower cost than other molecular diagnostics.

Great Basin said that it intends to initiate clinical trials for a broad panel sepsis assay and a fungal pathogen assay this year (PCR Insider, 3/8/2012). The company said it also is launching its C. difficile test as a CE-IVD product in Europe and has begun marketing it in the European Union through local distributors.

Qiagen said this week that Cardinal Health will make Qiagen's molecular diagnostics products available to small and mid-sized hospitals in the US not covered by Qiagen's own sales channels.

Based in Dublin, Ohio, Cardinal Health distributes pharmaceuticals and medical products to healthcare providers and has annual sales of $103 billion.

The deal is anticipated to create critical mass for the distribution of molecular diagnostic products to the approximately 5,000 community hospitals in the US, "thereby supporting the adoption of in-house molecular diagnostic testing among smaller US hospitals," Qiagen said in a statement.

Qiagen said it will provide application and technical support to Cardinal Health customers. Financial and other terms of the deal were not disclosed.

In the US, Qiagen's molecular diagnostics product offerings include its Rotor-Gene Q MDx platform, which was recently cleared by the US Food and Drug Administration, along with the Artus Influenza A/B assay. The company intends to obtain FDA approval for the entire QIAsymphony RGQ system, including the Rotor-Gene Q series instruments and a pipeline of corresponding tests under development.

JS Genetics this week announced the availability of XCAT-KS, its buccal swab test for diagnosing Klinefelter syndrome and other male sex chromosome aneuploidies.

XCAT-KS is a PCR/pyrosequencing-based test that identifies Klinefelter syndrome and other male sex chromosome aneuploidies with 100 percent sensitivity and specificity as detailed in a validation study published last month in the International Journal of Pediatric Endocrinology.

The results of the XCAT-KS test will typically be available within three business days following receipt of the buccal swabs at JS Genetics' CLIA-certified laboratory in New Haven, Conn.

Klinefelter syndrome, a condition in which males have an extra X chromosome, is one of the most common genetic abnormalities in males. It is estimated that about one in every 500 males has an extra X chromosome.

SeraCare Life Sciences said last month that it has launched the HPV Genotyping Qualification Panel.

The new panel provides multiple vials of high-risk HPV genotypes for the replicate testing that is frequently performed during qualification testing, SeraCare said.

The panel is derived from cultured human cells containing full-length HPV DNA and includes the HPV 16 and HPV 18 genomes, which together account for an estimated 70 percent of all cases of the virus. The panel is designed to support all steps in assay qualification and testing, from extraction to detection; and is designed for use with HPV test kits from Roche, Qiagen, and Hologic, SeraCare said.