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Dx Focus: BD Max Cdiff; Hologic Aptima HPV; Inostics BEAMing Tech; Veredus Labs VereFlu Test


Becton Dickinson said this week that it has received clearance from the US Food and Drug Administration to market the BD Max Cdiff assay. The assay is performed on the fully automated BD Max system and is designed to rapidly and accurately detect the toxin B gene in patients suspected of Clostridium difficile infection.

Rapid, accurate identification of infected patients enables timely and appropriate therapy and infection control interventions to prevent the spread of this infection in healthcare institutions. BD noted that molecular testing has been proven to reduce the number of healthcare facility-associated cases of C. difficile infections.

BD's Cdiff assay was CE-marked in March 2012. It is the third FDA-cleared assay on the BD Max system. Other available assays include BD Max MRSA to detect methicillin-resistant Staphylococcus aureus and BD Max GBS to detect Group B Streptococcus. Both assays were categorized by FDA as CLIA moderate complexity tests.

Hologic said this week that Health Canada has approved Hologic's Aptima HPV and Aptima HPV 16 18/45 genotype assays for use on the Tigris system.

Both assays are in vitro nucleic acid amplification tests to detect human papilomavirus strains associated with cervical cancer and precancerous lesions, Hologic said.

The US Food and Drug Administration approved the Aptima HPV Assay in 2011 and the Aptima HPV 16 18/45 Assay last fall. Both assays were developed by Gen-Probe, which Hologic acquired during the summer.

Aptima HPV detects 14 high-risk HPV types and was approved by Health Canada for two uses — the screening of patients with atypical squamous cells of undetermined significance cervical cytology results to determine whether patients should be referred to colposcopy; and for use adjunctively with cervical cytology to screen women at least 30 years old to evaluate the presence or absence of high-risk HPV types.

Aptima 16 18/45 is for use in women who have tested positive with the Aptima HPV Assay, and it was approved by Health Canada as an adjunct test with the Aptima HPV Assay in women at least 30 years old and in combination with cervical cytology to assess the presence or absence of HPV genotypes 16, 18, and/or 45.

It also received approval as an adjunct test to be used with the Aptima HPV Assay for women at least 21 years old with atypical squamous cells of undetermined significance or cervical cytology results for evaluating the presence or absence of HPV genotypes 16, 18 and/or 45.

Results from the Aptima 16 18/45 Assay are not intended to prevent women from proceeding to colposcopy, Hologic noted.

Inostics said this week that a DNA blood test using its BEAMing digital PCR technology can detect more mutations associated with secondary drug resistance in gastrointestinal stromal tumor patients than testing using conventional biopsies.

At the American Association for Cancer Research meeting this week in Washington, DC, researchers from the Ludwig Center at Dana-Farber Cancer Institute and Harvard Medical School presented data from a sub-analysis of the phase III GIST-Regorafenib in Progressive Disease, or GRID, trial, designed to assess the efficacy of regorafenib in patients with GIST.

Comparing conventional sequencing on tumor tissue with data generated using the BEAMing technology on blood samples, the researchers found resistance mutations four times more often in blood samples (48 percent) than in tumor tissue samples (12 percent), Inostics said. Furthermore, nearly half of the blood samples that had secondary KIT mutations harbored multiple secondary mutations, according to the study.

"To develop the right drug for the right patient, and to use those drugs most effectively, we need to understand the tumor burden in patients as fully as possible," George Demetri, director of the Ludwig Center and an author on the study, said in a statement.

"Inostics' BEAMing technology may offer physicians a real-time composite picture of all the mutations across all tumors in any given patient using just a simple blood sample," Demetri added. "By using this technology we hope to develop the most rational drug combinations and better tests to match patients with the most effective therapies going forward."

BEAMing technology is a combination of digital PCR and flow cytometry originally developed by the group of Bert Vogelstein at Johns Hopkins University. Inostics licensed the technology and adopted it for routine use.

The technology is a sensitive and quantitative method to detect tumor-specific somatic mutations in blood samples. Inostics offers BEAMing services to support clinical trials and research in oncology, as well as a CLIA-certified laboratory-developed test for routine clinical analysis (PCR Insider, 6/28/2012).

Understanding the need of even more comprehensive coverage to detect de novo resistance mutations, Inostics is currently developing a sequencing-based technology, the company said.

"We are combining our expertise for highly sensitive mutation detection using BEAMing with the power of sequencing to hopefully detect all potential primary and secondary resistance mutations in the KIT gene in the near future," Inostics CTO Philipp Angenendt said in a statement.

Veredus Laboratories said this week that it has shown in silico that the current version of its VereFlu test detects the current subtype of H7N9 (avian influenza) that is responsible for the recent flu outbreak in China.

Launched in 2008 and built on the STMicroelectronics lab-on-chip platform, VereFlu runs on Veredus' VerePlex biosystem, which integrates PCR and microarray technologies on a portable, automated chip-based platform.

VereFlu can rapidly detect all major influenza types at the point of need within two hours, providing genetic information on the infection that traditionally could take days to weeks to learn, the company said. In addition to the current H7N9 strain, VereFlu can identify and differentiate human subtypes of Influenza A (H1, H3, H5, H7, H9) and B viruses, including the avian flu subtype H5N1, and the 2009 pandemic H1N1/2009, all in a single test.

"After learning of the outbreak in China, we have confirmed in silico that our current VereFlu influenza panel is able to detect the subtype of H7N9 responsible for this outbreak in addition to other human flu A and B infections," CEO Rosemary Tan said in a statement.

Veredus is a Singapore-based majority-owned subsidiary of STMicroelectronics, a global semiconductor leader serving customers across the spectrum of electronics applications. The company was founded in 2003 and launched its first products in 2005.