This Week In Diagnostics

Life Technologies to distribute Quidel’s tests in Europe

Life Technologies Corp. (NASDAQ: LIFE) reports that it has signed an agreement with Quidel to distribute and commercialize molecular diagnostic assays for the European market. Although financial terms were not disclosed, the company will sell Quidel’s current and future assays in Europe, where Life has an established distribution network. Beginning in October, Life Technologies will distribute the Quidel® Molecular Influenza A+B Real-Time RT-PCR Assay and hMPV (human metapneumovirus) kits to European markets. Both kits are for use with Life’s 7500 family PCR Instruments, which are installed in hundreds of clinical diagnostic labs across Europe.


Positive results for AIM’s program for improving echocardiography

AIM, a specialty benefit management company reported the results of a customer case study that shows prospective clinical review for echocardiography improves the clinical appropriateness of cardiac imaging services and helps prevent unnecessary utilization. Using a rigorous methodology, AIM evaluated a client population of approximately three million members over a two-year period in 2009 and 2010 to determine the impact its echocardiography clinical review program had on provider ordering behaviors and utilization patterns. The study found that the clinical review program resulted in a decrease in utilization of certain cardiac imaging services of 18 percent, compared to the same period the year before the program was implemented. The program demonstrated success especially in managing utilization on the front end of the ordering process through efficient evaluation of orders along with focused provider education, where necessary, as opposed to a high rate of denials.


CE Mark for IMDx test

IntelligentMDx (IMDx) has received the CE-Mark for its second automated molecular test for the Abbott FDA cleared m2000 instrument. The IMDx™ VanR for Abbott m2000™ test detects and distinguishes the vanA and vanB genes most commonly found in vancomycin-resistant enterococci in specimens from patients at risk for colonization or infection. Detection of both the vanA and vanB genes allows for identification of a higher number of at-risk patients than existing tests that only target the vanA gene.


Orion Genomics licenses technology to Qiagen

QIAGEN has non-exclusively licensed Orion Genomics’ MethylScreen™ technology for research use in EpiTect™ Methyl qPCR Array System reagent kits. These kits are used in the epigenetics field to analyze the DNA methylation status of genes with quantitative PCR. Orion Genomics has developed two technologies that enable the discovery of methylation-based biomarkers and the development and commercialization of corresponding assays. MethylScope® technology, covered by two issued US patents, uses microarrays or next generation sequencing to build high-resolution, genome-wide methylation maps that enable the discovery of disease-associated biomarkers.


Cervical disease detection

OncoHealth Corporation, a protein biomarker diagnostics company, provided new study data showing that the company’s proprietary HPV E6 and E7 oncoprotein assays correlated with cervical disease grade and may distinguish cervical disease or cervical cancer from clinically insignificant HPV infection. These new data were shared in presentations at the 27th International Papillomavirus Conference, held in Berlin, Germany. The oral and poster presentations suggest that the company’s technology platform may be appropriate for high-throughput ELISA and flow cytometry testing of cervical cytology samples. When used in cervical cancer screening and diagnosis, the company’s assays may provide information that would enable physicians to better determine which women can avoid additional testing and/or procedures.


OvaGene laba gets CLIA certification

OvaGene Oncology has received Clinical Laboratory Improvement Act (CLIA) certification for their newly constructed state-of-the-art molecular diagnostics laboratory.  The OvaGene laboratory is now fully-licensed to receive patient clinical specimens from gynecologic oncologists across most of the U.S.

OvaGene plans to launch a series of gene-based profile assays over the next couple of months for ovarian, endometrial and cervical cancers.  The initial tests include a proprietary protein expression assay for the prediction of recurrence in early stage endometrial cancers and two gene-based profile panels: gynecologic cancer targeted therapy assessment and endometrial cancer recurrence/drug response assessment.  OvaGene plans to make these assays, and other complementary tests, commercially available in October.


European “green light” for imaging software

VIDA Diagnostics, a developer of quantitative pulmonary imaging software, has achieved International Organization for Standardization (ISO 13485) certification and CE certification for its flagship product, Apollo®. This permits VIDA to sell Apollo for clinical use in the European Economic Area (EEA) and Switzerland. Apollo currently has FDA 510(k) approval for clinical use in the U.S.


VentriPoint launches clinical trial

VentriPoint Diagnostics (TSX VENTURE:VPT) (PINK SHEETS:VPTDF) has begun  a clinical trial to validate its VMS™ 3D imaging technology in patients with the most common form of congenital heart disease, Tetralogy of Fallot or Blue-baby Syndrome. This trial is being led by Dr. John Kovalchin, Director of Echocardiography at The Heart Center at Nationwide Children’s Hospital in Columbus Ohio. Dr. Kovalchin has already enrolled eight patients into the trial, which is planned to enroll a total of 83 patients at five centers in the United States.


True Diagnostics receives sFDA clearance

True Diagnostics has received sFDA clearance for its TrueDX™ Platform with its first test for TSH and expects shipments to China to begin before the end of the year. The platform produces quantitative results using LFIA (Lateral Flow Immunoassay) technology and measures the severity of conditions, produces results in minutes from a finger prick of blood (or small urine or saliva sample), and is portable.


Multiplex PCR test detects STDs

Seegene has commercialized their first real-time assay based upon its new TOCE technology. The Anyplex™II STI-7 Detection Assay will provide clinicians with a new tool to help protect health and prevent the spread of sexually transmitted infections. The assay, the company reports, is the only multiplex real- time PCR test that can simultaneously detect seven of the more common causes of STIs from a wide range of specimen types such as, urine, vaginal and urethral swabs, and liquid-based cytology specimen. They include: Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, Trichomonas vaginalis, Ureaplasma urealyticum, and Ureaplasma parvum.

–Peter Winter

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