New Instrumentation Offers Advantages in Diagnosis and Post-treatment Monitoring of Helicobacter pylori Infection


LAFAYETTE, Colo. -- Meretek Diagnostics Inc. announces that Otsuka Pharmaceutical Co., Ltd. (Japan) received Food and Drug Administration (FDA) clearance of its

510(k) application to market the POCone Infrared Spectrophotometer.  The POCone is a new instrument which offers several technological

advancements to aid in the detection of active H. pylori infection, and to

confirm eradication of infection through the patented 13C urea breath test

technology and methodology.


The POCone is an in-vitro diagnostic device designed to measure the change

of 13CO2 concentration in breath by infrared spectroscopic analysis and is

intended for use in conjunction with the BreathTek urea breath test, which

is commercially available through Meretek.  Urea breath testing is considered

the non-invasive gold standard for H. pylori infection, the leading cause of

peptic ulcer disease.  As the newest advancement in the Meretek family of

breath test technologies, the POCone offers physicians and practice staff the

following advantages when testing for active H. pylori infection:


    --  Software upgrade - Test administrators are now able to input letters

        and numbers to further complement patient identification information

        at the time of a breath sample collection.  Additionally, an internal

        timer alerts administrators to the optimal sample collection time

        during the 15-minute testing period.

    --  Improved result time - Results from analyzed breath test samples are

        available in approximately 2 minutes.

    --  Improved warm-up time - The POCone warms up in approximately 10

        minutes, reduced from 45 minutes.

    --  Reduced size - The smaller, table-top design requires limited office

        or laboratory space (8.6"W x 10"H x 12.75"D).

    --  Light weight - The unit weight makes it practically mobile (23 pounds).


"Meretek is committed to the continued research and development of

technological platforms for effective, proactive H. pylori management," said

Sara Davis, director of the marketing department for Meretek Diagnostics Inc.

"Today's announcement demonstrates our vision to improve health care in the

United States by providing the medical community with advanced instrumentation

for detecting active H. pylori infection and confirming eradication."


The POCone Infrared Spectrophotometer is available for use in the

qualitative detection of urease associated with H. pylori in the human stomach

and as an aid in the initial diagnosis and post-treatment monitoring of

infection in adults. 


Source: Meretek Diagnostics Inc.

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