Maine Molecular Quality Controls Offers First Commercially Available Genetic Test Controls for Hereditary Hemochromatosis

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As FDA, CDC Announce Stricter Quality Guidelines, Quality Control Innovator Expands Product Line

Maine Molecular Quality Controls announced the release of the INTROL™ HH line of controls.

As medical labs adopt a broader array of genetic test platforms, the availability of quality controls is of vital importance in order to support accurate disease detection and diagnosis.

Even as the federal government said it will impose stricter quality standards for genetic testing, Maine Molecular Quality Controls Inc.(MMQCI) announced the availability of a new line of controls in support of diagnostic tests for mutations associated with hereditary hemochromatosis. INTROL™ HH Panel I, INTROL™ HH Panel II, and INTROL™ HH Wild Type controls are part of the growing INTROL™ line of genetic controls produced by MMQCI, developer of the only FDA-cleared genetic control for cystic fibrosis testing.

The INTROL™ HH line of controls are the first commercially available quality controls for hereditary hemochromatosis, an autosomal recessive iron absorption disorder characterized by excess iron deposited in joints, heart, liver, and other organs. Untreated, hereditary hemochromatosis can lead to organ damage, and in extreme cases, death. Availability of the INTROL™ HH line of quality controls means that molecular tests for the genetic mutations associated with the disease can be achieved with greater accuracy and efficiency. Genetic testing can diagnose hereditary hemochromatosis before symptoms appear, and is more accurate than traditional biochemical testing, which can produce false negative and false positive outcomes.

“As medical labs adopt a broader array of genetic test platforms, the availability of quality controls is of vital importance in order to support accurate disease detection and diagnosis,” said Joan H. Gordon, MT (ASCP), CEO and co-founder of Maine Molecular Quality Controls. “What’s more, our mission to provide a reliable source of quality controls has been further validated by recent announcements from the federal government, including the new guidelines covering molecular genetic testing due in 2011.”

During June the Centers for Disease Control and the Food and Drug Administration both announced initiatives to raise standards for and increase oversight of the use of laboratory developed tests, specifically related to molecular genetic tests. Since there are no manufactured FDA-cleared tests for hereditary hemochromatosis, all tests for the disease are laboratory developed, putting the burden of providing controls on the laboratory. INTROL™ HH is a new source of controls that can provide confidence in test results of laboratory developed tests for hereditary hemochromatosis.

In addition to hereditary hemochromatosis, MMQCI develops and markets quality controls supporting molecular diagnostic tests for other genetic diseases and disorders, including the only FDA-cleared genetic control for cystic fibrosis testing.

Founded in 2000, Maine Molecular Quality Controls Inc. (MMQCI) designs and markets molecular controls for use in inherited disease testing, infectious disease detection, and pharmacogenetics. The company produces high caliber controls to monitor all phases of molecular testing as required by best practice and regulations, providing greater confidence in test results. MMQCI is located in Scarborough, Maine. For more information visit http://www.mmqci.com.

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