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Maine Molecular Quality Controls Expands
Cystic Fibrosis Test Panel Control to 79 Mutations

Maker of only FDA-cleared quality control for molecular CF test extends capacity, capability of labs with largest set of genetic mutations available

Scarborough, Maine – Further extending the ability of medical laboratories around the world to support in vitro diagnostic testing for cystic fibrosis, Maine Molecular Quality Controls Inc. (MMQCI) announces it has expanded the range of its synthetic multiplex control to a set of 79 mutations known to be associated with the deadly disease.  INTROL™ CF Panel III is the third multiplex genetic control produced by the pioneering, Maine-based MMQCI, developer of the only FDA-cleared multiplex genetic control for cystic fibrosis testing.

INTROL’s synthetic makeup means diagnostic labs now have a reliable source of high-quality controls that do not require the time, cost, and limited resources of traditional biological controls. As a result, testing for an increasing number of cystic fibrosis mutations can be achieved with greater efficiency and confidence, including the 23 mutations recommended by the American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG), as well as mutations known to occur within specific ethnic groups.

As a result, testing for an increasing number of cystic fibrosis mutations can be achieved with greater efficiency and confidence, including the 23 mutations recommended by the American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG), as well as mutations known to occur within specific ethnic groups.

“Quality controls are an important part of the diagnostic process, and are required by law on DNA-based test platforms,” said Joan H. Gordon, MT (ASCP), CEO and co-founder of Maine Molecular Quality Controls. “Providing the industry with a source of multiplex controls not only increases the number of tests a lab is able to conduct, but by enabling reliable in vitro testing for cystic fibrosis, we’re helping doctors detect and begin treatment for this horrible disease much earlier.”

In 2006 MMQCI’s groundbreaking INTROL™ CF Panel I control, including 38 CF mutations, was the first synthetic genetic quality control to earn approval from the FDA, and remains the only such product with that distinction. INTROL™ CF Panel II, with support for 53 known CF mutations, followed. Significantly, the range of 79 mutations currently supported by INTROL means individuals can now be tested for more mutations to determine if they are carriers of the disease.

As knowledge and need increases, MMQCI says it will continue to advance the capabilities of the INTROL CF Panel family of controls. Meanwhile, the company is working to develop new synthetic genetic controls for use in pharmacogenetics.

“We intend to advance our capabilities into new areas of molecular testing to address not only disease diagnostics, but also therapeutic efficacy,” Gordon said.

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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 www.mmqci.com.




 


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