Document › Details
Metabolon, Inc.. (9/28/16). "Press Release: Metabolon Launches Meta IMD Test to Speed Diagnosis of Inherited Metabolic Disorders". Research Triangle Park, NC.
|Region||United States (USA)|
|Product||Meta IMD™ Test (CLIA LDT test)|
|Product 2||diagnostic services|
|Person||Ryals, John (Metabolon 200510 CEO)|
|Person 2||Fastenau, Robin (Metabolon 201409 VP Corporate Marketing + Communications)|
Test requires only a small plasma sample and delivers quick results to physicians
Metabolon, Inc., the global leader in metabolomics, announced today that Meta IMD™ is now available to physicians as a CLIA laboratory-developed test (LDT). The test identifies hundreds of metabolites associated with a wide range of inherited metabolic disorders (IMDs) from one small plasma sample, and results are typically delivered in about 21 days. IMDs can cause developmental delays, other serious medical problems, and even death if they are not controlled. Diagnosis is essential, but often difficult because of the diversity of metabolic pathways involved.
Current diagnostic procedures are based on a time-consuming series of segmented biochemical tests that can take months to provide results. Meta IMD is an adjunctive, first-line clinical test that can save time to diagnosis by simultaneously surveying individual metabolites and pathways across amino acids, carbohydrates, organic acids, fatty acids, neurotransmitters, nucleotides and bile acids to detect biochemical abnormalities linked to IMDs.
“When a patient has a suspected inherited metabolic disorder, it’s critical that a physician is able to make a quick, accurate diagnosis to get that patient on the correct treatment,” said John Ryals, Ph.D., president and CEO at Metabolon. “Our Meta IMD test comprehensively surveys hundreds of metabolites associated with many IMDs to speed the process. A 250 microliter plasma sample provides specific information to assist the physician in deciding what additional clinical tests are needed to confirm or clarify a diagnosis. Meta IMD is the newest addition to our growing portfolio of Precision Medicine products that are evolving from our metabolomics technology. Within two years, we hope to expand the coverage to over 100 different IMDs using this small sample size.”
Meta IMD should be considered for individuals with developmental delay, seizures, suspected autism spectrum disorder, failure to thrive, low blood sugar, recurrent vomiting, speech and/or language delay, poor muscle tone, as well as an undifferentiated phenotype possibly related to a biochemical pathway indication.
About Inherited Metabolic Disorders
IMDs, also known as inborn errors of metabolism, are rare genetic disorders that result in metabolism problems in which the body cannot properly turn food into energy. The disorders are usually caused by defects in specific proteins (enzymes) that help break down various nutrients in food. Other IMDs are caused by missing or low levels of necessary substances.
Generally, IMDs represent a group of about 500 rare genetic diseases that collectively occur in about one out of 2,500 people. Presentation of an IMD is usually in the neonatal period or infancy, but can occur at any time, even in adulthood. Some metabolic disorders are indicated by routine newborn screening tests, while others are identified only after a child or adult shows symptoms of a disorder.
Metabolon, Inc. is the world’s leading health technology company focused on the use of metabolomics in precision medicine and life sciences research. This powerful tool for assessing health is based on proprietary platforms and informatics that deliver biomarker discoveries, innovative diagnostic tests, and ground-breaking partnerships in genomics-based health initiatives. Metabolon’s expertise is also accelerating research and product development across the pharmaceutical, biotechnology, consumer products, agriculture and nutrition industries, as well as academic and government organizations. The company was founded in 2000 and is headquartered in Research Triangle Park, North Carolina. For more information, please visit www.metabolon.com or follow us on LinkedIn or Twitter.
Cautionary Note about Forward-Looking Statements
The materials provided herein that are not historical facts are or might constitute projections and other forward-looking statements regarding future events that involve substantial risks, uncertainties and assumptions. If any of these risks or uncertainties materialize, or if any of these assumptions prove to be incorrect, Metabolon’s results could differ materially from the results expressed or implied by any forward-looking statements. The risks, uncertainties and assumptions referred to above include, but are not limited to: the uncertainties inherent in biochemical research and development; decisions by regulatory authorities regarding whether and when to approve diagnostic tests; the clinical utility of Metabolon’s metabolomic services; Metabolon’s and its distributors’ ability to successfully commercialize and market both new and existing products; governmental laws and regulations affecting health care, including access, pricing and reimbursement of diagnostic tests; the strength of Metabolon’s intellectual property portfolio; Metabolon’s history of operating losses; whether Metabolon is able to achieve or sustain profitability; its highly competitive industry; its ability to compete effectively; security and privacy risks; and Metabolon’s ability to continue to innovate and provide products and services that are useful to its clients, among other risks, uncertainties and assumptions.
Vice President, Corporate Communications & Investor Relations
Record changed: 2016-10-20
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