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Focus Diagnostics, Inc. Announces Release Of Novel Genetic Interpretive Services - GenomEx(TM)



11/4/2005 12:38:50 PM

HERNDON, Va., Nov. 3 /PRNewswire/ -- Today Focus Diagnostics announced the release of GenomEx(TM), a novel genetics interpretive service that provides personalized interpretation and comprehensive reporting for complex genetic carrier testing. This new service is ideal for hospitals and commercial laboratories capable of conducting genetics testing that do not have access to a board-certified clinical molecular geneticist to provide personalized revised risk assessments and clinical consultation. The first GenomEx(TM) interpretive service is for cystic fibrosis (CF). Interpretive services for other genetic diseases will be added in the future. The platform-neutral GenomEx(TM) CF interpretive service combines personal risk information (personal history, family history, and ethnicity) with mutation/variant test results (provided by the performing laboratory) to generate personalized revised carrier risk assessment reports that are reviewed and released by a board-certified clinical molecular geneticist. Information is transmitted via Focus Link(R), a secure web-based test ordering and result delivery system. Focus Diagnostics' Human Genetics department is directed by Jean Amos Wilson, Ph.D. FACMG, a board-certified Clinical Molecular Geneticist. Focus has filed a patent application for its GenomEx(TM) interpretive service.

"Expansion into the area of human genetics is a natural extension of Focus' molecular diagnostics expertise in pathogen genotyping and mutation analysis. It represents for us an important progression from pathogen-centric to patient-centric diagnostics," states Charles C. Harwood, Jr., CEO of Focus Diagnostics. "GenomEx(TM) utilizes both our genetic expertise and our experience with healthcare data and information transfer solutions. It will allow an ever increasing number of laboratories conducting CF testing to provide a better understanding of revised carrier risk information to help physicians and patients make informed decisions."

CF mutation analysis, once performed by only the largest commercial laboratories, is quickly being adopted by mainstream laboratories as more diagnostic products become available and as demand for testing increases. Accurate interpretation of CF test results, most especially negative results, requires careful interpretation of complex data. "GenomEx(TM) provides laboratories - who would not otherwise have it - access to clinical molecular board-certified geneticists, and thereby the ability to provide proper revised risk assessments to their physicians, which is very important to proper medical management and personal decision making," comments Jean Amos Wilson, Ph.D.

Cystic fibrosis is one of the most common genetic diseases in the Caucasian population. Approximately 1 in every 25 Caucasians is a carrier for this recessive condition and 1 in 2500 are clinically affected. In 1997 the National Institute of Health (NIH) recommended that all couples that are pregnant or are considering pregnancy, particularly those in high-risk populations, be offered carrier screening for cystic fibrosis. In 2001 the American College of Medical Genetics (ACMG), the American College of Obstetricians and Gynecologists (ACOG), and the National Human Genome Research Institute (NHGRI) recommended that CF carrier screening be offered to all Caucasian couples that are pregnant or considering pregnancy. It is estimated that over 2 million CF tests are conducted annually in the US.

About Focus Diagnostics, Inc.

Focus Diagnostics has served the healthcare community for nearly three decades as an innovative developer and provider of testing services and products for complex diagnostics, including infectious disease, autoimmune and newly introduced genetic testing. Focus Diagnostics' USFDA-registered and ISO 9001-certified diagnostics manufacturing facility and ISO 9001-certified reference laboratory are located in Cypress, California. Corporate headquarters are in Herndon, Virginia and Focus' Pharmaceutical Diagnostics Group, known as Focus Bio-Inova, is located in Herndon, Virginia and Plasir, France. For additional information about Focus Diagnostics, visit http://www.focusdx.com

Focus Diagnostics, Inc.

CONTACT: Mary Kay Mosch of Focus Diagnostics, +1-410-832-7575,mkmosch@focusdx.com


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