Alfigen, Inc. Offers Preimplantation Genetic Diagnosis - PGD; New test detects genetic abnormalities in embryos prior to in vitro fertilization implantation.

Business Editors/Health/Medical Writers

PASADENA, Calif.--(BUSINESS WIRE)--Oct. 11, 2002

Alfigen, Inc., The Genetics Institute, one of the largest private genetics diagnostic laboratories in the country, announced today that Preimplantation Genetic Diagnosis has been added to its list of laboratory services. Expanding upon its unsurpassed experience with prenatal cytogenetics and FISH (fluorescent in situ hybridization) procedures, Alfigen's services now enable any assisted reproductive technology program to provide Preimplantation Genetic Diagnosis (PGD) as a routine laboratory test to their patients. Using state of the art tools including automated microscopes and a computerized imaging system Alfigen has created the capacity to apply Preimplantation Genetic Diagnosis to the detection of aneuploidies and unbalanced chromosome translocations. PGD is an invaluable aid in selecting the most genetically viable embryos for implantation at each cycle.

PGD for detection of aneuploidies and unbalanced translocations utilizes fluorescent in situ hybridization (FISH) in which a DNA probe that is coupled with a colored fluorescent marker is hybridized to the DNA in the test sample. The test sample for PGD is a single cell that is removed from an in vitro fertilized embryo at the eight-cell cleavage stage by an embryologist. Often, the embryologist will biopsy multiple embryos. The cell from each of the multiple embryos is tested routinely with FISH probes specific to chromosomes 13, 18, 21, X, and Y. They represent the clinically most significant numerical chromosome abnormalities. The risk of numerical abnormalities of chromosomes, known as aneuploidy, increases with age and is therefore an issue for many women attempting to become pregnant after age 35. PGD identifies the embryos with these chromosome abnormalities thereby avoiding their transfer in an in vitro fertilization procedure.

"Elimination of embryos with randomly occurring, age related, or familial chromosomal abnormalities by fast, accurate FISH screening both decreases the loss of chromosomally abnormal fetuses throughout the first trimester and also decreases the likelihood of difficult, heart wrenching decisions when definitive prenatal diagnosis is performed later in the pregnancy," said E. Robert Wassman, M.D., Vice President of Clinical Services for Alfigen, Inc.

When a parent is a known carrier of a balanced translocation, PGD can be used to assure that in vitro fertilized embryos are free of an unbalanced chromosome constitution resulting from the parental translocation. Translocation analysis typically requires FISH and chromosome testing of the parents in addition to a custom two-probe FISH panel analysis on the PGD specimen.

Alfigen is also unique in its ability to provide customized genetic screening and educational materials as well as patient consultations with board certified genetic counselors and geneticists to aid in this process. Alfigen's genetic counselors are trained and experienced in the special needs of patients undergoing in vitro fertilization and prenatal diagnosis.

Traditional prenatal diagnosis is strongly recommended as an adjunct to all pregnancies in which PGD has been performed due to its greater sensitivity and specificity for chromosomal abnormalities, and broader diagnostic range. Chorionic villus sampling (CVS) at around 10-11 weeks of gestation, or amniocentesis at 14 to 18 weeks are options available at Alfigen.

Other pregnancy related testing including first trimester prenatal screening between 11 and 14 weeks and second trimester maternal serum screening between 15 and 20 weeks is also available at Alfigen. Alfigen's staff has pioneered areas of prenatal screening by serum biochemistry and DNA testing to better assist in clarifying causes for recurrent pregnancy failure and guidance during assisted reproductive efforts.

Alfigen, Inc. was founded in 1981 by Omar S. Alfi, M.D. as the first private full service cytogenetics laboratory in the country. It has since grown tremendously both in specimen volume and scope of services to become one of the largest independent genetics laboratories serving the medical community nationally and internationally. The state-of-the-art laboratory offers a full range of complex genetic tests, including cytogenetics (prenatal, postnatal, cancer), fluorescence in situ hybridization (FISH), molecular diagnostics, clinical chemistry, and flow cytometry. The mission -- to provide the highest quality and standards in clinical genetic services with efficient turn around time, cost-effective pricing, and personalized service -- is reflected in all aspects of the company's work. Alfigen's success is based on its commitment to quality and dedication to building long-term relationships with its clients. Alfigen is accredited by CAP and certified by CMS under CLIA. Alfigen is licensed in California, Florida, Maryland and New York. Alfigen is also certified by the State of California Department of Health Services Genetic Disease Branch as a Prenatal Diagnostic Center, operating accredited satellite facilities throughout the state. For more information, visit www.alfigen.com.