Alfigen, Inc. Offers Most Extensive Preimplantation Genetic Diagnosis Test Commercially Available.

Business Editors/Health/Medical Writers

PASADENA, Calif.--(BUSINESS WIRE)--Oct. 13, 2003

New Test Evaluates Numerical Chromosome Abnormalities for Ten (10)

Chromosomes in Embryos Prior to In Vitro Fertilization Implantation

Alfigen, Inc., The Genetics Institute, one of the largest private genetics diagnostic laboratories in the country, announced today the availability of a proprietary ten (10)-probe panel for preimplantation genetic diagnosis (PGD) to detect specific numerical chromosomal abnormalities of in vitro fertilization embryos prior to implantation. This information may allow the in vitro fertilization (IVF) specialist to select the best embryos for transfer and avoid those embryos destined to fail to implant, spontaneously abort, or result in abnormal live births. Alfigen's probe panel was specifically designed based on over twenty years of experience with chromosome analysis of spontaneous abortions.

Alfigen's experience with cytogenetic analysis of products of conception shows that the chromosomes most often involved in numerical abnormalities are, in decreasing order: 16, X, 21, 22, 15, 13, 18, 9, 8, and Y. 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 years. PGD identifies the embryos with these chromosome abnormalities, thereby avoiding their transfer during an in vitro fertilization procedure.

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 can be tested with the standard five-probe panel or with the new proprietary ten (10)-probe panel, which identifies the number of copies of chromosomes 8, 9, 13, 15, 16, 18, 21, 22, X, and Y.

"We are excited to offer women undergoing PGD the most extensive testing for numerical chromosome abnormalities clinically available. This will increase the probability of a successful pregnancy outcome from their in vitro fertilization procedure," said E. Robert Wassman, M.D., Vice President of Clinical Services for Alfigen, Inc. Other probe combinations defined by the IVF specialist for their specific purposes can also be performed at Alfigen.

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.

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.

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 physicians 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. Alfigen's 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. The professional staff of Alfigen are Board Certified in genetics, cytogenetics, or molecular genetics and are licensed to perform genetic testing in California. 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.