May 20, 2005

Gross Deletion Detection Now Available with The Ambry Test for Cystic Fibrosis

IRVINE, CA (May 20, 2005) – AMBRY GENETICS, a worldwide leader in genetic testing, announced it has introduced a valuable enhancement to its Cystic Fibrosis molecular testing menu. The Ambry Test: CF AMPLIFIED can now detect gross deletions, increasing the detection rates of genetic abnormalities that can cause CF. Gross deletions for CF have been commercially undetectable until now.

“This is the next obvious step in improving the molecular diagnosis of CF—but no one had been able to bring it to market,” said Charles Dunlop, Chief Executive Officer of Ambry Genetics. “I am proud that our research department has made us the first company to provide the clinical market with this breakthrough technology and offer health care professionals a higher level of resolution in their diagnosis,” continued Dunlop.

The Ambry Test™: CF and The Ambry Test: CF AMPLIFIED combine scanning and sequencing technologies to analyze a gene’s entire coding region plus surrounding critical introns. The tests provide the most comprehensive analysis of the CFTR gene currently available, scanning for the more than 1,300 known mutations rather than simply identifying 25 to 100 specific mutations. Gross deletion testing can aid in those cases when full gene sequence analysis has not resulted in a conclusive diagnosis. “We have gone beyond the single nucleotide with the addition of our gross deletion detection assay,” states Anja Kammesheidt, Chief Scientific Officer of Ambry Genetics. “In our ongoing efforts to advance our specialized genetic tests, this type of analysis will help to close the diagnostic gap in many difficult unresolved cases.”
Gross deletions comprise a significant percentage of mutations causing CF. Since Ambry Genetics’ new deletion assay may solve more patient dilemmas by providing a complete explanation, Ambry Genetics is offering to retest individuals, when appropriate, at a reduced cost. From now through the end of August, patients who have previously had their DNA analyzed by the Ambry Test: CF can be tested for gross deletions for $250. Clients who have submitted DNA within the past thirty days do not have to submit another sample. Samples sent prior to the past thirty days do require another sample submission. Ambry Genetics provides free sample submission kits including free shipping, the convenience of medical insurance billing and institutional billing. Medicaid is accepted from several states.

CF affects approximately one in every 3,000 individuals in the United States, making it one of the most common inherited disorders.

AMBRY GENETICS

Ambry Genetics is a worldwide leader in specialized genetic testing. The proprietary Ambry Test™ combines scanning and sequencing technologies to analyze a gene’s entire coding region plus surrounding critical introns. Capable of identifying approximately 99% of all disease-causing mutations of the CFTR gene, the company’s reputable Cystic Fibrosis test has an unrivaled detection rate across all ethnic groups. The Company also created the world’s first and only comprehensive genetic test for three principal genes (PRSS1, SPINK1 and CFTR) associated with Chronic and Hereditary Pancreatitis. Ambry Genetics is striving to lessen inherited diseases and is committed to providing the basis for more effective treatments and targeted prevention through molecular understanding. Headquartered in Irvine, California, the Company’s advancements are providing precise, cost effective methods to aid in disease definition and early, more accurate diagnosis. Several academic and pharmaceutical research projects are underway, including expanded population statistical analysis and the development of assays for other genes. Ambry Genetics is a CAP accredited laboratory. Website: www.ambrygen.com.