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June 1, 2005
CLEP OF NEW YORK GRANTS AMBRY GENETICS
CERTIFICATION STATUS
IRVINE, CA (June 1, 2005) – AMBRY GENETICS
announced it has met all quality standards to accept clinical
specimens obtained in New York State for Cystic Fibrosis
genetic testing. The approval was granted by the Clinical
Laboratory Evaluation Program (CLEP) of the Wadsworth Center.
In 1965, New York became the first state in the nation to
initiate a certification and licensing program for a limited
number of clinical laboratories operating within the state in
selected areas of patient testing.
CLEP monitors the overall quality of testing
conducted by permit-holding clinical facilities and provides
guidelines, quality control standards and procedures to be
used. The program seeks to ensure the accuracy and reliability
of results of laboratory tests on specimens obtained within
the state through on-site inspections, proficiency testing and
evaluation of the qualifications of personnel. CLEP currently
issues permits to approximately 1,000 laboratories and 600
patient service centers in New York State on an annual basis.
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.

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