Alpha Therapeutic Obtains First FDA License to Use Polymerase Chain Reaction Testing to Screen Plasma Donations for HIV and Hepatitis C.

Business Editors/Health & Medical Writers

LOS ANGELES--(BW HealthWire)--Sept. 21, 2001

Highly Sensitive Technology Provides Dramatic

Step Forward in Safety of Blood Products

In a landmark advancement for the safety of the nation's supply of plasma derived products, Alpha Therapeutic Corporation today announced it has obtained the first U.S. Food and Drug Administration approval for use of a highly sensitive new testing method for screening plasma donations.

The method was developed by National Genetics Institute, Inc. (NGI) a subsidiary of Laboratory Corporation of America(R) Holdings (LabCorp(R)). Utilizing existing polymerase chain reaction (PCR) technology, this testing method is capable of detecting the presence of human immunodeficiency virus (HIV-1) and hepatitis C virus (HCV) in human plasma donations earlier than currently licensed serologic tests.

A leading producer of plasma derived products, Alpha collects plasma donations from its centers across the United States and processes the plasma into a variety of products to treat life-threatening conditions, including intravenous immune globulin for primary immune deficiencies, coagulation factors for hemophilia and albumin for shock, burns and trauma.

All plasma donations are currently screened for HIV and hepatitis viruses using serologic tests licensed by the FDA. These tests detect either antigens, which are protein components of the virus, or antibodies, produced by the body in response to infection.

PCR can detect very small amounts of the genetic material (ribonucleic acid or RNA) of the viruses themselves. It has the potential to detect a virus earlier in the process of infection, during the "window period" of time before an infected person develops detectable levels of viral antigens or antibodies to the virus. Clinical studies conducted by Alpha and NGI showed that this testing method can detect HIV-1 up to four days earlier than traditional tests and can detect HCV up to 57 days earlier.

All of Alpha's PCR testing is conducted by NGI in Los Angeles, an industry leader in developing novel, highly sensitive polymerase chain reaction (PCR) methods for testing blood borne infectious agents. Alpha recently entered into a laboratory management alliance in which NGI/LabCorp is managing Alpha's serological testing laboratory in Memphis, Tenn.

"We are extremely proud that Alpha is the first company to obtain FDA approval to use this important testing method," said Edward Colton, President & CEO. "It will help increase the safety profile of our plasma products for the patients who use them and will allow for earlier notification of plasma donors with reactive test results.

"This approval further strengthens our relationship with NGI. Their expertise in laboratory testing was vital in helping Alpha achieve this milestone in the safety of plasma products," Colton said.

Alpha obtained a U.S. patent for the "efficient algorithm method" which is used in conjunction with PCR technology to detect viruses in plasma. The complexity of PCR testing makes it difficult to apply to the millions of individual plasma donations collected each year. To make it practical to use this highly sensitive, but logistically complicated procedure for plasma screening, Alpha has patented this method in which samples from up to 512 donations are pooled and tested by PCR. Inventors listed on the patent include Andrew Conrad, Ph.D. and Peter Schmid, M.D. of NGI; and Charles Heldebrant, Ph.D. and Lorraine Peddada, Ph.D. of Alpha.

If a sample pool tests positive, the efficient algorithm is applied to determine the order of further testing, so that reactive samples in the pool can be identified with a minimum of 26 tests, rather than the 512 tests needed to screen each sample individually. Thus, the efficient algorithm provides a way of improving the ability to detect and remove reactive plasma donations and also shortens the time required for PCR screening.

On May 16, 2000, Alpha was granted U.S Patent 6,063,563 for the efficient algorithm method and subsequently entered into a license agreement with NGI, granting NGI the right to use the method in conjunction with PCR testing services it performs.

Alpha is a leading developer of plasma derived biopharmaceutical products including coagulation factors, immune globulin and albumin. Headquartered in Los Angeles, Calif., Alpha is committed to providing high quality, safe and cost effective therapeutics for improved patient care worldwide. Additional company information is available at www.alphather.com.