Roche Diagnostics Conducts Workshop for America's Blood Centers on Screening Plasma Pools for Human Parvovirus B19 and Hepatitis A Virus.

Business Editors and Health/Medical Writers

PLEASANTON, Calif.--(BW HealthWire)--Aug. 14, 2001

Roche Molecular Diagnostics (RMD), the business area of Roche Diagnostics responsible for developing nucleic acid based tests to screen blood and plasma, announced the completion of a workshop for screening plasma pools for Human Parvovirus B19 and Hepatitis A virus. The workshop was held in conjunction with members of America's Blood Centers (ABC), whose network of community blood centers are currently participating in Roche Diagnostics' clinical studies. The studies are being conducted under an FDA approved Investigational New Drug program, using the Roche COBAS AmpliScreen HCV Test, v2.0 and COBAS AmpliScreen HIV-1 Test, v1.5.

Participants of the workshop also reviewed the status of ongoing donor screening trials for the HCV and HIV-1 tests. The workshop was part of Roche's recently announced investment in the blood screening area. "We are totally committed to our blood screening program," noted Heiner Dreismann, President of Roche Molecular Diagnostics. Roche Diagnostics' PCR blood screening tests for HIV-1 and HCV are already licensed for commercial use in France, Spain and Australia. In addition, Roche's COBAS AmpliScreen Hepatitis C Test was approved by the Italian regulatory authorities last March. Dreismann continued: "We are now working intensively on regulatory activities in the United States, Germany and Canada, and are focused on bringing our products to market as soon as feasible. Our commitment is serious and long-term."

The purpose of the recent workshop was to define the specifications for additional tests that could reduce the risk of transmission of Parvovirus B19 and Hepatitis A virus by pharmaceutical products derived from large pools of plasma, the liquid part of donated blood. Products such as intravenous immunoglobulins and anti-hemophilic factors are life saving for patients that cannot make these proteins. Parvovirus B19 is a common childhood infection called the "fifth exhantematous disease." It produces a rash that lasts a couple of weeks, and in general is quite benign. However, this disease can produce serious anemia in pregnant women and in people with deficiencies of the immune system such as AIDS patients. Hepatitis A virus is generally benign, but can also produce complications in recipients of plasma products. Today, all plasma products are treated with methods that kill HIV, Hepatitis B and C viruses. However, these methods do not kill non-enveloped viruses like Parvovirus B19 and Hepatitis A. New screening assays using NAT tests could substantially reduce the amount of virus that could contaminate these plasma products, and are expected to reduce the risk of transmission of these diseases to people who depend on plasma products.

"We are pleased to be able to offer benefits such as the ABC workshop to our associates in the blood and plasma screening area," stated Heino von Prondzynski, Member of the Roche Executive Committee and Head of Roche Diagnostics. "Blood screening is without question one of our highest priorities, and we want to support the blood and plasma centers with the resources they need to provide the safest possible blood products to patients in need. Close collaboration with our colleagues in the transfusion medicine community is essential to our commitment of developing an optimal range of testing resources for blood screening laboratories worldwide."

Developed by RMD, the AmpliScreen tests are based on the polymerase chain reaction (PCR). PCR is a nucleic acid testing (NAT) method used to determine the actual presence of infectious agents in the blood, rather than detecting the body's immune response to exposure to disease as is done with serological testing.

NAT screening of blood offers a major advantage. Traditional serological tests detect the patient's antibodies to a viral infection, but these antibodies take time to develop. The time between viral exposure and antibody development is known as the "serologically silent window" period. Even though antibodies are not detectable during this phase, the virus is present in the individual's blood and this blood is able to infect another person. Nucleic acid tests such as the Roche COBAS AmpliScreen assays detect viral material in the blood.

"We are using NAT to test donated blood for Hepatitis C and HIV-1, under a research protocol" noted Paul Holland, MD, Medical Director and Chief Executive Officer of the Sacramento Medical Foundation Blood Centers, an ABC affiliate in California. "Protecting transfused patients from infection is a major concern. NAT testing is one of the tools that makes that possible. Developing ways to detect Parvo B19 and Hepatitis A viruses will protect the blood supply from these viruses in the future."

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people's well being and quality of life. The Group has approximately 64,000 employees and sells its products in over 170 countries. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide. Roche Molecular Diagnostics, a business area of Roche Diagnostics, has made the polymerase chain reaction (PCR) the leading DNA probe technology in the world. PCR technology allows minute amounts of genetic material to be amplified into billions of copies in just a few hours. PCR nucleic acid amplification-based test kits for clinical diagnostics are marketed under the trade name AMPLICOR(R), and blood screening assays under the trade name COBAS AmpliScreen(R) and AMPLINAT(tm) MPX.