Business Wire - November 30, 2004
The ACCURUN 315 HIV-1 RNA Positive Quality Control includes a series of five controls, each with a different level of HIV RNA, and is the first product cleared for use in the U.S. as an independent control for both diagnostic testing and blood screening. BBI Diagnostics has also obtained CE Mark approval for ACCURUN 315, a regulatory requirement for sales to European markets. With the FDA clearance, BBI Diagnostics may now sell the same product worldwide, generating manufacturing and operational efficiencies.
SeraCare also announced that its ACCURUN 345, which includes HIV-1 RNA, Hepatitis C Virus (HCV) RNA, and Hepatitis B Virus (HBV) DNA in a single control, and its ACCURUN 803, the corresponding negative control, have received FDA 510(k) clearance. These products are designed to perform quality control for the tests that blood banks and plasma centers use to screen donors.
HIV-1 RNA is the genetic material of the HIV-1 virus, the causative agent of AIDS. Highly sensitive quantitative tests such as those for HIV-1 RNA are used to measure virus levels in blood to help physicians diagnose and monitor infection. U.S. blood banks test every unit of donated blood with RNA tests before transfusion to help safeguard the blood supply. ACCURUN controls assist laboratories to detect and prevent errors during these critical blood tests.
"BBI Diagnostics has long been a leader in providing quality control materials for vital laboratory testing," said Michael F. Crowley, Jr., President and CEO of SeraCare Life Sciences. "These ACCURUN products are further examples of our commitment to support clinical and blood bank laboratories worldwide in the fight against AIDS and other infectious diseases. ACCURUN 345 is particularly noteworthy because it currently is the only FDA-cleared RNA/DNA control that combines the HIV and Hepatitis B and C viruses in a single specimen, providing both cost and convenience benefits to these important laboratories."
The BBI Diagnostics division of SeraCare provides products and services for the detection of infectious diseases such as AIDS, Lyme Disease and Viral Hepatitis, and has a complete line of quality control materials for infectious disease testing.
About SeraCare Life Sciences:
SeraCare Life Sciences, Inc. is a manufacturer and provider of biological products and services for diagnostic, therapeutic, drug discovery, and research organizations worldwide. The Company's offerings include plasma-based therapeutic products, diagnostic products and reagents, cell culture products, specialty plasmas, in vitro stabilizers, and the Global Repository(R), comprised of clinical samples (DNA, RNA, tissue, and serum) for the application of human genetics to target validation for drug discovery. SeraCare is headquartered in Oceanside, CA and maintains facilities in Cambridge and West Bridgewater, MA; Frederick and Gaithersburg, MD; and Hatboro, PA. SeraCare is publicly traded on the NASDAQ national stock market under the symbol SRLS. For more information please visit www.seracare.com or divisional websites at www.bbii.com and www.getdna.com.
Safe Harbor For Forward Looking Statements:
Certain statements contained in this press release may be deemed to be forward looking statements under federal securities laws, and the Company intends that such forward looking statements be subject to the safe harbor created thereby. The Company cautions that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by the forward looking statements. Information on factors that could affect the Company and its financial results is included in the Company's report on Form 10-K for the year ended September 30, 2003 filed with the Securities and Exchange Commission (SEC) as well as the Company's other periodic filings with the SEC. The Company undertakes no obligation to publicly update or revise any forward looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Jaffoni & Collins Incorporated David Collins, Carol Young 212-835-8500 or srls@jcir.com
SOURCE: SeraCare Life Sciences, Inc.
041130
BW041119
Copyright © 2004 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .