BD Receives CLIA ‘Moderate Complexity’ Status for the BD MAX(TM) GBS Assay
BALTIMORE, Aug. 3 /PRNewswire-FirstCall/ — BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that it has received “Moderate Complexity” status from the U.S. Food and Drug Administration, under the Clinical Laboratory Improvement Amendments (CLIA), for the BD MAX(TM) GBS Assay for Group B Streptococcus (GBS) on the BD MAX(TM) System. With the “Moderate Complexity” categorization, the BD MAX GBS Assay will increase access to cost effective molecular testing for a broad range of laboratories performing GBS screening.
“A shortage of highly skilled lab workers continues to challenge laboratories striving to deliver more advanced molecular testing in a cost-effective manner,” said Philippe Jacon, President, BD Diagnostics – Diagnostic Systems. “We designed the BD MAX GBS Assay with those laboratories in mind providing them with a simplified, cost-effective molecular testing platform.”
The U.S. Centers for Disease Control and Prevention (CDC), in collaboration with the American Congress of Obstetricians and Gynecologists (ACOG) and other organizations, is updating guidelines for the prevention of neonatal GBS disease. A new provisional recommendation was recently published which includes polymerase chain reaction (PCR) from Lim broth as an option for antenatal screening.
The BD MAX GBS Assay is the only fully automated PCR method with a Lim broth claim. PCR on Lim broth provides a high level of sensitivity and rapid results for detecting GBS. With the added benefit of a CLIA “Moderate Complexity” rating, the BD MAX GBS Assay is an efficient and effective option for laboratories looking to convert their GBS testing to a molecular method. The BD MAX GBS Assay is the first offering in a broad menu of infectious disease tests under development for the BD MAX System.
GBS remains one of the leading causes of morbidity and mortality among newborns, with maternal colonization serving as a major risk factor for early onset GBS disease. However, it is preventable with antibiotics administered to the mother during labor. The current standard of care for preventing neonatal GBS disease is screening pregnant women at 35 to 37 weeks of gestation using culture methods, which are limited by sensitivity, turnaround time and the need for highly trained technologists to interpret the results.
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people’s health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.
Contact: -------- Alyssa Zeff Public Relations (201) 847-4358 Alyssa_Zeff@bd.com
SOURCE BD-Becton Dickinson