German pharmaceutical company CureVac is developing a good manufacturing practice (GMP) compliant ribonucleic acid (RNA) production facility at its headquarters in Tubingen, Germany.
BD Diagnostics is a developer and supplier of reagents, medical devices and instrument systems that aim to improve drug delivery, raise quality, and increase the detection rate and treatment of diseases.
The firm provides medical technologies to a global client base, advancing patient recovery through its laboratories and products. Its reagent systems ensure an accurate and prompt diagnosis of infectious diseases.
BD Diagnostics provides a comprehensive range of molecular testing through BD MAX™, a fully automated bench-top molecular system.
With this versatile device, users are able to carry out protocols and CE / in-vitro diagnostic (IVD) assays simultaneously.
Women’s health and STI disease detection
The BD MAX™ women’s health and sexually transmitted infection (STI) portfolio is made up of the BD MAX™ Vaginal Panel, BD MAX™ CT/GC/TV and the BD MAX™ GBS. These focus on providing accurate, reliable results for clinicians and labs.
The BD MAX™ Vaginal Panel is a microbiome-based polymerase chain reaction (PCR) assay that is market-authorised by the US Food and Drug Administration (FDA). It directly detects bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis, which are three of most common infectious causes of vaginitis.
The BD MAX™ CT/GC/TV is designed to detect prevalent non-viral STIs chlamydia (CT), gonorrhoea (GC) and trichomoniasis (TV) in a single assay.
The BD MAX™ GBS is an automated, real-time PCR method for the detection of group B streptococcus (GBS) from an enriched culture. It simplifies the detection of GBS colonisation in antepartum pregnant women, rapidly identifying the infection following an overnight Lim Broth enrichment.
Enteric disease identification
The BD MAX™ Enteric Bacterial panel is a rapid in-vitro diagnostic test for a qualitative real-time PCR detection of campylobacter (jejuni and coli), salmonella, shigella / enteroinvasive E. coli (EIEC), and Shiga toxin 1 (stx1) or Shiga toxin 2 (stx2) genes found in shiga toxin-producing escherichia coli (STEC), as well as Shigella dysenteriae.
The BD MAX™ Enteric Parasite panel detects giardia lamblia, entamoeba histolytica, and species of cryptosporidium (IVD), three commonly isolated and highly pathogenic parasites that cause gastroenteritis.
The BD MAX™ Enteric Viral panel is a rapid in-vitro diagnostic test for the qualitative real-time PCR detection of norovirus, rotavirus, adenovirus, sapovirus and astrovirus.
Assays for healthcare-associated infections
BD Diagnostics provides a range of assays for advancing the treatment of healthcare-associated infections (HAI).
The BD MAX™ MRSA assay ensures fast and accurate diagnosis of patients with methicillin-resistant Staphylococcus aureus (MRSA).
The range includes:
- The BD MAX™ MRSA XT assay with eXTended Detection Technology provides accurate detection of deoxyribonucleic acid (DNA) from new mec right-extremity junction (MREJ) types, MRSA strains with novel mecC gene, and mecA dropouts in patients at risk for nasal colonisation
- The BD MAX™ Clostridium difficile (Cdiff) assay rapidly detects Cdiff toxin B gene (tcdB) to aid in Cdiff infection (CDI) diagnosis
- The BD MAX™ StaphSR with eXTended Detection Technology locates DNA of strains of MRSA and reduces the risk of producing a false MRSA indication
Screening for colonisation is a key component of carbapenemase-producing organism (CPO) control as the number of individuals with intestinal colonisation far outnumbers the few who develop CPO infection and are detected through clinical cultures.
BD MAX™ Check-Points CPO Assay provides identification common carbapenemase genes KPC, OXA-48 (OXA-48 and OXA-48 like), NDM, VIM and IMP directly from rectal swabs in Enterobacteriaceae and non-fermenters.
Respiratory disease assays
The dual functionality of open systems and CE/IVD capabilities on the BD MAX™ System enables laboratories to perform a broad range of molecular tests on a single workstation. This flexibility provides clinicians with an array of information to help make critical treatment and management decisions to improve patient care.
The Certest Viasure Flu A, Flu B, RSV assay is designed to identify and differentiate between Flu A, B and respiratory syncytial (RSV) in respiratory samples from patients with signs and symptoms of respiratory infection. It is produced by BD’s partner Certest
BD MAX’s Carbapenem-Resistant Enterobacteriaceae RUO is a research-use-only assay designed to detect the KPC, OXA-48, and NDM antimicrobial resistance genes found predominantly in carbapenem-resistant enterobacteriaceae (CRE):
Diagenode Respiratory Bordetella pertussis / parapertussis real-time PCR kit is an aid for diagnosis of Pertussis (Europe only). It also enables a detection of Bordetella parapertussis in nasopharyngeal aspirates, although it should not be used for diagnostic purposes. It is also manufactured by BD partner Diagenode
Simple assay workflow
All BD MAX™ IVD assays follow the same simple workflow, consisting of adding a specimen, snapping-in reagents, loading on the instrument and beginning the run.
BD Diagnostics is a medical technology company that provides diagnostic support for medical product developers. With the motto ‘advancing the world of health’, the company leads inpatient and healthcare worker safety, as well as the technologies that enable medical research and clinical laboratories.
The firm provides innovative solutions to help advance medical research and genomics, as well as enhance the diagnosis of infectious diseases and cancer. Its solutions also improve medication management, promote infection prevention, equip surgical and interventional procedures and help manage diabetes.
BD Diagnostics partners with organisations worldwide to address challenging health issues. It has more than 45,000 associates across 50 countries that work closely with customers and partners to enhance medical outcomes, lower healthcare delivery costs, and expand access to health.