Now Available for Antimicrobial Susceptibility Testing, Dalbavancin on FDA-Cleared Microbroth Dilution Susceptibility Plate
The antimicrobial dalbavancin represents one of the latest treatment options for skin infections and is now available on FDA-cleared microbroth dilution susceptibility plates, giving microbiology laboratories the means for susceptibility testing for fastidious Gram-positive organisms that cause acute bacterial skin and skin structure infections (ABSSSIs) in adults.
The Thermo Scientific Sensititre ID/AST System is the first to offer dalbavancin on IVD-labeled, microbroth dilution susceptibility plates. With one of the largest, most up-to-date selections of FDA-cleared antimicrobials, the Sensititre System enables laboratories to utilize dalbavancin, and over 240 other antimicrobials, to create custom plates tailored to their formulary, dilutions and patient population, eliminating offline tests and reducing costs. Dalbavancin is currently available on Sensititre custom plates, with plans to feature it on new standard plates in the future.
“The addition of dalbavancin to our antimicrobial offering is an important one for clinicians struggling to treat patients suffering from serious skin infections, particularly those that have shown resistance to other drugs,” said Mario Gualano, president, Thermo Fisher Scientific Microbiology. “By making this new compound widely available on the Sensititre platform, clinicians have another option in making decisions for the effective treatment of patients.”
The Sensititre System utilizes true minimum inhibitory concentration (MIC) results, which are essential to fighting antimicrobial resistance by providing greater sensitivity for better resistance tracking. True MIC results are also the best measure of antibacterial effect, which can assist with therapeutic choices and promote overall better patient care.
Dalvance for injection (dalbavancin, Durata Therapeutics, an affiliate of Allergan, plc) is approved by the FDA for the treatment of adults with skin infections caused by fastidious Gram-positive organisms, including: Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus). It is the first drug with the Qualified Infectious Disease Product (QIDP) designation to receive FDA approval.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance