Recent FDA clearances bring important breakthroughs to US market

By Steve Michalik, Claire Barresi, Jérôme Fogarolo, Virginie Giroudon, and Karen Pinkston

Regulatory approvals, as you are aware, are an important step in bringing products to market. A device that is labelled as CE-marked has met the required safety standards set by the European Union and may therefore be sold in Europe. In the United States, the FDA (Food and Drug Administration) reviews medical devices for safety and efficacy. FDA clearance is therefore an essential prerequisite to commercializing a medical device in the US. bioMérieux is pleased to announce that labs in the US will now have available three new FDA cleared products :

• VITEK^® MS V3 knowledge base (KB) V3.0 software update
• BACT/ALERT^® VIRTUO^® - automated instrument for blood culture detection
• RAPIDEC^® CARBA NP - for qualitative detection of carbapenemase-producing organisms

VITEK^® MS V3 

In July 2017, VITEK^® MS V3 became the first MALDI-TOF¹ mass spectrometry system to receive FDA 510(k) clearance for the identification of mycobacteria, Nocardia, and moulds. These difficult-to-identify organisms usually require days or even weeks of specific culture conditions for appropriate growth, along with subsequent advanced tests for reliable identification at the species level.

The updated software for VITEK^® MS, however, now offers safe, simple and reliable identification of these pathogens in minutes². This provides clinicians with actionable results to manage infections such as tuberculosis, lung and bone infections, and other serious organ infections caused by these organisms. The system works with ready-to-use inactivation and extraction kits, which are also FDA cleared and CE-marked. The new FDA clearance expands the available database with 78 species:

• 19 mycobacteria including Mycobacterium tuberculosis (TB) group and the most frequent non-tuberculous mycobacteria (NTM)
• 12 Nocardia
• 47 moulds, including the most medically important

The VITEK^® MS system’s new database and reagent kits are now commercially available in the US as well as countries which recognize CE-marking.

BACT/ALERT^® VIRTUO^®

The BACT/ALERT^® VIRTUO^® automated blood culture microbial detection system received FDA 510(k) clearance in March 2017, making it available in the US market, in addition to countries that recognize CE-marking. 

BacT/ALERT^® VIRTUO^® is the first microbial detection system for blood culture to offer “Load & Go” technology, helping labs streamline their workflow. It offers powerful new proprietary algorithms for earlier microbial growth detection. This enhancement provides more rapid time to detection, and therefore faster identification of bloodstream infections^3,4,5,6,7,8. BacT/ALERT^® VIRTUO^® offers an integrated configuration with scalable incubation capacity from 428 to 1,712 bottles.

The system works with BACT/ALERT^® FAN^® Plus media, which are formulated to optimize antibiotic neutralization with optimal growth performance of microorganisms, although other BACT/ALERT^® culture media can be used. A unique blood level detection technology measures the blood volume in each blood culture bottle at the time of loading. This helps laboratories monitor that the recommended blood volume was collected, which is a crucial factor in detecting bloodstream infections.

Faster detection of pathogens with VIRTUO^® provides critical information to help optimize patient treatment, especially in life-threatening conditions such as sepsis.

RAPIDEC^® CARBA NP

RAPIDEC^® CARBA NP received FDA 510(k) clearance in April 2017, and is now commercially available in the US as well as in countries that recognize CE-marking. 

RAPIDEC^® CARBA NP is a phenotypic (colorimetric) test that is used for the qualitative detection of carbapenemase-producing Enterobacteriaceae and Pseudomonas aeruginosa⁹. It is based on the Carba NP test principle described by Nordmann, Poirel and Dortet^{10, 11}.

Carbapenemases are β-lactamases that are capable of inactivating most existing β-lactams. Their spread among Gram-negative bacilli is a major public health concern because they exhibit extensive resistance and spread rapidly worldwide. There is a high mortality risk for patients infected with carbapenemase-producing strains. Therefore, rapid detection is of utmost importance to determine appropriate treatment for reducing the risk of primary and secondary infection, and to be able to implement infection prevention measures to curb the spread within healthcare institutions. 

Dr Poirel recently gave a live interview on Carbapenemase-resistance at ECCMID 2017:

References:

1. MALDI-TOF : Matrix Assisted Laser Desorption Ionization – Time Of Flight
    
2. Mather, C.A., et. al. Comparison of the Bruker Biotyper and Vitek MS Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry Systems for Identification of Mycobacteria Using Simplified Protein Extraction Protocols. J. Clin. Microbiol. 2014, 52(1):130.

3. LIOTTI, FM. et. al. “Laboratory Evaluation of the BacT/ALERT^® VIRTUO^® Automated Blood Culture System”. ECCMID 2016 poster EP0958.

4. MENCHINELLI, F. et. al,. “BacT/ALERT^® VIRTUO: a New Automated Colorimetric Microbial Detection System for Detection of Bacteremia”. AMCLI 2015 Poster.

5. MULLIS, D. et al. “Comparison of the bioMérieux Virtuo BacT/Alert Microbial Detection System to the BacT/Alert 3D”. Dublin 2016 Poster.

6. CHAN, Y-J. et. al. “Comparison of the new generation of blood culture system with the BacT/ALERT^® 3D system for the detection of bacteremia in patients from emergency room.” ECCMID 2016 Poster.

7. CONGESTRI, F. et. al. “Comparison of ‘time to detection’ values between BacT/ALERT VIRTUO and BacT/ALERT 3D instruments for clinical blood culture samples.” Int. J. Infect. Dis., 2017, vol. 15, n°62, 1-5.

8. ALTUN, O. et. al. “Controlled evaluation of the new BacT/ALERT VIRTUO blood culture system for detection and time to detection of bacteria and yeast.” J. Clin. Microbiol., 2016, vol. 54, n°4, 1148-1151.

9. RAPIDEC^® CARBA NP has US FDA clearance for Enterobacteriaceae and Pseudomonas aeruginosa, is CE marked for Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii.

10. NORDMANN P., POIREL L., DORTET L. Rapid detection of carbapenemase-producing Enterobacteriaceae. Emerging Infectious Diseases, www.cdc.gov/eid, 2012, vol. 18, n°9, 1503-1507.

11. DORTET L., POIREL L., NORDMANN P. Rapid identification of carbapenemase types using a biochemical test in Enterobacteriaceae and Pseudomonas. Antimicrobial. Agents Chemother., 2012, vol. 56, n°12, 6437-6440.