Tuesday, December 10, 2019

Roche Molecular Systems’ cobas vivoDx MRSA Gets FDA Approval

The US Food and Drug Administration (FDA) has granted marketing approval for Roche Molecular Systems’ cobas vivoDx MRSA, a diagnostic test that detects colonisation of Methicillin-resistant Staphylococcus aureus (MRSA) bacteria.

In contrast to conventional culture-based techniques, the cobas vivoDx MRSA diagnostic test uses new technology for rapid detection of bacterial colonisation of MRSA, a common cause of hospital-acquired infections.

FDA’s Center for Devices and Radiological Health Office of In-vitro Diagnostics and Radiological Health director Tim Stenzel said: “Diagnostics that are able to provide accurate results more quickly can offer health care providers an advantage when trying to prevent and contain the spread of resistant bacteria.

“Today’s authorisation adds a new tool in the fight to prevent and control MRSA in high-risk settings. The FDA remains committed to supporting efforts to address antimicrobial resistance in order to better protect patients against this ongoing public health challenge.”

In the US, nearly 5% of hospitalised patients carry the MRSA bacteria, according to the Centres for Disease Control and Prevention (CDC).

CDC considers MRSA as a severe antimicrobial-resistant threat. If infections develop, they can be challenging to treat as they are resistant to conventional antibiotics.

According to the CDC estimates, more than 323,000 MRSA cases in hospitalised patients, as well as 10,000 deaths in the US.

cobas vivoDx MRSA leverages bacteriophage technology based on bioluminescence to evaluate MRSA from nasal swab samples.

The test evaluates the MRSA bacterial colonisation within five hours, compared to two days through the conventional culture method.

Designed to aid in the prevention and control of hospital-acquired MRSA infections, the cobas vivoDx MRSA test will be to identify patients who require enhanced precautions and decolonisation efforts.

The FDA reviewed the test through the de novo premarket review pathway.

QuantuMDx and Ontera Collaborate to Advance Sepsis Diagnosis

QuantuMDx Group Limited and Ontera, Inc have announced a collaboration to create a next-generation solution for blood stream infection and drug resistance detection. The technology will be based on QuantuMDx’s rapid cell/sample preparation technology, Capture-XT® and Ontera’s powerful nanopore biosensor, currently utilized in their SAM and DUO Nano platforms.

The combined technologies should enable clinicians to quickly interrogate blood specimens of those presenting with sepsis signs and symptoms, allowing guided ‘right first time’ care management, at the bedside.

Sepsis affects more than 30 million people worldwide every year leading to an estimated 6 million deaths.¹  If it’s not recognized early and managed promptly with targeted antibiotics, sepsis can lead to septic shock, multiple organ failure and death.

QuantuMDx’s revolutionary Capture-XT® technology captures, concentrates and enriches targeted pathogens from a large sample volume, quickly enabling visual diagnosis and downstream utilization, such as drug-susceptibility analysis, PCR, NGS and now nanopore detection, with this collaboration.

Ontera’s single pore platform provides fast amplification of multiple bacterial targets, differentiation between antibiotic resistant and susceptible strains. The company uses silicon nanopore for in-minutes quantitative measurement of nucleic acids, proteins and small molecules, avoiding time-consuming laboratory procedures that can delay lifesaving, fast and precise treatment.

“Sepsis is one of the hardest diseases to detect. It’s like looking for a needle in a haystack, due to the low concentration of organisms in the blood stream that cause disease,” says Jonathan O’Halloran, Chief Scientific Officer at QuantuMDx. “Our early prototype testing has already shown sensitivity in the range required for this kind of test and performed in minutes from spiked bacteria in whole blood. We haven’t even pushed the technology yet, but it has the potential to become a paradigm-shifting, powerful device. And, by including drug resistance in the assay to enable right first time prescribing, the impact of this partnership could be profound.”

“Today, 30% of patients receive inappropriate antimicrobial therapy. By not only identifying sepsis but also resistance to most common antibiotics in less than 30 minutes, we will transform the sepsis landscape and impact lives,” says Murielle Thinard McLane, CEO of Ontera. “We have set out on a mission to democratize access to molecular information to create a more sustainable planet. This collaboration with QuantuMDx is a major proof point along that mission.”

Reference: WHO 2019