FDA floats relaxation of regulations to encourage use of mass spectrometry to identify microorganisms

FDA
The FDA thinks the revised regulatory approach can further fuel recent interest in the use of mass spectrometry. (FDA)

The FDA is planning to loosen the regulatory requirements on mass spectrometry devices to increase their use in the identification of microorganisms. Agency officials outlined the plan after signing off on the use of a mass spectrometry device in the identification of the emerging drug-resistant yeast, Candida auris (C. auris).

Under the FDA’s proposals, the first successful filing covering a microorganism identification system process would clear the path for future applicants. The FDA would exempt certain processes covered by these subsequent filings from additional premarket review, enabling companies to more easily gain clearance to sell devices with expanded microorganism identification capabilities.

Sponsored by GenScript

Accelerate Biologics, Gene and Cell Therapy Product Development partnering with GenScript ProBio

GenScript ProBio is the bio-pharmaceutical CDMO segment of the world’s leading biotech company GenScript, proactively providing end-to-end service from drug discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers.

Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health, thinks the revised regulatory approach can further fuel interest in the use of mass spectrometry at clinical microorganism-identification laboratories.

“Although mass spectrometry technology has been a powerful scientific tool since the 1980s, it is only within that the last five years that it has been effectively used for the identification of microbiological organisms,” St. Pierre said in a statement. “The FDA has confidence in this technology and recognizes the need to rapidly address outbreaks both for C. auris and for other pathogenic microorganisms.”

The FDA proposed the regulatory rethink alongside news of the authorization of the use of a C. auris test under the premarket review pathway. Bruker Daltonik got the FDA nod to add C. auris to the hundreds of species covered by its Bruker Maldi Biotyper CA system after the device identified the yeast 100% of the time in a 28-sample study.

Bruker’s device identifies microorganisms by ionizing them with a laser to generate a spectrum. This spectrum is compared to a reference organism database to enable its identification. 

The FDA sees the availability of a device that can quickly identify C. auris and other microorganisms aiding efforts to manage outbreaks. In the case of C. auris, these outbreaks can have severe consequences. The former acting head of the CDC called the yeast a “catastrophic threat” last year. Hospital wards in the United Kingdom and elsewhere have struggled to control outbreaks of the yeast, leading to multiyear problems.

Suggested Articles

Zimmer Biomet has signed a deal to buy A&E Medical, maker of open chest surgery tools, for $250 million in cash.

Roche has received authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies.

Bayer strengthened its ties with Scottish AI developer Blackford Analysis to build a one-stop shop for applications in medical imaging.