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.

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.

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

“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

The FDA has approved its first contact lens designed to effectively slow the progression of nearsightedness in children, starting in ages 8 to 12.

Novartis tapped Biofourmis to develop tracking programs for heart failure patients, as the latter acquired Biovotion, makers of clinical wearables.

Janssen is planning its first completely virtual clinical trial, using personal smartphones and wearable devices with no in-person site visits.