FDA proposes shake up for core oncology companion diagnostic classification
The US FDA (MD, USA) last week proposed a reclassification of companion diagnostic assays that could speed up the pipeline to approval for these devices.
On November 25, the organization announced in the Federal Register that it would down-classify certain Class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product to Class II, subject to premarket notification.
As per the US’s three-tier, risk-based medical device classification system, Class III devices are considered high risk and are subject to premarket approval, whereas Class II (moderate to high risk) can be submitted for market authorization via the 510(k) route.
This means that, should the proposal come into effect, core companion diagnostics will be shifted onto a different pathway, while still subject to stringent regulation via special controls, including issuance of performance standards, postmarket surveillance, patient registries, and development and dissemination of guidelines and recommendations.
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It creates a new device classification regulation deemed “Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product”. This characterizes oncology therapeutic nucleic acid-based test systems as prescription in vitro diagnostic devices intended to detect specific genetic variants and/or other nucleic acid biomarkers in human clinical specimens using nucleic acid amplification technology and/or sequencing technology that are indicated for use with a corresponding approved oncology therapeutic product.
The regulations would apply to currently approved devices as well as future devices that fit into this category.
According to the FDA, the decision was made based on “extensive” premarket approval data, peer-reviewed research on these established technologies and data “demonstrating a lack of significant postmarket safety signals with oncology therapeutic nucleic acid-based test systems.”
The change, the agency explains, should help to bypass regulatory hurdles and provide a faster and cheaper route to FDA approval for a major class of molecular diagnostics.
“A 510(k) typically results in a shorter premarket review timeline compared to a [premarket approval], which ultimately may provide more timely access of these types of devices to patients,” the FDA wrote. “FDA expects that the reclassification of these devices would enable more manufacturers to develop these types of devices such that patients would benefit from increased access to appropriately safe and effective tests.”
There will now be a 60 day public comment period, open until January 26, 2026. If finalized, the final order would take effect 30 days after it is published in the Federal Register.
