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Pathway's Class I Determination for Collection Kit May Conflict with FDA Regulations

By Turna Ray

NEW YORK (GenomeWeb News) — Although Pathway Genomics announced earlier this week that the US Food and Drug Administration had "classified and registered" its saliva-collection kit as a Class I device, it appears that the company and the agency are not on the same page regarding that designation.

A Class I determination exempts the company from having to meet more stringent requirements under 510(k) classification requirements, but other companies selling similar products, such as DNA Genotek, have filed for 510(k) clearance of their saliva-collection kits.

"It is our understanding, from discussions with the FDA, that if our saliva-collection kits are to be used for collection of DNA for diagnostic testing, the collection kit must be 510(k) cleared," DNA Genotek spokesperson Shauna White told GenomeWeb Daily News sister publication PGx Reporter.

"It is also our understanding that to be compliant in the eyes of the FDA, laboratories conducting diagnostic testing are to be using 510(k)-cleared collection devices," White said.

She added that "Class I is a self-determined or self-declared process to the FDA but does not imply FDA clearance or registration."

The FDA appears to agree with that statement. "Registration is not a classification process," an FDA spokesperson told PGx Reporter. "We have told other manufacturers that this type of device" — a saliva collection kit — "would likely be a Class II device."

Class II devices generally require 510(k) clearance under FDA regulations.

Pathway Genomics did not return interview requests ahead of press time.

Pathway ran afoul of FDA regulations last year when the agency informed the firm that its genetic testing kit was a medical device that required marketing clearance.

At the time, Pathway was marketing its genomic analysis services directly to consumers without the involvement of a doctor. The agency warned Pathway after the company announced it would begin selling saliva kits for its service at Walgreens and CVS stores.

Over the last year, however, Pathway has abandoned the direct-to-consumer genomics model. According to information on its website, it now markets its services to physicians.


A more in-depth version of this article is available on Pharmacogenomics Reporter.

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