Originally published Sept. 29.
By Turna Ray
Genetic testing company Pathway Genomics announced this week that the US Food and Drug Administration has "classified and registered" its saliva collection kit as a Class I device, exempting the company from having to meet more stringent requirements under 510(k) classification requirements.
However, Pathway and the FDA may not be on the same page as to how the company's spit kits came to be deemed Class I devices.
Last year, the FDA asked Pathway to explain why its saliva collection kit had not yet been cleared or approved by the agency, but was intended to be used as a medical device. At the time, Pathway was marketing its genomic analysis services directly to consumers on the web, without the involvement of a doctor. The agency contacted Pathway after the company announced it would begin selling spit kits for its service at Walgreens and at CVS stores (PGx Reporter 5/19/2010).
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.
Still, Pathway may be running afoul of FDA regulations once again. "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." However, the spokesperson would not say whether the agency had discussed the 510(k) status of the saliva collection kit with Pathway, adding, "I can't comment on our discussions with a specific company at this time."
Indeed, other companies developing spit kits, where the saliva sample collected will be used for diagnostics purposes, believe they need 510(k) clearance for such devices. For example, in March, DNA Genotek announced that it had filed for 510(k) clearance of its Oragene Dx family of products, which includes products for collecting DNA samples from saliva.
"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 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."
She added that "Class I is a self-determined or self-declared process to the FDA but does not imply FDA clearance or registration."
If Pathway has self-registered its own saliva collection kit a Class I device, according to FDA regulations, the company may have inaccurately deemed that it does not need 510(k) clearance.
According to federal regulations, "RNA Preanalytical Systems," a designation that includes spit kits, are Class II devices. RNA prenanlytical systems are described as devices "intended to collect, store, and transport patient specimens, and stabilize intracellular RNA from the specimens, for subsequent isolation and purification of the intracellular RNA for RT-PCR used in in vitro molecular diagnostic testing." Class II devices generally require 510(k) clearance.
Pathway Genomics did not return interview requests ahead of press time.
In a statement announcing that its saliva collection kit is a Class I device, the company noted that "with guidance from licensed health care providers, Pathway's saliva collection kit is used to collect samples from patients for genetic testing purposes," and that "FDA classification and registration is an important step for Pathway to provide physicians and patients with a safe and effective method of providing samples."
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