Pathway Genomics' proprietary saliva collection kit has been classified and registered as a Class I exempt device by the US Food and Drug Administration (FDA).
Pathway’s saliva collection kit is used to collect samples from patients for genetic testing purposes.
Pathway medical laboratory director Jim Nickel said FDA classification and registration is an important step for Pathway to provide physicians and patients with a safe and effective method of providing samples.
Pathway founder and CEO Jim Plante said they are committed to provide patients with medically actionable genetic information.
"We’re also dedicated to doing it in a manner that adheres to regulations set forth by governing agencies," Plante said.