SAN DIEGO--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has classified and registered Pathway Genomics’ proprietary saliva collection kit as a Class I exempt device. With guidance from licensed health care providers, Pathway’s saliva collection kit is used to collect samples from patients for genetic testing purposes.
“FDA classification and registration is an important step for Pathway to provide physicians and patients with a safe and effective method of providing samples,” said Jim Nickel, M.D., Pathway’s medical laboratory director.
According to FDA regulation, Class I exempt devices must be manufactured under a specific quality assurance program.
“We’re committed to providing patients with medically actionable genetic information,” said Jim Plante, Pathway’s founder and CEO. “We’re also dedicated to doing it in a manner that adheres to regulations set forth by governing agencies.”
In addition to FDA classification and registration of Pathway’s saliva collection kit as a Class I exempt device, Pathway’s laboratory was recently accredited by the College of American Pathologists (CAP), and also received a Certificate of Accreditation under the Clinical Laboratory Amendments (CLIA) of 1988.
About Pathway Genomics
Located in San Diego, California, Pathway Genomics owns and operates an on-site genetic testing laboratory that is accredited by the College of American Pathologists (CAP), accredited in accordance with the U.S. Health and Human Services’ Clinical Laboratory Improvement Amendments (CLIA) of 1988, and licensed by the state of California. Using customized and scientifically validated genetic testing technologies within a controlled and secure environment, Pathway Genomics conducts comprehensive genotyping and targeted sequencing to generate personalized genetic reports. These reports address a variety of genetic issues, including an individual’s carrier status for recessive genetic conditions, food metabolism and exercise response, prescription drug response, and propensity to develop certain diseases, such as heart disease, type 2 diabetes, and cancer. Pathway’s diagnostic testing services are available to patients through their physicians and select health management programs. For more information about Pathway Genomics, visit www.pathway.com.