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.