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FDA allows marketing for blood test to help diagnose type 1 diabetes
The FDA gave the go-ahead for marketing of the first zinc transporter 8 autoantibody test to help determine if a person has type 1 diabetes rather than gestational or type 2, according to a release from the agency.
The zinc transporter 8 autoantibody (ZnT8Ab) ELISA Assay, when used with other tests and clinical information, would allow for earlier treatment and diagnosis of the disease, according to the release.
Manufactured by the Idaho-based KRONUS Market Development Associates, Inc., ZnT8Ab works by detecting ZnT8Ab in the blood; it is produced by the immune system in patients with type 1 diabetes but not in type 2 or gestational, the release stated.
“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA, said in the release.
ZnT8Ab was reviewed through the FDA’s regulatory pathway for low- to moderate-risk medical devices with no equivalent already on the market, according to the release.
The agency reviewed data from 569 blood samples — 323 from patients diagnosed with type 1 diabetes and 246 from patients diagnosed with other kinds of diabetes, other autoimmune diseases and other clinical conditions, according to the release.
The assay detected the autoantibody in 65% of samples from patients with type 1; incorrect positive results were seen in less than 2% of samples from patients diagnosed with other kinds of diabetes or other diseases.
The FDA noted in the release that a negative test result does not rule out a type 1 diabetes diagnosis and should not be used to monitor disease stage or treatment response.