Thyro Tec, Inc. (Honey Brook, Pa.) has received FDA approval for its new rapid hypothyroid diagnostic screening device, Thyro Test, which detects hypothyroidism within 10 minutes, right in the practitioner's office.
Thyro Test is the first and only product to receive FDA approval and a Clinical Laboratory Improvement Amendments waiver for identifying above-normal levels of thyroid stimulating hormone in a rapid format using a whole blood sample.
Thyro Tec is partnering with American Health Partners (Oklahoma City, Okla.) to market the test.