ThyroTest, a new rapid hypothyroid diagnostic screening device from ThyroTec (Honey Brook, Pennsylvania), has received a CLIA waiver that will allow for detection of a common thyroid disease, much sooner rather than later, for millions of Americans and most likely at a lower cost to the overall healthcare system.

Currently patients suffering from symptoms of hypothyroidism have to wait days to discover lab results, the company said. Although ThyroTest received FDA approval in July 2003, it most recently also gained CLIA waiver status, allowing patients to get test results for hypothyroidism in minutes, right in the physician's office.

The CLIA waiver will increase by "10-fold" the number of healthcare offices approved to administer the test, Jim Small, president and CEO of ThyroTec, told Diagnostics & Imaging Week.

"We are excited about bringing ThyroTest to the marketplace," Small said. "ThyroTest is the first, and only, product to receive FDA approval and CLIA waiver for identifying above-normal levels of thyroid stimulating hormone [TSH] in a rapid format. This simple, rapid diagnostic screen test is a qualitative measurement that allows physicians to screen patients for hypothyroidism in 10 minutes with a whole blood sample."

The stick test, which must be administered by a healthcare professional, is lateral flow technology and measures elevated TSH. A certain positive level is an indicator of hypothyroidism, Small said, noting that it would be "not a definitive diagnostic" but a "strong indicator" of hypothyroidism.

A healthcare worker uses two drops of whole blood and follows that with six drops of "buffer" that will flow past a point on the test that has antibodies that will react to sufficient levels of TSH to cause a stripe to appear, which would indicate a positive test.

"It's very similar to a pregnancy test," said Small. "And then it has a built-in control that, of course, tells whether the test went to completion."

More Americans suffer from thyroid disease than diabetes and cancer combined, the company said. There are likely about 13 million Americans who have hypothyroidism today who are not aware of it, according to the Colorado Prevalence Study of 1996, Small said.

Hypothyroidism develops when the thyroid gland does not produce enough thyroid hormone, which regulates the body's metabolism. A lack of thyroid hormone affects many body systems. The incidence of hypothyroidism tends to increase with age, with older people, especially women, at the highest risk.

Common symptoms include weight gain, fatigue, mood swings, weakness, dry and coarse skin and hair, hair loss, depression, decreased libido, trouble swallowing, increased cholesterol, heavy or irregular periods or trouble getting pregnant.

Roughly one in every eight American women will develop a thyroid disorder during her lifetime, the company said, and it is estimated that 3% to 5% of the U.S. population has some form of thyroid disease.

ThyroTec is a company that is built completely around the ThyroTest, in development for about six years, Small said. ThyroTec was formally formed in November 2001.

"We're actually trying to stay as virtual as possible," Small told D&IW. The company has four partners and a small administrative staff. All other requirements, such as shipping and assembly, are "subbed out to other providers," he said.

ThyroTec has chosen American Health Partners (Oklahoma City) to develop the ThyroTest brand identity, final market preparation, selection of national sales partners, training and the management of distribution.

"American Health Partners recognizes the benefit of providing doctors a rapid screen for hypothyroidism. Millions of patients who needlessly suffer from the symptoms of hypothyroidism can be screened in one office visit and further steps for treatment can begin immediately," said Brian Banks, company president. "[We] bring medical innovations to life through a proprietary market readiness process and proven distribution management network. We look forward to partnering with ThyroTec on this outstanding medical innovation."

ThyroTest is expected to be on the market by Feb. 1, and certainly no later than mid-February, Small said.

The test will be reimbursed under CPT code 84443QW, which indicates it is CLIA-waived, he said. Although he could not state definitively what the amount of the reimbursement will be for healthcare offices, "the normal 84443 reimbursement is around $23.56."

The cost for the current blood test for measuring TSH "varies hugely because of managed care and managed care contracts," according to Small. A private payer could pay as much as $75 to $85 for a traditional TSH test, whereas someone in a managed care plan would not see the difference in cost between the two different tests, because his or her co-pay would remain the same.

"Certain patients may not see it, but overall, it should lower the total cost of screening for hypothyroidism because last year there were 120 TSH tests performed in the U.S.," Small said. "Forty-five million of those were done for diagnostic purposes, meaning let's see if you have hypothyroidism,' and a good percentage of those that were done with a much more expensive test would probably be determined with the Thyrotest."

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