What is ThyroTest? ThyroTest is the first, and only, product to receive FDA approval for measuring above normal levels of thyroid stimulating hormone (TSH) in a rapid format This simple rapid diagnostic test is a qualitative measurement that allows physicians to review result for hypothyroidism in 10- Minutes with a whole blood sample

ThyroTest has received CLIA Waived status approval from the FDA which will further enhance the viability of the product in the US marketplace ThyroTest was originally approved as a moderately complex device by the FDA

Thyroid gland The thyroid is a butterfly-shaped gland that lies in front of the windpipe (trachea), just below the voice box (larynx). The thyroid gland uses iodine from food to make two thyroid hormones: thyroxine (T4) and triiodothyronine (T3). The thyroid gland stores these thyroid hormones and releases them as they are needed

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

Thyroid Stimulating Hormone (TSH), or thyrotropin, is the primary regulator of the functional state of the thyroid gland ThyroTest indicates Hypothyroid: > 5 IU TSH/mL

The TSH market It is estimated that 3 to 5% of the population has some form of hypothyroidism About 1 out of every 8 American women will develop a thyroid disorder. Often this condition goes undetected as the symptoms are often vague and nonspecific

Over 40 Million TSH tests are performed by laboratories on an annual basis. TSH tests are the fifth most widely performed test in all labs It is estimated that 13 million Americans are undiagnosed and needlessly suffer from the treatable hypothyroidism disease 20% of all infants born in America have hypothyroidism

More Americans suffer from thyroid disease than diabetes and cancer combined Estimated that 10% of all chronic depression cases are associated with undiagnosed hypothyroidism 50% of thyroid disease patients’ offspring will inherit the thyroid disease gene

Market Demographics More than 80% of Americans with thyroid disease are women Women are 5 times more likely than men to suffer from hypothyroidism Nearly 1 in every 50 women in America is diagnosed with hypothyroidism during pregnancy

6 of every 100 miscarriages is attributed to thyroid deficiencies during pregnancy As many as 18% of women are diagnosed with postpartum thyroiditis & approximately 25% of women will develop permanent hypothyroidism At age 60, 17% of women and 9% of men will have hypothyroidism

Common Symptoms Fatigue, Weakness, Weight gain, Mood swings, Dry & coarse skin and hair, Hair loss, Depression, Decreased libido, Trouble swallowing, Increased cholesterol, Heavy or irregular periods or trouble getting pregnant

Product Information 2 Easy steps 1.Add the contents (2 drops) of whole blood directly into sample well ("S" on the Test Cassette) 2. Add six (6) drops of Test Buffer into the sample well (labeled "S" on the Test Cassette) OR Pipette 200 mL of test Buffer into the sample well ("S" on the Test Cassette).

Product Storage The test kit may be stored at room temperature (15 – 30°C; 60 – 86°F); do not freeze. 18-month shelf life

Product Accuracy Overall Accuracy value = 95.5% Sensitivity 81.25% (26/32) with 95% CI: (63.6% %) Specificity 97.28% (250/257) with 95% CI: (94.5% %)

Package Components 20 - Test Cassette – Lateral Flow cassette individually wrapped in foil pouch, containing one (1) plastic pipette for blood sample. 1 -Dropper Bottle – 6 mL – containing buffer Diluent 20 - Spring loaded lancets 1 - Positive Control – Positive TSH serum for quality control testing of the system (See Quality Control Section). 1- Negative Control – Negative TSH serum for quality control testing of the system (see Quality Control Section)

Distribution and Sales Pricing: MSRP $14 per test / $280 per kit Distributor Margin: 25 % + CPT Code: (84443 QW) Reimbursement: $23 - $40

Point of Call General Practice, Family Practice, OB/GYN, Internal Medicine, Psychiatrist – all in this category that have a CLIA Laboratory in their practice Competition NO other rapid Lab based TSH testing In office mini units

Contact Information: Jim Small, CEO ThyroTec, Inc Horseshoe Pike, Suite 1 Honey Brook, PA Phone: FAX: