Transcript Document

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 10Minutes 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% - 92.8%)
Specificity
97.28% (250/257) with 95% CI: (94.5% - 98.9%)
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 (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.
1801 Horseshoe Pike, Suite 1
Honey Brook, PA 19344
Phone: 610-942-8971
FAX: 610-942-8973
[email protected]