Fact Sheet

About Thyretain®

Thyretain - TSI Reporter BioAssay is an in vitro diagnostic use test that specifically detects auto-antibodies called thyroid stimulating immunoglobulins (TSI) in patient serum.

Thyretain - TSI Reporter BioAssay is the only commercially available IVD that specifically detects TSI and is to be used as an aid in the differential diagnosis of Graves’ disease, an autoimmune thyroid disorder.

Thyretain - TSI Reporter BioAssay was tested under a two-phase multi-site, clinical trial of the product in nearly 600 patients.

Thyretain - TSI Reporter BioAssay will enable physicians to detect TSI in the bloodstream and assist them in confirming the diagnosis of Graves’ disease sooner than with standard thyroid test panels only.

Thyretain - TSI Reporter BioAssay is a rapid and reliable bioassay that provides a definitive assessment that could lead to earlier diagnosis of Graves’ disease and better patient management.

 

The Thyretain - TSI Reporter BioAssay kit includes a genetically-engineered cell line that produces the reporter enzyme luciferase in response to specific TSI binding and the amount of luciferase produced is then rapidly detected using a luminometer.  

If used earlier when hyperthyroidism is first suspected, Thyretain® may provide primary care physicians and patients alike reliable diagnostic information when classic symptoms of goiter or thyroid-related eye disease (ophthalmopathy) are absent.

Thyretain TSI Reporter BioAssay offers greater specificity as it only detects the TSI present in a patient’s serum, aiding in a more accurate early diagnosis of Graves' disease, and with further studies may be shown useful for evaluating the patient's response to therapy, and predicting remission from disease.

The Thyretain TSI Reporter BioAssay is available through major commercial reference laboratories in the U.S., and in select hospital systems.

About Diagnostic Hybrids

Diagnostic Hybrids, a Quidel Company, invents, develops, manufactures, and sells innovative diagnostic and analytical products for a wide range of viral respiratory diseases, herpes virus infections, and other specific viral and thyroid diseases.

Diagnostic Hybrids develops and commercializes innovative and genetically engineered cell-based detection products for the pharmaceutical and biotechnology industry, with an initial focus on pharmacology assays and products that measure drug clearance and anti-viral interventions with drugs and vaccines.

Diagnostic Hybrids is certified to ISO 13485 standards and manufactures live continuous and primary cell cultures for clinical diagnostics and pharmacology assays from its headquarters in Athens, Ohio.

Diagnostic Hybrids was named one of the “500 Fastest Growing Companies in America” in 2004 and 2005 by Inc. magazine.

Diagnostic Hybrids is a pillar member of BioOhio, a statewide organization of bioscience companies accelerating the bioscience and healthcare economy in Ohio.

For more information, please visit dhiusa.com.

About Graves’ disease

Graves’ disease is an autoimmune disorder that involves the thyroid gland. It is a specific disorder that involves misguided targeting of normal cells and structures in the thyroid gland.

Graves’ disease is characterized by the presence of thyroid stimulating immunoglobulins (TSI) in the bloodstream, which results in over-stimulation of the thyroid gland and low thyroid stimulating hormone (TSH) levels, a condition known as hyperthyroidism. They may also promote the development of disorders involving tissues that surround the eyeballs and the tissues directly beneath the surface of the skin.

By contrast, hypothyroidism is a condition characterized by the effects of too much thyroid hormone tissues of the body.

Some of the common symptoms associated with Graves’ disease are:

  • Increased heart rate/palpitations
  • Weight loss
  • Temperature sensitivity/heat intolerance
  • Nervousness
  • Restlessness
  • Insomnia
  • Fatigue/Weakness muscle strength
  • Trembling hands
  • Breathlessness
  • Staring gaze
  • Warm moist skin
  • Increased bowel movements

Graves’ disease is often called “toxic goiter” because the entire thyroid gland is significantly enlarged/affected.

Currently, Graves’ disease can be difficult to diagnose. Many physicians can detect Graves’ disease with the presence of thyrotoxicosis, a series of blood tests, thyroid scan and symptom diagnosis.

Treatment of Graves’ disease ranges on the progression of the disease. Mild cases can be treated with antithyroid drugs. More complicated cases can be treated with radioactive iodine or thyroid surgery.

There are an estimated more than four million individuals living with Graves’ disease in the United States. Up to 360,000 new cases are diagnosed every year.

Graves’ disease affects 1 to 2 percent of the population, and mostly appears in women in their 40s. It has the tendency to run in families.

Eighty percent of Graves’ disease cases occur in women, and can be difficult to diagnose because symptoms vary greatly and often mimic other illnesses.  

Graves’ disease was named after Robert Graves, an Irish physician who first identified the disorder in 1835.