The company develops, manufactures and markets high quality diagnostic kits and systems for the detection of infectious diseases, genetic screening and other clinical conditions for over 30 years to a network of distributors worldwide.
The tests are based upon various immunological and molecular techniques. The company is also the manufacturer of a novel test (ELISA test) developed to determine the Haptoglobin type in human serum.
The Haptoglobin (Hp) ELISA is intended for use in diabetic patients only, for the qualitative determination of Hp phenotypes (Hp 1-1, Hp 2-1, or Hp 2-2) in human serum. The test also assesses the beneficial effect of Vitamin E. The test should be used in conjunction with clinical evaluation and patient assessment as an aid in predicting risk of coronary arterial and cardiovascular disease.
The company desires for greater sales of their ELISA test for Haptoglobin, through direct collaboration with laboratories, or distributors to expand their sales. The company is seeking a commercial agency agreement or a distribution services agreement to reach a wider market.
Advantages & innovations
The company is the only manufacturer of the patented Haptoglobin typing test which was developed to provide a solution for the rising public health burden caused by cardiovascular and renal complications of Diabetes Mellitus (DM). The estimated burden is over $100 billion per year in the USA alone and the problem is increasing. Medications to treat these complications are extremely expensive and require lifetime use. The purpose of this diagnostic test is to provide a once in a lifetime test that will indicate whether a particular DM individual is at high risk for these diabetic complications and may benefit from Vitamin E supplementation. The clinical relevancy is supported by eleven longitudinal studies in diverse ethnic groups which demonstrated that DM individuals (both Type I & Type II) with the Hp 2-2 genotype (35% of all DM individuals), have a 2-3 fold increased risk of developing cardiovascular disease and end-stage renal disease as compared to Hp 2-1 and Hp 1-1 DM individuals. On the basis of this information the risk of diabetic complications is assessed, and decided whether the patient may benefit from vitamin E supplementation to assist in preventing these complications. Clinical accuracy of the test was determined and validated in over 8000 individuals with Diabetes from seven different clinical studies.
Stage of development
Already on the market
Partner sought
The company is seeking to expand the sales of the Haptoglobin Typing ELISA by locating any potential distributors or through direct contact with any types of partners such as endocrinology or diabetes laboratories, in order for collaboration between the two. The company is open to collaborating with a distributor, with in depth knowledge of the industry, to expand the reach of its product. Additionally, the company is open to establishing a commercial agency agreement, to be represented in an international market.