Marketing Immunoassays for In Vitro Diagnostic Manufacturer
An in vitro diagnostic company developed a superior antibody against IGF-I (insulin-like growth factor-I) suitable for immunoassay formats. IGF-I is the poly-peptide hormone secreted in response to growth hormone and is the metabolic mediator of effects attributed to growth hormone. The company wanted to market immunoassays, made with their patented antibody.
Academic research available through scientific publications suggested IGF-I could be a diagnostic marker for growth hormone deficiency, and may be useful for monitoring therapeutic response in patients receiving growth hormone. There were, therefore, potential markets in pharmaceutical industry and clinical diagnostics.
User friendly immunoassays were developed with the antibody and FDA (510k) approval was obtained. Assays were designed and modified for acceptable performance even with novice lab experience. This consultant added extra quality control criteria to insure lot-to-lot consistency. Some clinical sites were selected to run assays on relevant patients in order to provide technical data for FDA submission and for marketing purposes.
The most obvious market was in clinical labs for diagnosis of growth hormone deficiency. Previously, diagnosis was based on growth hormone stimulation tests, which perform poorly. Lots of patients were being misdiagnosed as normal, and thus deprived of growth hormone therapy. This consultant collaborated with clinical consultants who provided data comparing the stimulation test to the IGF-I assay - and showed IGF-I superiority. But, this condition is rare and the size of the testing market is limited.
Several pharmaceutical companies were adding growth hormone to their pipeline. A variety of new delivery methods and sustained release preps were being evaluated - IGF-I has to be injected. A market in clinical trials was identified. Pharmaceutical companies demanded a large normal range based on sex and age. In order to compete with other commercially available IGF-I tests, this consultant provided an expanded normal range with thousands of IGF-I values. This required accumulating specimens for in-house testing, to be added to values already provided by our clinical consultants. Another marketing advantage was provided by validating the IGF-I assay for easier specimen collection and handling. We applied the assay to dried blood spot technology, so that a patient could collect his or her own sample (like doing blood glucose at home) and mailing the specimen to the lab for analysis. A significant cost savings was achieved for pharmaceutical companies doing clinical trials. Contracts with several pharmaceutical companies for using the immunoassay in their drug clinical trials were achieved.
Cancer researchers expressed interest in IGF-I as a risk for cancer. IGF-I was known to promote tumor growth in vitro cell cultures. Lab support was provided to academic and governmental cancer investigators for the purpose of making IGF-I determinations in stored samples from large epidemiological studies. Researchers were not willing to use irreplaceable specimens without guarantee of assay performance. Since these specimens are archived under frozen storage, studies were conducted by the manufacturer on stability of IGF-I in stored specimens. Inter- and intra-assay variability was demonstrated to provide statistical power necessary for meaningful results. The dried blood spot validation permitted studies in remote populations, like Russia.
There was a lack of lab experience among epidemiologist investigators. They did not possess the expertise to run the IGF-I assay. So, this consultant established a CLIA/FDA certified lab to provide testing for hire. This facilitated marketing the immunoassays as originally desired, and lab services were also marketed for a profit. This immunoassay became the "gold standard" for IGF-I assays in cancer research. Many scientific publications resulted.
The immunoassays for IGF-I were successfully marketed by providing scientific approaches and solutions. Potential markets were identified and advantages were created through scientific validations for each market. The immunoassays were well published in the scientific literature providing market advantage and prestige for the company.
To see the resume of the expert associated with this case study, see the link below.
