Alpha Diagnostic International, Inc. (ADI) is a privately held, U.S. biotechnology company headquartered in San Antonio, Texas.  ADI develops, manufactures, and supplies novel diagnostic and quality control reagents and test kits for use in basic biological and disease research in humans and animals.  An important mission of ADI is to develop and supply diagnostic and validating solutions for promoting global health through improved vaccine therapeutics and mitigating the spread of human and animal diseases.

History

ADI was founded in 1993 as a provider of custom antibodies and immunoassays for research applications.   The primary focus during the early years was the development of immunoassay reagents and kits that were not readily available to researchers.  As a result of the human genome project and the human proteome initiative, several new proteins were rapidly identified.  However, there were no readily available reagents for carrying out detailed studies on these newly identified proteins.  ADI was able to supply researchers worldwide with a number of novel reagents that enabled them to make rapid strides in proteomic research.  Over the years, the company expanded its focus and product development efforts to providing solutions for unmet needs in vaccine therapeutics, biologic drugs, infectious disease testing, and other novel products directed to the consumer market which includes meat adulteration testing and rapid tests for fertility monitoring in household pets and farm animals.

Scientific Staff & Personnel

As a company dedicated to providing innovative reagents, tools and solutions for research and diagnostic applications worldwide, ADI understands the critical and unmet needs of these communities.  An important goal of ADI is to understand exactly what scientific researchers and diagnostic testing communities need and to provide the most effective solution in an expeditious manner.  ADI is able to do this successfully because of the decades of knowledge, experience and expertise of the management and scientific staff.  ADI’s management and scientific staff comprise scientists, laboratory technicians, and bioinformatics specialists, with the core group of individuals having been a part of ADI since its very inception.  Over the past couple of decades, ADI has invested and continues to invest significant effort in developing and adding staff members who share the ADI philosophy of being a trusted provider of innovative reagents and solutions to the scientific community.

Programs

Human Vaccine Design and Testing

The global vaccine safety initiative being championed by WHO and organizations such as GAVI is progressing well towards its goal of providing basic immunization to children in many underdeveloped and developing nations.  The world vaccine market is projected to be about 50 billion dollars (USD) by 2020.  Yet, there are no companies engaged in developing appropriate vaccine tests to establish efficacy or improve current vaccines.  Vaccine identification tests and determining vaccine potency after transport or storage are generally not available.  Therefore, ADI has developed test kits that enable performing a rapid evaluation of the efficacies of most common vaccines.  Most vaccines are shipped or transported to locations without adequate refrigeration and storage facilities, thereby resulting in vaccines with reduced efficacies.  ADI has developed a number of ELISA kits for testing Ebola, MERS, HPV, Meningitis, Pneumococcus, DPT, MMR, Rotavirus, Hib, Hepatitis, Tuberculosis, Typhoid and Influenza vaccines.  By making these test kits available to the international community, ADI strives to actively promote and participate in global health initiatives.

Human Biologic Drugs Monitoring

The availability of a new class of drugs (biologics) against several diseases, such as cancer and autoimmune diseases, has been a boon to healthcare across the world.  These biologic drugs are very expensive.  Global therapeutic antibodies accounted for $80 billion (USD) in 2013.  The top 10 best-selling monoclonal antibody therapeutics (Humira, Remicade, Enbrel, Rituxan, Avastin, Herceptin, Lucents, Synagis, Prolia/Xgeva and Erbitux) accounted for $64 billion (USD) in sales in 2014.  These drugs can potentially lose their efficacy when stored under inappropriate conditions.  There are also instances of adulteration of these drugs, rendering them potentially unsafe and non-effective.  ADI has undertaken the challenge of developing test kits that enable the identification of  the authenticity and efficacy of these expensive drugs.

Veterinary Disease and Vaccines

Veterinary vaccines help to improve animal health, increase production of livestock in a cost effective manner, and prevent transmission of diseases among animals.  Of the major geographical market segments comprising North America, Europe, and Asia-Pacific, the European market accounts for >70% of the global veterinary vaccine market revenues.  The global market for veterinary vaccines was estimated to be worth $12.0 billion (USD) in 2014.  Expected to grow at a CAGR of 8.8%, the market is set to reach a value of $19 billion (USD) by 2019.  However, there are very few companies serving the animal diagnostic demands and virtually no commercial entities offering tests for animal vaccines.  ADI has developed specific ELISA and other tests based on the type of disease found in companion and farm animals – poultry vaccines (Bronchitis, Avian Influenza, Marek’s disease, New castle disease), and swine vaccines (Porcine reproductive disease, Swine influenza, Swine Pneumonia).  Most of the animal tests are being marketed overseas pending USDA approval for sales in the US. 

Laboratory Animals Disease and Diagnostics

Laboratory animals (mouse, rat, rabbit, goat, pig, hamster, etc.) play a pivotal role in pre-clinical testing of various drugs.  Therefore, reputed animal suppliers routinely test for 40-50 different bacterial and viral diseases to make sure that animals used in research are of good health.  ADI has generated more than 20 ELISA kits designed for testing laboratory animals for the presence of bacterial and viral infections.  Many of these test kits are exclusively available from ADI.

Human & Animal Autoimmune Diseases Tests

According to the NIH, autoimmune diseases are ranked amongst the top ten causes of death in the U.S.  The autoimmune disease (Systemic, Localized, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ankylosing Spondylitis, etc.) diagnostics market is rapidly growing and accounts for about $15 billion (USD) in revenue.  Since its inception in 1993, ADI has continued to develop ELISA tests for both human and animals.  In fact, ADI is the sole source supplier of many autoimmune ELISA test kits for animals (mouse, rat, monkey, etc.).

Bioinformatics & Proteomics

Human Genome Project (HGP) is an international scientific research project with the goal of identifying and mapping all of the genes of the human genome from both a physical and functional standpoint.  It remains the world’s largest collaborative biological project.  Although HGP was formally started in 1984 and completed in 2003, the cloning and sequencing of genes was being reported at a frantic pace since the 1970s.  There remains a huge demand to study various genes or proteins by making antibodies from the available gene sequences.  ADI mastered various bioinformatics tools and started offering these ‘custom gene synthesis, protein or peptide synthesis and antibody services’ in 1993.  Over the past 20 years, ADI has made tens of thousands of antibodies for researchers all over the world that have resulted in >5,000 citations in peer reviewed journals.  ADI continues to offer the same level of these custom services and help to advance our scientific knowledge.

Unique Technologies:

RecombiVirus ELISA Kits:  RecombiVirus series of ELISA kits are based upon purified, recombinant viral and bacterial antigens.  Such kits are available for research for Ebola, MERS, HPV, Meningitis B, etc.

VacciGel^TM ELISA Kits:  VacciGel series ELISA kits are an innovative and industry’s first test for the direct identification and measurement of vaccine components adsorbed on Alum adjuvants.  The VacciGel series of kits are available for Hepatitis B, Diphtheria, Tetanus, Pertussis, Rabies, and HCG (anti-fertility) vaccines.

TruStrip^TM Sample Transfer System:  TruStrip sample transfer system is a novel product that allows for quantitative loading and elution of small volume liquid samples on adsorbent pads.

TruStrip^TM Western Blot Validation and Quantification System:  TruStrip western blot validation and quantification system allows researchers to trouble shoot western blot experiments and perform accurate quantification of proteins of interest.

Focus Areas

Improved vaccines (human and animals)

Humanized antibodies and Therapeutics

Rapid tests for research and veterinary diagnostic

Consumer food product testing

Novel sample transfer and validation systems

Primary antibodies for basic reasearch