"Trinity's scientists are expert in the development of immunoassays..."

Simultaneously, governments, commercial organisations and individuals are attempting to minimise the growth of the cost of healthcare. Despite efforts that go back decades, healthcare consumes over 15% of the US gross domestic product and continues to grow at a rate that at least equals, and most often exceeds, the general rate of inflation.

The lifespan of people has increased more in this century than in all previous history. Today's challenge is to prolong healthspan, the portion of lifespan when an individual is in good health, and this expands the potential for products and services. As the elderly population develops more chronic diseases, the cost of care for these debilitating diseases adds significantly to overall healthcare expenditure.

Moreover, the basic principles of medicine will not change and the in vitro diagnostics industry will benefit. Patients with disease symptoms must be diagnosed and they must be treated and that treatment must be monitored. New tests can have a very positive impact and also modern attempts to reduce costs will result in increased test volume.

Managed care creates a greater emphasis on preventative medicine and early diagnosis is a key component of effective preventative medicine. This increases the test volume (upfront) as well as the number of man years of life during which testing will occur i.e. but for preventative medicine people would die sooner and thus be treated less.

Preventative testing will occur more on the "frontline" placing emphasis on point-of-care (POC) testing whether in the physician's office, clinics or at the site of medical delivery.

The in vitro diagnostics business is estimated to be valued at US$21bn worldwide and growing at 8% per annum. The industry can be viewed in several ways, the most common of which is by laboratory discipline. The discipline in which Trinity Biotech operates is the immunoassay area. The market for immunoassays was valued at US$5bn in 1996 and is predicted to grow at a compounded growth rate of 12% per annum through 1998 to the year 2006.

Trinity's scientists are expert in the development of immunoassays and their expertise is utilised to develop both microtitre plate based immunoassays and rapid one-step devices. The microtitre plate based immunoassays are used in the high volume centralised laboratory environment. The unitised one-step immunoassays which are on Trinity's unique Uni-Gold^TM format, are used in the POC and the self-test (OTC) markets.

Product Portfolio 

"Today the Company has an impressive portfolio of more than 90 products which are sold in over 65 countries..."

When Trinity entered 1996 the company had three products, SeroCard™ HIV, SalivaCard™ HIV and Uni-Gold™ hCG.

Today, the company has an impressive portfolio of more than 90 products which are sold in over 65 countries throughout the world. This product portfolio has resulted from in-house development of products, the acquisition of Clark Laboratories in Jamestown, New York and the acquisition of the infectious disease business of Centocor Inc. based in the United Kingdom.

Uni-Gold™ Product Range

During the past year, Trinity focused on gaining regulatory approval and penetrating world markets with its unique one-step Uni-Gold™ HIV product. The Company signed a pan-African distribution agreement with SmithKline Beecham International and have already commenced shipments to South Africa.

Trinity was also pleased to announce that the Uni-Gold™ HIV product was selected by the Malaysian Government as the product of choice for their HIV screening program. This relationship will extend through 1998 and beyond. In addition, during 1997 Uni-Gold™ HIV gained regulatory approvals and was launched in a number of other markets including Guatemala, Peru, Egypt and Turkey.

Trinity's Uni-Gold™ Hepatitis B surface antigen test is a unique one-step test utilising serum or plasma for the detection of the surface antigen responsible for Hepatitis B. It has a sensitivity to 2 ng/ml and has gained approval and commenced sales in a number of countries including South Africa, Egypt, Guatemala and Peru.

During the past year, Trinity's scientists completed the development of Trinity's Uni-Gold™ H. pylori test. Helicobacter pylori is a bacterium that infects and inflames the stomach lining and causes approximately 90% of peptic ulcers.

It is believed to be a primary carcinogen leading to the development of stomach cancer. The current worldwide market is estimated to be US$100m growing at 30% per annum and Trinity's one-step Uni-Gold^TM H. pylori test has commenced sales in Europe and will shortly be filed with the FDA in the United States.

Trinity's Uni-Gold™ Strep A test is nearing completion and is expected to be filed with the FDA during the third quarter of 1998. Sales have commenced in international markets and a US distribution partner has been identified.

Trinity is utilising its expertise to further expand its product portfolio of one-step tests. Other tests currently being developed by Trinity include a one-step Chlamydia test and a prostate specific antigen (PSA) test.

Microtitre Plate EIA Product Range

Trinity is rapidly building a leadership position in the segment of the immunoassay market which utilises microtitre plates to perform enzyme-immunoassays. Trinity's scientists in Dublin have developed an exciting range of products which identify enteric diseases. This range includes tests for Rotavirus, Adenovirus, Clostridium difficile, Giardia lamblia, Cryptosporidium and E. histolytica.

The Adenovirus and Rotavirus tests received FDA approval during 1997 and the Rotavirus received approval from the Paul-Ehrlich-lnstitut (PEI) in Germany. Approvals for the remainder of the tests from both regulatory authorities are expected during 1998. Trinity plans to further expand its range of enteric products through research and development conducted in its Irish facility.

The acquisition of Clark Laboratories in Jamestown, New York provided Trinity with a broad product portfolio in the area of microtitre EIA products. Clark's product line includes tests for Toxoplasmosis, Cytomegalovirus, Rubella, Herpes Simplex and a range of autoimmune disorders.

In July of 1997 through the acquisition of the infectious disease business of Centocor in the United Kingdom, Trinity further expanded its microtitre range. The tests acquired included the leading microtitre plate test for Syphilis IgG and IgM which is the only EIA Syphilis product approved for blood bank testing in the United States.

Other products acquired through the Centocor acquisition included a test for Chagas which is the disease caused by the parasite Trypanosoma cruzi. This disease is extremely prevalent in Latin American countries and also in the Southern states of the USA.

Cancer Markers

An exciting development during 1997 was the licensing by Trinity from Centocor of five cancer markers. These markers are PSA, CA15.3, CA19.9, CA25.3 and CA72.2 which monitor the progress of prostate, breast, gastric and ovarian cancers.

Trinity has already commenced the adaptation of these tests to its own microtitre plate format and is expected to have this project completed in 1999.

Manufacturing Facilities

At the end of 1997 Trinity purchased a new manufacturing site in Dublin, Ireland. This 42,000 sq ft facility is currently being upgraded and is expected to be occupied in May of 1998. As a result Trinity, will have two manufacturing sites; one in Ireland and one in Jamestown, New York giving a combined manufacturing capacity of 66,000 sq ft. This will provide sufficient manufacturing capacity for Trinity's projected growth rate for the foreseeable future.

Marketing

As a result of its own marketing efforts and through the acquisition of Clark Laboratories and Centocor's infectious disease business, Trinity now has a worldwide distribution network of more than 100 distributors operating in 65 countries. Trinity has continued to build on its extremely successful relationships with Warner-Lambert for pregnancy in the OTC market in the United States, with the Wampole division of Carter Wallace for the clinical laboratory segment in the United States and with SmithKline Beecham for rapid HIV testing throughout Africa.

In addition, Trinity has established marketing relationships with some of the key players in the diagnostics industry, including Sanofi Diagnostics Pasteur and Gull Laboratories.

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