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The use of biomarkers to enhance drug development and clinical care is a long-standing trend in the healthcare industry. It's a trend that Dublin-based Biotrin, one of the stalwarts of Ireland's indigenous biosciences sector, has been tracking since its formation in the early 1990s. The company is now spinning out a new offshoot to take this side of the business forward, while it maintains its focus on virology diagnostics.

Biotrin's initial business model was based around the development of proprietary markers of organ damage, as a kind of early warning system for transplant rejection. "The original focus was on organ transplant and on xenotransplants," recalls CEO and founder Cormac Kilty. "That market didn't really develop for us."

Instead, the company built up a profitable virology diagnostics business, focused on emerging pathogens such as parvovirus B19 (the so-called fifth disease of childhood, which can cause miscarriage in pregnant women), and human metapneumovirus (first identified in the Netherlands in 2001 as a cause of respiratory disease in children). That business, which will remain under the Biotrin banner, is currently producing around €10 million ($15.8 million US) annually.

Courtesy merrion pharmaceuticals

Looking to the future, the company sees potential for additional growth from its role in one of the industry's biggest vaccine introductions. Biotrin has licensed intellectual property from the US National Cancer Institute that will underpin a series of immunoassays for monitoring the incidence of human papillomavirus (HPV)16 and HPV18 infection and ensuring that the cervical cancer vaccines designed to protect against them - Merck's Gardasil and GlaxoSmithKline's Cervarix - are inducing the desired neutralizing antibody response. "They're going to be ready for trials later this year. We think that could be very big," says Kilty.

Meanwhile, the organ biomarker business, which will be the focus of the new venture, has diverged substantially from the company's original focus on transplantation. Biotrin has built up a portfolio of biomarkers for detecting acute kidney injury, including the alpha and pi isoforms of glutathione S-transferase and, in rats, renal papillary antigens 1 and 2. Its rat biomarkers are currently being validated by the biggest names in the pharmaceutical industry, under the FDA's Critical Path Initiative for modernizing drug development. Their obvious application is in preclinical toxicity testing.

The human biomarkers are currently being used in drug trials. Their major commercial promise, however, resides in their potential to drive decision-making in clinical settings by providing physicians with actionable information. The company has seven clinical trials underway, across a range of patient groups at risk of developing renal injury following treatment.

Biotrin is one of the survivors of Irish biotech, having endured several bubbles and industry downturns during its 15 years in business. It was one of the few Irish biotechnology firms to have attracted international venture capital during the 1990s. Kilty and his management team took the company private in 2003, in a management buyout (MBO) backed by a Berlin-based investor Dr. Schmidt Biotech AG (which Kilty subsequently bought out in a secondary transaction).

The company is now seeking external investment to fund the spinout, which has an existing turnover of around €1.5 million ($2.3 million US). "We've invested heavily in it ourselves since the MBO," says Kilty. "Now it needs to get a bigger injection of cash to bring some of the discovery work to the market."