Gen-Probe's DNA Play
Gen-Probe is one of the few successful players in the emerging field of DNA probes. Long a niche player, it is teaming up with bioMerieux and Chiron to tackle bigger, more complex markets in blood banking and viral and cancer diagnostics. To do this, it needs to acquire a new set of skills.
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The FDA's approval of Procleix HIV-1/ HCV combination assays all but cemented Chiron and Gen-Probe's dominance of DNA-based screening of the US blood supply. The approval changes the economics of providing HIV/ HCV screening to blood banks. The blood banks had been using Procleix or two separate tests supplied by Roche under IND status, paying at cost. Now, they have to pay commercial prices for Procleix. The hike is stretching budgets, but, for a variety of reasons, still more than 70% of US blood banks use Procleix, which is a combination of two assays on one sample.
The year-old union of bioMerieux-Pierre Fabre appears to be on the verge of disintegrating, amid lack of a coherent strategy, disagreements between the two founders who spearheaded the deal, and departure of key top executives. The company won't comment except to say that it is considering various alternatives including a break-up. Unraveling should not be difficult, since the two companies haven't integrated much. And the separation would leave bioMerieux, now the world's eighth largest diagnostics company, and Pierre Fabre, one of France's largest independent pharmaceutical companies, free to seek more appropriate solutions to the challenges they face.
The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."