By Lisa Seachrist

Washington Editor

Sample collection giant Becton, Dickinson and Co. and nucleic acids purification specialist Qiagen N.V. formed a joint venture aimed at creating the standard for sample collection and preparation for molecular diagnostic testing.

The venture, named PreAnalytiX, which will be based initially at a Qiagen facility in Switzerland, intends to create a standard, automated system that will integrate sample collection, purification and isolation of notoriously labile nucleic acids for molecular diagnostic testing. The two companies hope the products that result from the venture will revolutionize the current molecular diagnostics industry and prove vital to the burgeoning fields of pharmacogenetics and pharmacogenomics.

"This is the most significant deal we've done at Qiagen," said Peer Schatz, CFO for Qiagen, of Venlo, the Netherlands. "It's really a natural fit for the two companies."

Franklin Lakes, N.J.-based Becton, Dickinson (BD) is the market leader in blood sample collections, producing nearly 90 percent of all evacuated sample tubes used in blood collection. Qiagen has developed platform technologies for the isolation of nucleic acids - RNA and DNA - from biological samples. PreAnalytiX intends to combine the technologies to create a seamless system for the preanalytical tasks of collecting, stabilizing and readying nucleic acids for molecular analysis.

While having been touted as the new wave in diagnostics, molecular diagnostics has been particularly slow to take hold in the clinic. No small part of the problem is that sample preparation tends to be labor intensive, requires the use of some toxic chemicals and, oftentimes, produces unpredictable results. An integrated, automated system for collecting and isolating nucleic acids may put the field of molecular diagnostics on a more firm footing.

"People have thought molecular technology would just take off," said Caroline Popper, vice president and general manager of BDGene, an internal venture in BD focused on molecular technologies. "The biggest reason it hasn't is problems on the preanalytical side - it is very important that you get nucleic acids in optimal condition. We are trying to create the standard to do that."

The two companies have contributed nearly $1 million each to the joint venture and will fund the research and development of products in a 50-50 manner. Popper said the companies hope to have their first product on the market in the second half of 2000.

The companies estimate the worldwide market for molecular diagnostics is $600 million to $700 million in 1999 and will grow to $1.5 billion to $3 billion in 2004. The preanalytical portion of the market constitutes approximately 10 percent to 20 percent of the total.

Popper said the venture intends to serve the preanalytical needs of both the clinical and research sides of the pharmacogenomics and pharmacogenetics industries.