Clonetics Corp. recently introduced its enhanced NeutralRedBioassay for in vitro toxicity testing, a normal human cellculture method that provides an alternative to animal testing.

The new version, called NeutralRed Bioassay PreSeeded (NRB-PS), used to screen for ocular irritancy, dermal irritancy anddrug toxicity, can reduce assay time by 50 percent andenhances testing accuracy and economy, with less potential foruser error.

The PreSeeded version is an assay that comes with cells pre-seeded in 96-well cell culture plates. This format eliminates therequirement of the old method to subculture or transfer cellsfrom T-25 flasks into 96-well plates, and so narrows thepossibility of destroying cells through over application oftrypsin (the enzyme used to detach the cells from the plastic T-25 flask).

The new version, NRB-PS, solves problems of the old version,including contamination of cells and the unevenness of seededcells. "It's more user-friendly and the user doesn't have to be acell culturalist to run the assay," said Curtis Ronci, Clonetics'director of marketing.

Based in San Diego, Clonetics specializes in producing culturednormal human cells as an alternative to animal testing. "Ours isa screening assay, so you don't need to use animals in the firstscreen," said Jeffrey Janus, marketing research manager.

According to Clonetics, cell culture systems provide quicker,more sensitive and less-expensive results than traditionalwhole animal studies.

Janus told BioWorld that Clonetics' tests, at $20 per compound,are much cheaper than using animals, which may cost up to$400 each.

Clonetics' alternative in vitro testing products are currentlysold without FDA approval and companies using the productsdevelop their own standards in-house. "Alternative methodsare slowly gaining acceptance," Ronci said. "It's an emergingmarket that I think will be significant."

-- Michelle Slade Associate Editor

(c) 1997 American Health Consultants. All rights reserved.