By Kirell Lakhman

KISSIMMEE, Fla. ― The good news for microRNA-based test developers: Clarient, the acquisitive cancer clinical lab, probably has its eye on you. The not-so-good news: It’s wearing binoculars.

“[I] believe in the [miRNA] technology. It’s the right thing to measure,” said Ken Bloom, chief medical officer of the Aliso Viejo, Calif.-based facility. “But I believe miRNAs are still in that research area looking for a home. When someone can tie it to a therapy, that’s when we’ll grab it.”

Bloom spoke with me on the sidelines of the annual Association for Molecular Pathology meeting, held here this week. “There have been some play already, but it hasn’t caught on yet,” he said, adding that “[w]e haven’t done anything yet with microRNAs yet. Part of the issue of miRNAs is that there are far fewer of them [compared with genes], and they appear to be significantly more robust than just looking at expression levels at genes.”

Moreover, with expression arrays, “when you get into the real clinical world and try to establish cutoff levels, and how reproducible it is, well, it’s just not,” said Bloom. “You take three cells from over here [in a tumor] and three cells from over there, and even though it’s the same tumor you get different expression levels.”

By comparison, “[t]he miRNAs appear to be much more robust.”

Asked when his lab might consider offering miRNA-based assays, Bloom told me “we’re a year out,” but didn’t elaborate. All he’d say is that “[f]rom a clinical standpoint we’re excited about them, [and] we’re looking at a variety of different [indications], such as tumor of unknown origin to trying to predict individuals at risk of pancreatic adenocarcinoma as opposed to pancreatitis.”

As it happens, Bloom and I spoke following a corporate workshop hosted by Asuragen, whose first test, an miRNA-based assay designed to help distinguish individuals with pancreatic cancer from those with pancreatitis, was quietly launched in 2008.

“For me I’m really looking for that therapy decision point,” he added.

He said Clarient’s MO is to “look for companies … that have limited funds, are starting up, have an assay but will never be able to get that assay out commercially.” In this case, he was describing Asuragen, whose presentation we had just exited. Asuragen, based in Austin, Texas, was spun out from Ambion, parts of which were acquired by Applied Biosystems in 2006.

“For us, we can bring it out in nothing flat,” he said. “Companies like Asuragen “represent the ‘big R’ in R&D; we’ll do a little bit of the research to commercialize” the assay.