By Kirell Lakhman

Dartmouth's Hitchcock Medical Center is two years into a novel organizational experiment. The plan has so far enabled its clinical pathology lab to save cash and keep pace with a surge in in-house demand for new pharmacogenomic drug-response and metabolism tests, according to Greg Tsongalis, director of the center's molecular pathology lab.

In 2007, with an MD population increasingly hungry for molecular tests for clinical service and clinical trials, Hitchcock scratch-built a CLIA-certified translational research lab in order to research and develop homebrews for its core clinical lab.

So far, because the tests are developed with input from the clinical lab, QC has been streamlined and the lab is able to pocket around 75 percent of the costs it would have incurred had it bought vendor-made assays, Tsongalis says.

But longer-term, the relationship with the TRL and the clinical lab could affect how the medical center develops, prescribes, and performs clinical tests ― especially pharmacogenomic assays.

In late May I met with Tsongalis in his office, which is shoehorned into a warren of small rooms and labs on the fourth floor of the Hitchcock Medical Center, which is affiliated with Dartmouth College in western New Hampshire.

The TRL, located one floor above his office, is co-directed by Tsongalis and Wendy Wells, who is interim chair of the Department of Pathology. It acts as a kind of pre-clinical test kitchen that mixes reagents, cooks up new assays, validates them, and eventually lands them on the clinical lab's test menu. The CLIA-certified lab sits one floor below Tsongalis' office.

Tsongalis says he created the TRL after noticing that more of Hitchcock's MDs were becoming eager to try the new high-complexity tests they had been hearing about at conferences and reading about in journals.

Tsongalis told me that "not long ago I'd had to knock on doors and go to meetings and say, 'Hey, we want to do this, this, and this.' But now it's just the opposite: Physicians are seeing things at clinical meetings or in the literature sometimes before we see it in our literature."

As research labs come up with new tests, "the physicians see these papers … and call me and say, 'When is this going to be available here?' So we're really scrambling to keep up" with the demand.

According to Tsongalis, "one of the biggest bangs for our buck" in the clinical lab is developing pharmagenomic-based drug-response predictors, principally for cancer drugs, which he says his lab has been creating and aggressively pitching to MDs at Hitchcock and nearby regional medical centers and labs.

He says these kinds of tests typically take priority at his TRL over pharmacokinetic/metabolism assays for, say, warfarin or 6-mercaptopurine dosing.

The TRL operates under a $600,000 budget, half of which comes from the medical center, and the rest split between grants and other kinds of revenue. Tsongalis says he expects the overall budget to increase next year to keep up with a corresponding rise in testing volume. He says the TRL has paid for itself in the two years it's been in operation.

It currently employs two molecular technologists and one histotechnologist, a pair of postdocs, and an administrator who obtains the samples, maintains databases, and other tools the lab needs. Over the past two years the TRL has transferred five or six homebrew tests to the clinical lab, which now lists them on its menu. Tsongalis says the lab's headcount and the number of tests will "at least double in size by next year. I think the size and scope of the lab will double."

Today, the Hitchcock clinical lab offers between 45 and 50 assays that range from genetic and infectious-disease tests to a variety of cancer-predisposition and cancer drug-response assays. The lab performs between 20,000 and 25,000 tests each year — "a decent number for a lab of our size."

Tsongalis says that around 40 percent of the assays the clinical lab runs originated at the TRL. He says that number is about one-third more than last year's, and that the yield is expected to rise even more in 2010. He didn't elaborate.

In the clinical lab, which employs six molecular techs, pride of place has gone to oncology. Back in Tsongalis' office, an otherwise empty white board tacked to a back wall lists a dozen genes and other targets currently being studied at the TRL.

Tsongalis explained that the TRL is currently trying to turn the tests into validated homebrews to predict efficacy for a small number of cancer inhibitors. He says these tests will be validated throughout the year, after which they will be added to the clinical lab's menu.

New targeted cancer drugs tied to certain pathways and genes "are coming on a weekly basis, almost," Tsongalis told me, "and physicians don't have anything to help them" make prescription decisions. Once the tests arm them with that ability there will be a notable increase in test requests from throughout the Hitchcock Medical Center, he said.

"We're very aggressive in setting these tests up," Tsongalis says.

Because the test menu is always growing, Tsongalis says he expects to hire additional molecular technologists next year for the clinical lab and for the TRL.