By Kirell Lakhman

Celera's Berkeley HeartLab subsidiary has been offering its KIF6 molecular diagnostic since July 2008. The cardiovascular disease-risk test is a growing money-maker for the company — Celera is three-quarters into its goal of hiring 23 new sales reps to hawk it in different US markets — and it is well regarded by most lab managers and cardiologists.

Why, then, has only one non-Celera lab in the US managed to secure a license to develop an LDT based on the gene — UCSF, which I reported last week — and only three other non-Celera facilities currently offer it on a send-out basis?

First let's look at the test and its place within Celera. BHL, the CLIA-certified arm of the company's Lab Services segment, has run approximately 160,000 KIF6 tests through October 2009, and that number is likely to grow dramatically: Approximately 60 percent of the population carry the KIF6 gene variant, which confers a 55-percent increased risk of developing primary and recurrent coronary heart disease. It also has been shown to help guide statin-prescribing decisions.

Speaking during Celera's fiscal third-quarter 2009 conference call on Oct. 28, 2009, CEO Kathy Ordonez said the company seeks to "aggressively build" its cardiovascular business — BHL's lineup in that clinical area includes 13 genetic and non-genetic assays — and has hired 17 new sales reps of an anticipated 23 to be hired by the middle of the year. A main goal of this expanded front line will be to expand the market for the KIF6 assay.

Ordonez also said Celera aims "to move its cardiovascular genetic testing beyond the secondary market and into the primary market" — from clinical labs to physicians' practices. A key driver of meeting this goal is "creating broad visibility of genetic testing through national societies and academic labs [and] partnering with major health-care networks."

And to prime the reimbursement pump, Celera last fall penned an alliance with pharmacy-benefits manager Medco to study the ability of KIF6 testing to improve statin compliance in cardiac patients.

So in the 18 months that the KIF6 test been available, why is it still not "broadly available"? As of now, UCSF, under Alan Wu, chief of San Francisco General Hospital’s Clinical Chemistry Laboratory, is the only non-Celera lab to obtain a license to develop a KIF6 LTD, while only five labs in the country (one of them BHL) are allowed to offer it on a send-out basis.

According to a person familiar with the UCSF license, "[i]t took a lot longer than we expected, but we are excited about moving forward finally."

Keep Waiting

If you're a clinical lab manager interested in a license from Celera that can enable you to develop and perform KIF6 tests, keep waiting. Labs wanting to set up send-out deals with BHL might not have to wait as long; one is expected sometime this year, and, you never know, it could be with you.

According to Celera spokesperson David Speechly the reason for the slog has to do with geography, markets, and Celera's desire to not cannibalize its own market share.

Speaking with me today, Speechly said Celera does want to see KIF6 testing offered, if not necessarily performed, in every US lab or cardiologist's office — and with 180 million people estimated to be carriers of the SNP it's no secret that it could buoy Celera's top line.

"We're working on" getting KIF6 to more patients," Speechly told me. "Our objective is to get [KIF6] out into broader use that complements, not competes with, Berkeley HeartLab."

Of course, savvy lab managers and cardiologists can hire BHL to perform the test in its Alameda, Calif., lab, but that's not the same as developing one in-house or even offering the test to all comers for BHL to perform.

According to Speechly, Celera is walking a tightrope between allowing more labs to offer the test — whether through a license or send-out agreement — and signing up labs that may not have the resources or the knowledgeable cardiology staff to ensure that they will sell enough of it.

And a principal foundation upon which the company has strung up this tightrope comprises field reports from a handful of sales reps who had for a time decamped to Las Vegas and Phoenix to learn what resourceful and knowledgeable clinical-lab and point-of-care markets look like. The reps were also shopping around a buccal swab version of the test, called StatinCheck.

On the POC side of Celera's strategy, early reports from the reps showed that "a lot of middle American physicians — general PCP guys — don't know much about genetic testing; they don't know how [KIF6] is incorporated into their decision making," Speechly said. "It took a lot of education, but what we found was that when people understood what KIF6 was ... they started ordering it. But it took time."

He told me that while "some physicians [in those two markets] really love the buccal swab" test and "for the most part" are using it, some back-up the test with a blood draw. For Celera it makes no difference whether the sample is obtained via buccal swab or blood draw; either way it makes its way to Alameda.

Armed with this information, Celera now plans to redeploy the reps, soon to number 23, to other US markets to "increase the footprint" of KIF6 testing. But it's a big country — "too big for 23 people to cover," in Speechly's words — and Celera has trained its sights only to undisclosed "metropolitan areas."

At the same time, Celera has been targeting clinical labs that would either perform the tests themselves or offer them through send-outs. This strategy has caused Celera to make another kind of strategic decision.

On the licensing front, "what we don't want to do is get into a position where we are licensing other laboratories that aren't going to do a good-enough job at creating or driving the market, and/or competing with us in a way that doesn't allow [BHL] to capture that market, so it's really on a risk-reward basis that we're assessing each potential opportunity," Speechly said.

As for UCSF, which is located just across San Francisco Bay from BHL, "they're a key opinion leader and have been a great collaborator with us on cardiovascular issues, and we don't see that as any competitive cannibalization of our market."

Asked whether Celera would come across a competing market in its goal of making KIF6 testing "broadly available," Speechly said "it might, but that's exactly what we need to assess." He added that Celera hasn't granted a license to a national lab "as yet" because the company believes it can "create the market for ourselves in an effective manner."

"We don't believe we'd have difficulty convincing any other major party to offer this test," said Speechly. "What might be difficult is to get them to offer it in a way that their nose it to the wheel, and if they don't hit a certain number of tests there will be penalties. Because no one's going to take that on. Ultimately what a third party is going to take is, 'You know what, give me a license to the test or I'll take a send-out,' and there's no commitment. It's a question of managing that risk and reward.

"This is the investment we need to make to put a stake in the ground," he added. "And once we see that type of productivity coming through, if it means we have to put another 23 people on the ground, we will."