"Can we Learn to Love Diagnostics?" asks Roche's New Dx Chief

Well, not exactly love, but care more about them, at least? This is what Daniel O’Day, the newly installed head of Roche’s diagnostics division, asked an audience of analysts attending Roche's annual results meeting in London last week.

Appointed in September 2009, O'Day, of course, wants the answer to be 'yes'. But the analysts may have appeared less than enthusiastic.

O'Day has a point, though: with personalized medicine heralded as the holy grail of health care, someone has to inject enthusiasm and commitment into converting ideas into solid products.

Unlike most of his pre-decessors (including, most recently, Juergen Schwiezer), O’Day has apparently spent more years in pharma than in diagnostics. He has held various positions within Roche Pharma since 1987, before becoming head of Roche Molecular Diagnostics in the US in 2006. This dual background in both sides of the business means O'Day could be the man to raise the profile of Dx.

Critically, he also has the backing of other Roche execs, who believe the “pull” from clinicians demanding personalized-medicine tests will make it an attractive, i.e. lucrative, business to be in.

Okay, so many companies, including Roche, have said, or at least believed, that for years. But it probably helps that Roche's CEO Severin Schwan worked for a decade in the diagnostics side of the business (and before that in finance), before taking the top-spot in June 2008.

At the moment, the problem with diagnostics and instruments in general is their rapid commoditization, as laboratories continually demand higher-throughput screens at ever-lower costs.

Within Roche, having pharma working closely with diagnostics on personalized medicine can apparently pay dividends for the instrument guys--in the sense that pharma can help them get their way from the corporate powers-that-be. For instance, the company recently invested in a new technology platform because the pharma side wanted it. Diagnostics, meanwhile, was having difficulty justifying the expense.

That example says a lot about the current pecking order, however, even though it's admittedly a good sign for the future of Rx-Dx collaboration. Meanwhile, though, Roche is putting its money where its mouth is: it has up to 40 companion diagnostics in development with specific pharmaceutical products.

And indeed, starting parallel development of a drug and a companion diagnostic early on (rather than having drug firms clamor for a diagnostic once their product is close to, or on, the market) makes sense. It's something stand-along diagnostics firms like the UK's DxS (part of Qiagen since last year) have been calling for, unsurprisingly enough.

Rx-Dx tie-ups are happening, though. In July 2009, GlaxoSmithKline and Abbott announced that they would develop a companion diagnostic for GSK's investigational MAGE-A3 immunotherapy. In 2008, DxS partnered with Amgen to develop a K-RAS companion diagnostic to predict whether a patient with metastatic colorectal cancer will respond to Vectibix.

That said, no one--likely not even O'Day--expects a sudden flood of companion diagnostics to hit the market next week, though. But the signs are that we may soon have more than Dako's Hercep-Test (launched in 1998 to help predict who would repond to breast cancer drug Herceptin) and DxS's K-RAS mutation detection kit to talk about.

--By John Davis (j.davis@elsevier.com)

image by flikrer mozzercork used under a creative commons license