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Invitrogen Aims for Theranostic Space, Files Her2 CISH Probes with FDA; Other Dx Plays in Pipeline


Invitrogen has already filed its Her2 chromogenic in situ hybridization, or CISH, probes for clearance with the US Food and Drug Administration, and is actively seeking pharmaceutical companies for whom the product can help select patient populations, a company official told Pharmacogenomics Reporter in an e-mail last week.

The move is the latest in a series of steps, most notably several acquisitions, that the multi-platform giant has taken in recent years to build a molecular diagnostics play. Invitrogen is now applying these assets to develop diagnostic tools that will eventually complement drugs with pharmacogenomic capabilities.

The company's size and scope, including its customer base and sales force, give it the potential to make a large footprint in the pharmacogenomics and theranostics fields.

The Her2 CISH probes, along with EGFR CISH probes and several immunohistochemical probes, might be suited to identify patient tumors that will respond to GlaxoSmithKline's breast cancer drug Tykerb, according to Julian Husbands, business area manager of diagnostic solutions at Invitrogen.

The company obtained the CISH probes — which are similar to FISH probes [see sidebar] — and its immunohistochemical probes when it acquired Zymed Laboratories in January 2005 for $60 million.

The Her2 CISH probes, along with EGFR CISH probes and several immunohistochemical probes, might be suited to identifying patient tumors that will respond to the drug Tykerb.

Invitrogen's search for pharma partners may explain comments Todd Nelson, Invitrogen's vice president of corporate development, made last week at the BIO 2006 meeting in Chicago. He said Invitrogen wants to "enable" pharmaceutical companies interested in working with diagnostic firms to develop drug-diagnostic companion products.

Nelson, who made his remarks during a panel discussion on molecular diagnostics, said companion products are an area of "exceptional growth," and that molecular diagnostics companies could become potential collaboration opportunities for Invitrogen.

Nelson also said he was "thrilled" that privately held companies have been developing technologies to play in the space because when their tools are ready for the market, Invitrogen "can start collaborating with them."

Though Invitrogen has not disclosed details about its plans for the diagnostics market, some comments made by other top officials shed light on the company's plans by process of elimination. For example, CEO Greg Lucier said at the JPMorgan Healthcare Conference in January that the firm has no intention of becoming a clinical diagnostics company, while its plans for the molecular diagnostics market are focused on some "high-margin areas."

If Invitrogen wanted to buy a clinical diagnostics business, it has the resources to do it, but it has no plans to take the company in that direction, Lucier added.

Invitrogen, known for its large menu of research products, including its strong reagents play, purchased eight businesses last year with an eye toward obtaining technologies that can be used in the clinical setting. Top of the list were applications for molecular diagnostics (see Pharmacogenomics Reporter sister publication BioCommerce Week 12/22/2005).

At a conference in New York in December, Lucier said that although the firm added many new pieces in 2005, the strategy was very focused. He said the plan for 2005 was to build the cell biology and proteomics businesses — areas where the firm sees science moving toward — and it did just that through the acquisitions of firms such as Dynal, Quantum Dot, and BioSource.

Other Molecular Efforts

Invitrogen is also involved in two major biomarker development efforts — both of which underline the company's goal of remaining a diagnostic "enabler."

One, with the Mayo Clinic, was announced in December 2004, and aims to create a diagnostic replacement for the prostate-specific antigen cancer test. The partners' product will be able to detect biomarkers capable of signaling cancer "years ahead of actual symptoms," according to the company's 2005 annual report.

About CISH

Similar to FISH, CISH employs DNA probes to ascertain the level of gene amplification present in sample cell tissue. However, CISH uses immunodetection chemistry, which enables researchers to use brightfield microscopy to simultaneously evaluate tissue morphology and gene status/chromosomal aberrations, "consistent with the habits and practices of pathologists," Invitrogen said in a statement.

According to the company, the method is much cheaper than FISH, because it relies on simple light microscopes and detection technology familiar to pathologists — a factor that may allow it to replace IHC testing, which is still in wide use.

Invitrogen is developing CISH kits for Her2, C-Myc, Cyclin D1, EGFR, N-Myc, and Topoisomerase II .

— CW

This year, the collaboration is slated to begin testing its molecular diagnostic panel against the common PSA test, which will result in a formal clinical trial aimed at achieving FDA clearance for the new assay, should testing go well, the company said.

In a statement announcing the deal with the Mayo Clinic, Invitrogen said it would pay for the research and provide human protein microarrays, engineered cell lines, cell-based assays, and cloning and expression technologies.

Mayo will contribute patient samples and expertise in diagnostic assays, and will own any biomarker patents emerging from the arrangement. Invitrogen, meantime, will have the right to license technologies resulting from the collaboration either exclusively or non-exclusively, the organizations said.

Mayo Clinic researchers declined to be more specific.

In the second alliance, a multi-year program with the Fred Hutchinson Cancer Research Center in Seattle, Wash., Invitrogen plans to create an early screening tool for lung cancer using an "entirely different discovery approach" from the Mayo partnership. This collaboration was announced in September.

As part of the deal, Invitrogen will supply protein and antibody collections to the lab of Hutch researcher Sam Hanash, while the Hutch will own any patents emerging from the deal. Invitrogen will have rights to license technologies that result from the collaboration.

Officials at FHCRC declined to be more specific.

— Chris Womack ([email protected])

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