Motorola and Nanogen Take Their DNA Diagnostics Duel Into the Marketplace

  Motorola and Nanogen may have buried the hatchet in the courtroom, settling their patent infringement suit in July, but the two companies are now dueling in the DNA diagnostics marketplace.

Last week, both announced new assays for their chip-based platforms. Motorola Life Sciences came out with a DNA Biochip Assay that detects mutations in the Cytochrome p450 gene pathway, and announced it had shipped over 500 p450 chips along with its eSensor DNA detection system from its Pasadena, Calif., location (formerly Clinical Microsensors) to clinical diagnostics lab Sanofi-Synthelabo’s Malvern, Pa., research facility. These 36-probe chips detect mutations in the 2D6, 2C9, and 2C19 genes, all of which play a role in a patient’s ability to metabolize drugs. Sanofi-Synthelabo plans to use these systems in Phase 1 clinical trials, Motorola said.

Meanwhile Nanogen, which paid $5 million to settle the patent dispute with Motorola over their electronic DNA detection methods, announced it had internally validated its DNA-based protocol for Factor II 20210 (Prothrombin) mutation, a mutation involved in certain genetic cardiovascular disorders that relate to excessive blood clot formation, or thrombosis. The company plans to sell this test and another recently-validated test for Factor V Leiden gene mutations associated with cardiovascular disease, to CLIA (Clinical Laboratory Improvement Act) -certified laboratories for development as a “home-brew” screening test — a test that would not require further FDA approval for labs to use in diagnosing patients.

For Motorola, the shipment of the p450 protocol was a strong signal that it is ready to take the eSensor platform, which has been in beta testing for over a year, out into the marketplace to contend with Nanogen’s installed base of NanoChip platforms.

“I think were out of the beta test phase and into to the marketing trials phase,” said Tim Tiemann, Motorola Life Sciences’ director of business development for human health. ”Our business plan is predicated on getting [eSensor platforms] in the hands of clinicians in a very big way.”

The company is negotiating deals with a number of other customers, Tiemann added. In the coming months, he predicted “a steady stream of these agreements coming out on the p450 and other assays.”

Motorola is betting that price will play a large role in helping it gain the upper hand in the diagnostic DNA chip market. The eSensor 1200 platform, which reads twelve chips at a time (each of which has up to 36 different probes), sells for as little as $5,000. The larger eSensor 4800, which reads up to 48 chips at a time, sells for somewhere near $25,000. The company’s chips for the platform sell now for between $20 and $40.

These price points are significantly lower than those set by Nanogen. Nanogen’s more complex NanoChip platform, which can be configured to read chips that each have 100 probes, sells for a list price of $160,000.

Nanogen justifies this price tag with claims that its system has increased sensitivity and can detect rare mutations such as short tandem repeats and deletions.

But Motorola sees Nanogen’s system as more suited to research than clinical diagnostics.

“Other companies are trying to massage their [research] instruments into something suitable for the low-density diagnostic market whereas eSensor was specifically designed for this market,” said Tiemann.

In fact, the p450 assay that Motorola just shipped is actually more of a research assay than a diagnostic test. Affymetrix is the only other company to have produced a commercially available p450 array. This assay also avoids the FDA hurdle because it is being used for research, not actual clinical diagnostics.

Nanogen has gone further toward FDA approval of its assays than has Motorola. CEO Randy White outlined a plan back in June, wherein the company would first introduce its assays as “home-brew” diagnostic tests reimbursable under CLIA, and then use results from these homebrew tests to secure premarket approval of a test. White said Nanogen would have five home-brew tests installed by the end of 2001.

In collaborations with 13 research partners, Nanogen currently is developing tests for cancer, infectious disease, hereditary hemachromatosis, and cardiovascular disease-related mutations such as the Factor II and Factor V mutations.

Motorola has also lined up collaborations to develop content for its chips, including a research partnership with the UCLA molecular genetics laboratory and a partnership with GeneScan to develop tests for genetically modified crops.

And even though Motorola advertises a simpler, cheaper system than Nanogen, the eSensor is not yet the simple lock-and-load DNA diagnostic chip machine that could effectively bring chips into the doctor’s office. Like just about any other DNA chip device including the NanoChip workstation, the eSensor requires that users extract DNA from a sample, purify, and amplify it before loading it onto the chip.

In later versions of the chip, the company hopes to enable users to eliminate the amplification step. Still, Tiemann emphasized that a clinical laboratory technician possessed the skills necessary handle the eSensor platform. “You don’t need a PhD to be able to run or read it,” he said.

Nanogen NanoChip workstation vs. Motorola ESensor

• COST: Motorola eSensor sells at $5,000 for the 1200, which loads 12 chips at a time, and up to $25,000 for the larger 48-chip 4800. Nanogen’s system costs up to $160,000, but has been sold at prices below $100,000.

• PROBES PER CHIP: Nanogen NanoChips have 100 probes per chip, while Motorola’s eSensor platform allows for only 36.

• FLEXIBILITY: Nanogen boasts that each electrode is individually addressable, while Motorola’s 36-spot chips are pre-programmed. Nanogen also says its chips can be used for SNPs, short tandem repeats, deletions, and other genetic mutations difficult or impossible to detect on a standard chip. Motorola’s current p450 chip detects SNPs only.

— MMJ