Three letters are going to change the name of the game for diagnostics companies, predicts Randolph Levine, who heads up business development for Motorola’s Clinical Micro Sensors division. “DNA diagnostics is fundamentally different from the traditional diagnostics business,” he warns.
Until now, diagnostics companies have sold instruments. The future, says Levine, is in tests.
Of course he might be biased. Motorola will start shipping its new DNA diagnostic platform, the eSensor 4800, this quarter, and Levine is looking to collaborate with outifts that can provide genomic content to make it useful.
“The partner company gives us the DNA sequences they want to look for and we develop the chip with the ability to detect them,” he explains. The chip is a low-density electronic microarray that detects genetic targets using electronic circuits made of organic molecules. Motorola has already teamed up with Germany’s GeneScan to develop a kit to test for the presence of GMOs.
A Motorola plant in Pasadena will make eSensor biochip cartridges with DNA targets provided by partners, and the company will give free readers for analyzing up to 48 chips at a time to customers who purchase enough of the chips (expected to be priced at several tens of dollars apiece). The system is capable of detecting viral and bacterial infectious diseases, other pathogens, and SNPs for industrial, agriculture, and medical markets — “anywhere DNA or RNA is,” Levine says.
Levine says the product will first be pitched to non-FDA regulated customers, such as those in the agriculture industry. Motorola will not begin seeking FDA approval for the tool until mid-2002. As of yet, the ability to do DNA testing in humans is insufficient, Levine says. DNA tests for people “need to be tied to an information system,” he says. “The doctor needs to know not just what the SNPs are where they’re found, but what they mean.”
— Adrienne Burke