Nanogen Inc., a privately held diagnostic company, announcedtoday that it has raised $3.5 million in its first round of venturefinancing. The San Diego company is developing DNA-baseddiagnostic tests that use a combination of electronic microchipmanipulation and biotechnology to detect a wide range ofgenetic and infectious diseases.

Investors included Enterprise Partners, Kleiner PerkinsCaufield & Byers and Howard Birndorf. Nanogen, founded in1992, was launched with seed capital provided by Birndorf andEnterprise Partners.

The company also announced the appointment of its seniormanagement. Tina Berger Nova, Nanogen's president and chiefoperating officer, comes to the company from PrizmPharmaceuticals, where she was vice president and chiefoperating officer. Glen Evans, the company's vice president ofmolecular biology and medical director, and who developed thecompany's technology, is on sabbatical from the Salk Institute.

Berger Nova told BioWorld that Nanogen intends to developdiagnostic devices that automatically perform all the functionsnow conducted manually in tests for many genetic andinfectious diseases. The company's electronic devices, Evansexplained, will include microchips that contain DNA and canelectronically manipulate the biochemical molecules introducedto them. He distinguished this approach from the one used byAffymetrix in its very large-scale immobilized polymersynthesis (VLSIPS) technology, which relies on a silicon chipcontaining thousands of distinct DNA probes that cab be used todetect particular gene sequences.

Nanogen ultimately hopes its chip will also contain thousandsof distinct segments, Evans said, but the company believes itsdevice will be unique in that it will actually manipulate themolecules that interact with the DNA. Nanogen hopes to designrapid, efficient and relatively inexpensive tests that removethe need for sample preparation (such as centrifugation) andgene amplification. Ultimately, Evans said, the device wouldaccept a tissue, blood or sputum sample and within minutesdetermine if the donor had any of thousands of genetic orinfectious disorders.

Berger Nova said the company is not yet sure how its devicewill proceed through the regulatory process at FDA. She saidNanogen plans to prepare for a pre-marketing approvalapplication (PMA) in the course of its development, but mayinstead be able to submit a 510(k) marketing clearance.

Nanogen is one of several companies founded by Birndorf, whois president of Birndorf Biotechnology Development. He was co-founder of Ligand Pharmaceuticals, Gen-Probe Inc., HybritechInc. and Idec Pharmaceuticals Corp., and was involved in theformation of Gensia Pharmaceuticals Inc.

-- Karl A. Thiel Business Editor

(c) 1997 American Health Consultants. All rights reserved.