Follow the Money to Medical Devices & Diagnostics
Spotlight on Genalyte Inc.

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Follow the Money to Medical Device & Diagnostic Opportunities highlights a newly funded medical device or diagnostic company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

Genalyte is a U.S. private company that develops and manufactures next-generation multiplexing instruments and apparatus. It raised $36 million in a completion of a Series D venture capital investment as reported in the PharmSource Lead Sheet on November 24, 2016.

Corporate Highlights

  • Genalyte was founded in 2007
  • Corporate Headquarters: San Diego, CA

Sourcing Opportunities

  • Genalyte plans to use the proceeds to support the development and regulatory approval of the Maverick Detection System.

Device: Maverick Detection System™
Development Phase: Pilot studies
Medical Specialty: Blood or Clinical Chemistry; Diabetes/Endocrinology; Immunology/Autoimmunity
Purpose: Device – in vitro/Screening
Type: Assay/Test/Kit; Sensor/Analyzer; System/System accessory
Description: A detection system that uses a silicon chip and sensors that simultaneously analyze multiple antibody and proteins from a single small sample.

Approvals/Clearances:
EU – CE Mark approval

Previous Financings

  • August 2015: $44 million in a completed venture capital investment
  • October 2013: $1 million SBIR grant from the NIH
  • December 2012: $500,000 SBIR grant from the NIDDK

Medical Device & Diagnostics Pipeline1

Product Candidate Indication Medical Specialty Purpose Type Status
Maverick Detection System Sjogren’s syndrome/Type I diabetes Blood or Clinical Chemistry; Diabetes/Endocrinology; Immunology/Autoimmunity Device – in vitro/Screening Assay/Test/Kit; Sensor/Analyzer; System/System accessory Pilot Studies

Regulatory Approvals and Clearances

Product Candidate Region Approval/Clearance Year of Approval or Clearance
Maverick Detection System EU CE Mark 2013

1Source: PharmSource Lead Sheet

Contact Information

Genalyte, Inc. Key Officers
10520 Wateridge Circle Cary Gunn, President & CEO
San Diego, CA 92121 USA Rebecca Magdaleno, Manager, Manufacturing
Phone: +1-858-956-1200 Martin Gleeson, PhD, CSO
Fax: +1-858-658-7300 Rufus Burlingame, PhD, VP, Clinical Assay Development
Web: www.genalyte.com Chris Stampfl, Director, Marketing

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Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

More posts by Scotty Chung-Siu