Follow the Money to Medical Devices & Diagnostics
Spotlight on Genalyte Inc.
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.
- Genalyte was founded in 2007
- Corporate Headquarters: San Diego, CA
- 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.
EU – CE Mark approval
- 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
|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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