GenMark Diagnostics

Business Name: GenMark Diagnostics
Business Genre:
Business Description:

A molecular diagnostics company focused on developing and commercializing its eSensor detection systems. [5]

City: Carlsbad
State: CA
Country: USA
Data/Evidence of Effectiveness: 65 symptomatic U.S. patients samples were used and compared with a SARS-CoV-2 RealTime RT-PCR Diagnostic Panel. The results had 94.4% positive and 100% negative agreement. [7]
Complimentary Products Needed to Perform Test: Runs on GenMark ePlex instrument and Software and ePlex SARS-CoV-2 Test cartridge [7]
Setting of Care: Authorized laboratories (certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests.) [2]
Current Status / Clinical Development Stage / Expected Milestones: Not FDA approved. FDA approved to meet EUA criteria [2]. Under EUA, current good manufacturing practice requirements is waived [2]. In vitro detection usage only [2].
LOD: 10000 [7]
Funding & Ownership : Public (Market Cap $814.687M)[5] [6]
Business Model: Sell multiplex molecular diagnostics systems and different panels that ultilize the systems [1]
IP: Patents for ePlex technologies [7]
History & Origins : The company specializes in combining nucleic acids and microelectronics to produce an electronic sensor for DNA detection. Their systems provide an automatic molecular diagnostics tools for the clinical labs. [8]
Date EUA Issued: 3/19/2020 [2]
Sources: “[1] [2] (EUA letter) [3] [4] [5] [6] [7] (IFU) [8]”
Organization: Scott Mendel (CEO), Johnny Ek (CFO), Michael Gleeson (Senior VP), Brian Mitchell (Senior VP), Eric Stier (Senior VP) [4]
No. Tests Per Day: 288 (96 tests in 8 hours * 3)
Time to Result: Results acqurired less than 2 hours; can process up to 96 tests in 8 hours [3]
Test Sample Type: nasopharyngeal swab [2]
Technology Overview: The detection is based on competitive DNA hybridization and electrochemical detection. The capture probe is bounded to the gold electrodes in the eSensor. Amplified target DNA then hybridizes to the capture probe and a complementary ferrocene-labeled signal probe. Voltammetry then is used to decide the presence or absence of the target. [7]
Testing Type: Qualitative virus test [2]
Test Category: RT-PCR
Test Name: ePlex SARS-CoV-2 Test [2]
Clinical Application & Need: Confims suspected COVID-19 infection patients [2]
Age of Company: 2010 [5]

Send Message to listing owner