NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

NeuMoDx

Business Name:
NeuMoDx
Business Genre:
Business Description:

NeuMoDx is a venture-funded company that manufactures liquid handling robots for automated QPCR. [1]

City:
Ann Arbor
State:
MI
Country:
USA
Data/Evidence of Effectiveness:
“• Inclusivity: “in silico analysis mapping the assay primers and probes to all available SARS-CoV-2 sequences (n = 96) in the NCBI database as of 14 March 2020” • Cross-reactivity: in silico analysis and in vitro test on various organisms • Interfering substances: tested blood, mucin, and various nasal sprays • Clinical testing: 82 negative clinical samples and 87 contrived positive clinical samples (100% agreement) [3] “
Complimentary Products Needed to Perform Test:
“• Swabs and UTM • NeuMoDx™ 288 Molecular System or NeuMoDx™ 96 Molecular System • NeuMoDx™ Cartridge (576 tests/kit) • NeuMoDx™ Extraction Plate (384/kit) • NeuMoDx™ Wash Reagent (2 x 2L) • NeuMoDx™ Release Reagent (2 x 1L) • NeuMoDx™ Lysis Buffer 3 or alternatives • Hamilton® CO-RE Tips (300 µL) with Filters • Hamilton® CO-RE Tips (1000 µL) with Filters • Positive and negative controls [3]”
Setting of Care:
“”” Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests”” [3]”
Current Status / Clinical Development Stage / Expected Milestones:
They have an EUA approved for their SARS-CoV-2 test. Their liquid handling robots are already being sold. They have recently “received FDA 510(k) clearance for its NeuMoDx™ GBS Assay for the detection of Group B Streptococcus (GBS) DNA in antepartum pregnant women and will continue development of tests to detect and monitor sexually transmitted and infectious diseases” [3] [6]
Funding & Ownership :
They initially received $5M in Series A funding from Wolverine Venture Fund in 2012. In 2014, they received $21M in Series B funding from Baird Capital, Pfizer Venture Investments, and Venture Investors. In 2016 and 2018, they received $20M in Venture funding by a source that isn’t listed in Crunchbase. [7]
Business Model:
They are being funded by venture, but they are also selling products. [1] [7]
IP:
NeuMoDx has several patents related to their liquid handling robots [8]
History & Origins :
NeuMoDx is a venture-funded company that manufactures liquid handling robots for automated QPCR. NeuMoDx was founded in 2012 and the CEO is Jeff Williams. Many members of the board used to be a part of a biotech diagnostic company called HandyLab [2]. HandyLab was later acquired by BD for $275M. [9]
Date EUA Issued:
3/30/2020 [4]
Sources:
[1] https://www.neumodx.com/ [2] https://www.neumodx.com/talk-to-us/ [3] https://www.fda.gov/media/136565/download [4]https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [5] https://www.neumodx.com/wp-content/uploads/2019/03/JFO_2018-10-25_8009-Rev-B_NeuMoDx-96-Spec-Sheet.pdf [6] https://www.neumodx.com/our-solutions/ [7] https://www.crunchbase.com/organization/neumodx-molecular#section-overview [8] https://patents.google.com/?assignee=Neumodx+Molecular+Inc. [9] https://www.crunchbase.com/organization/handylab#section-patents-and-trademarks-by-ipqwery
Organization:
CEO: Jeff Williams [2]
No. Tests Per Day:
7 hours for either 94 or 286 samples. 24 hours/7 hours= 3 runs per day. 3 runs per day x 94 or 286= 282 or 858 depending on the machine
Time to Result:
“• Some time to set-up, maybe 30 min to 1 hour • Time to first results: ~ 80 minutes for RNA • Walk away time: 6 hours [5]”
Test Sample Type:
nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens [3]
Technology Overview:
Taqman primers for Nsp2 target (FAM), N gene (HEX), and SPC2 (Internal control, Far-Red fluorophore). Designed in a format to be easily used in their NeuMoDx™ 288 Molecular System or NeuMoDx™ 96 Molecular System [3]
Testing Type:
qualitative viral RNA test [3]
Test Category:
RT-PCR
Test Name:
NeuMoDx SARS-CoV-2 Assay
Clinical Application & Need:
acute infection [3]
Age of Company:
2012 [2]

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