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

Primerdesign Ltd (Novacyt)

Business Name: Primerdesign Ltd (Novacyt)
Business Genre:
Business Description:

Founded in 2005 in Southhampton U School of Medicine, they design, manufacture, and supply qPCR assays for labs worldwide. Joined in Novacyt Group in 2016, which is an international diagnostics group focused on production of diagnostic kits. [2] [3]

State: Camberley
Country: United Kingdom
Data/Evidence of Effectiveness: LOD is 0.33 copies/uL. Showed negative cross-reactivity with 4 panels of other respiratory bugs. Tested on contrived clinical samples and showed 94.7% positive at 1-2x LOD, and 100% at 3x LOD. [6]
Complimentary Products Needed to Perform Test: Kit provides: master mix, primer and probe mix, resuspension buffer, template prep buffer, Rnase/Dnase free water, positive control, internal control. Still required: RNA extraction kit, PCR platform
Setting of Care: H [1]
Current Status / Clinical Development Stage / Expected Milestones: EUA approved on 3/20, kit is for sale worldwide and in US [1] [6]
Funding & Ownership : privately owned by shareholders, was acquired by Novacyt in 2016 [5]
Business Model: Produce and sell qPCR assay kits and reagents worldwide, and part of an international group that contributes as well [2] [3]
IP: proprietary tech is all trademarked [4]
History & Origins : Primerdesign Ltd. has always worked in design and production of qPCR assays, and Novacyt Group unites companies under that same goal [2] [3]
Date EUA Issued: 3/20/2020 [1]
Sources: [1] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [2] http://www.primerdesign.co.uk/about/about-primerdesign [3] https://novacyt.com/ [4] http://www.primerdesign.co.uk/about/trademarks [5] https://www.businesswire.com/news/home/20160117005110/en/Novacyt-Announces-Proposed-Acquisition-Primer-Design [6] http://www.primerdesign.co.uk/assets/files/eua_covid_19_genesig_real_time_pcr_assay_primerdesign_ifu.pdf?timestamp=1591397157
Organization: Jim Wicks: Managing Director [5]
Time to Result: 2-3 hours (standard RT-PCR time) [6]
Test Sample Type: nose and throat swabs [6]
Technology Overview: RT-PCR kit that targets the RdRp gene (or ORF1ab) [6]
Testing Type: RT-PCR [6]
Test Category: RT-PCR
Test Name: Primerdesign Ltd COVID-19 genesig Real-Time PCR assay [1]
Clinical Application & Need: detect current infection from nose and throat swabs [6]

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