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

LGC Biosearch Company

Business Name: LGC Biosearch Company
Business Genre:
Business Description:

The company was founded in 1993 and is a part of the LGC group, a international life science testing company acquired by Kohlberg Kravis Roberts in 2015. The company provides services and products for genomic analysis, including DNA/RNA synthesis, genotyping, NGS etc. [1] [2]

City: Petaluma
State: CA
Country: USA
Data/Evidence of Effectiveness: FDA Sensitivity Evaluation indicates the limit of detection ( over 95% hit rate) is 100.5 and 10 RNA copies/μl. 2021 negative clinical samples and 49 positive samples are tested to evaluate the performance. Only one positive result is invalid. [3]
Complimentary Products Needed to Perform Test: rRT-PCR enzyme mastermix, RNA extraction kit [3]
Setting of Care: permitted use under EUA in authorized laboratories [3]
Current Status / Clinical Development Stage / Expected Milestones: The company is commercial supplier of 2019-nCoV CDC-qualified probe and primer kits, including FAM-BHQ probes for RT-PCR and N1/N2 gene primer. The company introduced the Black Hole Quencher® (BHQ®) dyes in 2000. The company allows up to 100,000 tests per order for the probes and primers. [4] [5] [6] [7]
Funding & Ownership : Private; Part of the LGC group, an international life science testing company acquired and sponsored by Kohlberg Kravis Roberts [1]
Business Model: The company provides service for genomic analysis, including oligonucleotide synthesis, genotyping, NGS. The company also sells nucleic acid synthesis reagents, DNA/RNA extraction reagents, RT-PCR reagent and high-throughput instrumentations for CoV-19 diagnostics. [8]
IP: Black Hole Quenchers (US10301349B2)
History & Origins : The company has experienced the 2009 swine flu (H1N1) outbreak and scaled up their manufacturing to operate in pandemics. The company also prioritizes the orders of CoV-19 diagnostics as a response to the currrent pandemics. [7] [8]
Date EUA Issued: 02/04/2020 (updated on 03/15/2020)
Sources: [1] https://www.crunchbase.com/organization/lgc-biosearch-technologies#section-overview [2] https://www.biosearchtech.com/about-us/inside-lgc-biosearch [3] https://www.fda.gov/media/134922/download [4] https://www.biosearchtech.com/products/pcr-kits-and-reagents/pathogen-detection/2019-ncov-cdc-probe-and-primer-kit-for-sars-cov-2 [5] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-primer-probes.html [6] https://www.biosearchtech.com/support/education/fluorophores-and-quenchers/black-hole-quencher-dyes [7] https://www.news-medical.net/whitepaper/20200527/Accelerating-COVID-19-Test-Kit-Probe-and-Primer-Production.aspx [8] https://www.biosearchtech.com/covid-19/coronavirus-qpcr-probes-primers-and-pcr-reagents-resources-hub [9] https://en.wikipedia.org/wiki/Biosearch_Technologies
Organization: Tim Robinson (CEO) [9]
Time to Result: Automated 96-sample output in 3.5 hours on recommended Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument [3]
Test Sample Type: upper and lower respiratory specimens [3]
Technology Overview: RT-PCR amplification for CoV-19 N genes [3]
Testing Type: nucleic acid detection
Test Category: RT-PCR
Test Name: 2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2
Clinical Application & Need: acute infection

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