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

NextPharma Inc./ DiaCarta

Business Name: NextPharma Inc./ DiaCarta
Business Genre:
Business Description:

“Pharmaceutical contract development and manufacturing organization” [1]

State: Workingham
Country: United Kingdom
Additional Addresses: California
Data/Evidence of Effectiveness: “Clinical sensitivity = 96.7% (95% CI, 88.6-100%), Clinical specificity = 100% (95% CI, 88.6-100%), Positive percentage agreement (PPA) =100%, Negative percentage agreement (NPV) = 100%, Overall percentage agreement (OPV) = 100%” [2,6] Sensitivity is 100 copies per mL of SARS-CoV-2 viral with a 95% confidence and expanded manufacturing capacity to 500,000 tests per week [6]
Complimentary Products Needed to Perform Test: Thermo Fisher PureLink™ viral RNA/DNA mini kit, Biosystems™ QuantStudio 5 Real-Time PCR Instrument or Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument, Spectrophotometer, centrifuge [5]
Setting of Care: CLIA certified laboratories [3]
Current Status / Clinical Development Stage / Expected Milestones: FDA-EUA approved & CE-marked [2,3]; EUA expansion to [4]
Funding & Ownership : NextPharma: Private [1]; DiaCarta: Private [7]
Business Model: NextPharma is a biotech company that specializes in “developing and commercializing product s for the early detection, diagnosis and monitoring the recurrence of cancer and viral diseases” [2]; DiaCarta Inc. is a diagnostics company that specializes in liquid biopsy diagnostics including ColoScape™, SuperbDNA™ and RadTox™ [4]
IP: N/A
History & Origins : NextPharma (distributor) and DiaCarta (developer) formed a partnership to scale up the production and distribution of DiaCarta’s COVID19 test [1,4]
Date EUA Issued: 4/8/2020 [3]
Sources: [1] https://www.crunchbase.com/organization/nextpharma; [2] http://nextpharmainc.com/ ; [3] https://www.fda.gov/media/136806/download; [4] https://diacarta.com/diacarta-sars-cov-2-test-detecting-3-viral-genes-receives-us-fda-emergency-use-authorization-test-manufacturing-expanded-to-500k-covid-19-tests-week; [5] https://www.fda.gov/media/136809/download; [6] https://diacarta.com/products/coronavirus-test ; [7] https://www.crunchbase.com/organization/diacarta
Organization: NextPharma founder & CEO until 2016: Mahmood Moshiri; DiaCarta founder/President & CEO: Aiguo Zhang
Time to Result: 2 hours [2]
Test Sample Type: nasal swabs, nasopharyngeal swabs, oropharyngeal swabs and sputum [3]
Technology Overview: RT-PCR qualitative assay that detects SARS-CoV-2 N, Orf1ab and E genes [3-4]
Testing Type: qualitative in vitro detection of viral nucleic acids [3]
Test Category: RT-PCR
Test Name: DiaCarta’s QuantiVirus™SARS-CoV-2 Test
Clinical Application & Need: acute infection [3]

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