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

Hologic, Inc.

Business Name:
Hologic, Inc.
Business Genre:
Business Description:

developer and manufacturer of medical imaging, diagnostic, and surgical products, specializing in breast & skeletal health solutions, diagnostic tests, and gynecologic surgical products [5, 6].

City:
Boston
State:
MA
Data/Evidence of Effectiveness:
Health provider fact sheet states that while the test has been designed to reduce likelihood of false positive results, both false positive and false negative results are possible. Consideration of COVID-19 exposure and associated symptoms are recommended as secondary considerations to the test result [3]. Product includes an internal control and other control materails to monitor potential error [2]. Reported 100% (94.7% – 100%) sensitivity and 100% (96.6% – 100%) specificity for upper respiratory tract specimens and 100% (94.8% – 100%) sensitivity and 100% (96.6% – 100%) specificity for lower respiratory tract specimens [4].
Complimentary Products Needed to Perform Test:
” Panther Fusion Open Access RNA/DNA Enzyme Cartridges 96 Tests, Panther Fusion Internal Control-S 960 Tests, Panther Fusion SARS-CoV-2 Assay Controls, Panther Fusion Extraction Reagent-S 960 Tests, Panther Fusion Elution Buffer 2400 Tests, Panther Fusion SARS-CoV-2 Assay PPR Solution, Panther Fusion Oil 1920 Tests, Aptima Oil Reagent.” [2]. Additional materials not included in kit (including specialized Panther Fusion RT-PCR machine) are oultined in Instructions for Use (IFU) [4].
Current Status / Clinical Development Stage / Expected Milestones:
Not FDA cleared/approved; FDA approved to meet EUA criteria [2]. Under EUA, cGMP requirements have been waived [2]; for in vitro diagnosis of SARS-CoV-2 infection [2].
LOD:
0.01 TCID50/mL [4] x 53,797 copies/TCID50 (assumed from Rhinovirus copies/TCID50 [12])= 537.97 copies/mL
Funding & Ownership :
Public (Market Cap $13.938B) [5, 7]
Business Model:
Directly sells products related to diagnostics, breast and skeletal health, and gynecological surgery [8]
IP:
US7655405B2 (02-02-2010, exp. 10-29-2019). Patent for specific design of “kits and compositions” for detection of nucleic acid [11].
History & Origins :
Founded in 1985, originally focused on women’s healthcare [5]
Date EUA Issued:
03/16/2020 [1]
Sources:
[1]https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [2]https://www.fda.gov/media/136153/download [3]https://www.fda.gov/media/136154/download [4]https://www.fda.gov/media/136156/download [5] https://www.crunchbase.com/organization/hologic#section-overview [6] https://www.hologic.com/about [7]https://finance.yahoo.com/quote/HOLX/ [8] https://www.hologic.com/hologic-products [9] https://investors.hologic.com/governance/global-leadership-team/default.aspx [10]https://www.hologic.com/hologic-products/diagnostic-solutions/hologic-sars-cov-2-assays [11]https://patents.google.com/patent/US7655405B2/en?assignee=Hologic.+Inc. [12]https://www.researchgate.net/publication/284021857_Analytical_Sensitivity_Comparison_between_Singleplex_Real-Time_PCR_and_a_Multiplex_PCR_Platform_for_Detecting_Respiratory_Viruses
Organization:
Stephen P. MacMillan (Chairman, President, CEO); Monica Aguirre Berthelot (Chief of Staff); Allison Bebo (Senior VP); Patrick Brady (Senior VP); Kevin R. Thornal (Div. President, Diagnostic Solutions); Jay A. Stein (Co-founder, Chairman Emeritus, Senior VP, CTO) [9].
No. Tests Per Day:
>1,000 tests/day [10]
Time to Result:
System allows labs to run >1,000 test in 24 hours, with first results within 3.5 hours [10].
Test Sample Type:
nasopharyngeal or oropharyngeal swabs [2], lower respiratory tract specimens [4]
Technology Overview:
detects presence of RNA originating from SARS-CoV-2 in samples taken from upper respiratory system [2]
Testing Type:
qualitative viral RNA test, RT-PCR based [2]
Test Category:
RT-PCR
Test Name:
Panther Fusion SARS-CoV-2 assay [1]
Clinical Application & Need:
A positive result indicates the patient is actively infected with the virus, and assumed to be contagious [3]
Age of Company:
35 years old, founded in 1985 [5]

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