Ipsum Diagnostics, LLC

Business Name:
Ipsum Diagnostics, LLC
Business Genre:
Business Description:

College of American Pharmacists (CAP)-accredited national reference laboratory, including anatomical and molecular diagnostics divisions [5].

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 [2]. Kit contains internal control, positive extraction control, negative extraction control, and no template (negative) control, which must all generate epected results for test to be considered valid [3]. Reported 100% (95% CI: 90.4% – 100%) sensitivity and 100% (95% CI: 88.7% – 100%) specificity [6].
Complimentary Products Needed to Perform Test:
RNase P (RP) control in clinical samples (internal control), positive extraction control (contains DNA sequence of nCoV nucleoplasmid gene), negative extraction control (previously captured negative patient sample), no template (negative) control (nuclease-free, molecular grade water) [3]. According to EUA summary, “The COV-19 IDx assay is to be used with the KingFisher Flex nucleic acid extraction systems using the Omega Bio-Tek Mag-Bind Viral DNA/RNA 96 Kit and QS12 instrument with software version 1.2.2.,” and thus requires specific RT-PCR equipment (the QS12 instrument) [6].
Current Status / Clinical Development Stage / Expected Milestones:
Not FDA cleared/approved; FDA approved to meet EUA criteria [3]. Under EUA, cGMP requirements have been waived [3]; for in vitro diagnosis of SARS-CoV-2 infection [3]. Currently available for purchase[4].
8.5 copies/uL x 1000uL/mL=8,500 copies/mL [6]
Funding & Ownership :
Information not available
Business Model:
Reference lab which conducts specialized diagnostic patient services for profit [5].
History & Origins :
Reference laboratory specializing in performance of molecular/RT-PCR diagnoses [5, 7].
Date EUA Issued:
04/01/2020 [1]
[1] [2] [3] [4] [5] [6] [7]
Colin Rogers (CEO, Co-founder); Lauren Bricks (COO, Co-Founder); Elizabeth Brunelli (Quality Director); Henry Skelton, MD, FCAP (Laboratory Medical Director); Steven I. Marlowe, MD, FACP, FIDSA (Medical Director, Molecular Diagnostics); [5]
No. Tests Per Day:
1,000-4,000 tests/day [4]
Time to Result:
FDA approved Ipsum Diagnostics to perform 1,000-4,000 tests/day, allowing for results within 24 hours [4].
Test Sample Type:
nasopharyngeal or oropharyngeal swabs [3]
Technology Overview:
detects presence of RNA originating from SARS-CoV-2 in samples taken from upper respiratory system [3]
Testing Type:
qualitative viral RNA test, RT-PCR based [3]
Test Category:
Test Name:
COV-19 IDx assay[1]
Clinical Application & Need:
A positive result indicates the patient is actively infected with the virus, and assumed to be contagious [2]
Age of Company:
information not available

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