Business Name: Cepheid
Business Genre:
Business Description:

Diagnostics company, producer of “molecular systems and tests for organisms and genetic-based diseases” [4].

City: San Francisco Bay Area
State: CA
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]. Includes Sample Processing Control and Probe Check Control, both of which must produce expected results for test to be considered valid [2]. Recommends use of external positive and negative controls, or other authorized controls (ex: SeraCare AccuPlex™ Reference Material Kit, catalog number 0505-0126) [2, 5]. Reported 100% (83.9% – 100%) sensitivity (at 2x limit of detection) and 100% (88.7% – 100%) specificity [5].
Complimentary Products Needed to Perform Test: “Xpert Xpress SARS-CoV-2 Cartridges with Integrated Reaction Tubes, disposable transfer pipettes, CD (containing assay definition file), Sample Processing Control (SPC), Probe Check Control (PCC) [2]. Additonal materails not included in kit (GeneXpert Dx, GeneXpert Infinity, or GeneXpert Xpress Systems) outlined in Instructions for Use (IFU) [2].”
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: 250 copies/mL [4]
Funding & Ownership : Private: M&A funding status. Acquired by Danaher on Sep. 6, 2016 for $4B [4].
Business Model: Cepheid directly sells molecular diagnostic tests and related products for use on their GeneXpert family of RT-PCR systems [4, 6].
IP: Patents related to GeneXpert cartridge technology: US9789481B2 (10-17-2017), patent on a cartridge for fluid sample analysis. Includes separation of cells/viruses, lysis of cells/virus, detecton of analyte [9]. US20150352545A1 (04-17-2018), patent for a container to hold cells/virus [10]. US20140004621A1 (03-18-2014), patent on “fluid control and processing system” [11]. US20140206074A1 (04-26-2016), patent for a cartridge system which can conduct a chemical reaction and which permits real-time optical detection of analyte [12].
History & Origins : Founded in 1996, focuses on producing “accurate yet easy-to-use molecular systems and test,” through automating traditonally time-consuming manual procedures [4].
Date EUA Issued: 03/20/2020 [1]
Sources: [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13]
Organization: Founders: Allen Northrup (Past CTO), Dennis H. Giesing (Past CEO), Steve Young ( Past Lead Engineering Artchitect) [4]. Danaher Leaders: Thomas P. Joyce (President, CEO); Matt McGrew (CFO) [7].
No. Tests Per Day: 4 tests/run x 1 run/0.5hours x 24 hours/day=192 samples/day (assuming POC 4-sample machine) 80 tests/run x 1 run/0.5 hours x 24 hours/day = 3840 tests/day
Time to Result: Requires less than one minute of hands-on sample preparation, positive test results “as soon as 30 minutes.” [8]. Devices available for simultaneous testing of 1, 2, 4, 16, 48, or 80 samples [13].
Test Sample Type: nasopharyngeal swab, nasal wash/aspirate when using GeneXpert Dx or GeneXpert Infinity Systems, or nasopharyngeal swabs only when using GeneXpert Xpress System [2].
Technology Overview: detects presence of RNA originating from SARS-CoV-2 in samples taken from upper respiratory system [2]
Testing Type: automated qualitative viral RNA test, RT-PCR based [2, 5]
Test Category: RT-PCR
Test Name: Xpert Xpress SARS-CoV-2 test [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: 24 years old, founded in 1996 [4]

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