Figure 3: GeneXpert in GX I, GX II, GX IV, and GX XVI modules.<\/em><\/p>\n Since being endorsed for widespread adoption by the World Health Organization in 2010, the technology has proven effective in improving TB care in highly decentralized settings in sub-Saharan Africa and India, where weak infrastructure \u2013 poor roads, fragile cold chain, understaffed primary healthcare facilities \u2013 limits access to traditional laboratory-based services. [2]<\/a>,[3]<\/a> In 2015, GeneXpert\u2019s test menu expanded to include an Ebola Assay, which could have helped curb the outbreak in West Africa had it come to market sooner. [4]<\/a> In June 2016, the WHO approved the HIV Qualitative Assay, which is used to test HIV-infected infants for whom immediate diagnosis and treatment are critical. [5]<\/a><\/p>\n In short, this leapfrog technology is a game-changer in delivering patient impact.<\/p>\n Connectivity as Cepheid\u2019s Achilles\u2019 Heel<\/u><\/p>\n Ministries of Health have embraced GeneXpert, and POC technology broadly, with open arms. But in pursuit of harnessing big data for better health outcomes, they\u2019re increasingly demanding improved device connectivity, which enables aggregation, analysis, and management of testing data for enhanced patient linkage to care, remote device monitoring, supply chain optimization, and national program performance tracking. [6]<\/a><\/p>\n Cepheid did not design GeneXpert with inbuilt connectivity. In response, partners have developed independent solutions, such as the cloud-based GxAlert<\/a> and server-based XpertSMS<\/a>, and certain countries have built homegrown systems. South Africa, for example, successfully interfaced its fleet of nearly 300 GeneXpert devices with its national laboratory information management system. [7]<\/a><\/p>\n Figure 2: GeneXpert Network in South Africa<\/em><\/p>\n In 2015, Cepheid began piloting Remote Xpert, a proprietary connectivity solution. This represents a significant opportunity for Cepheid\u2019s business model, as an integrated solution would allow the company to capture value currently claimed by partners that offer complementary software or devices. Importantly, GeneXpert is no longer the only POC technology on the market; the pipeline is rich, and several competitors whose devices have inbuilt connectivity are nipping at Cepheid\u2019s heels. [8]<\/a> If Cepheid proves out Remote Xpert, Ministries will likely allocate resources to expand their GeneXpert fleets rather than invest in alternative devices.<\/p>\n However, from an operating model perspective, a proprietary connectivity solution presents significant challenges. Historically, Cepheid has relied largely on distributors to troubleshoot device issues and breakdowns. The possibility of owning the diagnostic system from end-to-end \u2013 diagnosis, data aggregation, device monitoring, commodity management \u2013 means Cepheid must now consider the extent to which it should directly manage in-country service and maintenance architecture. Greater Cepheid presence on the ground could improve performance of a GeneXpert fleet, as current distributors often do not provide high-quality or timely service, but the upfront capital investment and ongoing costs required to manage networks in every country would be substantial.<\/p>\n Cepheid\u2019s Next Move<\/u><\/p>\n Despite the costs associated with changing its operating model in-country, Cepheid should expedite development of its proprietary connectivity solution and move forward with establishing a stronger on-the-ground presence with the ultimate goal of capturing POC market share, as volume drives profit in this market.<\/p>\n Investment in proprietary connectivity and strengthened in-country service and maintenance networks would\u2026<\/p>\n Figure 4: GeneXpert Omni<\/em><\/p>\n [799 words]<\/p>\n <\/p>\n <\/a>Sources<\/u><\/p>\n [1] \u201cHealthcare Impact, The GeneXpert System makes a big impact,\u201d 2015, http:\/\/www.cepheid.com\/en\/healthcare-impact-uk<\/a>, accessed November 16, 2016.<\/p>\n <\/a>[2] World Health Organization, Rapid Implementation of the Xpert MTB\/RIF Diagnostic Test: Technical and Operational \u2018How-to\u2019 Practical Considerations, (Geneva: WHO, 2011).<\/p>\n <\/a>[3] N. Raizada, K.S. Sachdeva, A. Sreenivas, B. Vadera, R.S. Gupta, et al., \u201cFeasibility of Decentralised Deployment of Xpert MTB\/RIF Test at Lower Level of Health System in India,\u201d 2014, PLoS One 9(2): e89301.<\/p>\n <\/a>[4] Pinsky BA, Sahoo MK, Sandlund J, Kleman M, Kulkarni M, Grufman P, et al., \u201cAnalytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus,\u201d 2015, PLoS One 10(11): e0142216.<\/p>\n <\/a>[5] Cepheid, \u201cCepheid Announces World Health Organization Prequalification of Xpert HIV-1 Qualitative Test: Broadens Access to Critical Diagnostic Results for Infants Born with HIV,\u201d June 15, 2016, http:\/\/www.prnewswire.com\/news-releases\/cepheid-announces-world-health-organization-prequalification-of-xpert-hiv-1-qualitative-test-300284806.html<\/a>, accessed November 16, 2015.<\/p>\n <\/a>[6] J. Cowan, C. Michel, I. Manhica, C. Mutaquiha, C. Monivo, D. Saize, J. Beste, J. Creswell, A.J. Codlin, S. Gloyd, \u201cRemote monitoring of Xpert\u00ae MTB\/RIF testing in Mozambique: results of programmatic implementation of GxAlert,\u201d International Journal of Tuberculosis and Lung Disease, 2016, (20)3:335-341.<\/p>\n <\/a>[7] Wendy S. Stevens, Brad Cunningham, Naseem Cassim, Natasha Gous, and Lesley E. Scott, \u201cCloud-Based Surveillance, Connectivity and Distribution of the GeneXpert Analyzers for Diagnosis of Tuberculosis (TB) and Multiple-Drug-Resistant TB in South Africa,\u201d in Molecular Microbiology: Diagnostic Principles and Practice, 3rd Edition, Ed. by David H. Pershing, et al., (Washington, D.C.: ASM Press: 2016).<\/p>\n <\/a>[8] UNITAID, HIV\/AIDS Diagnostics Technology Landscape, 5th Edition, October 2015 (Geneva: World Health Organization, 2015).<\/p>\n <\/a>[9] Cepheid, \u201cWorld\u2019s First \u2018Go-Anywhere\u2019 Molecular Diagnostic System Unveiled at AACC: GeneXpert Omni Sets New Standard for Molecular Point of Care Testing,\u201d July 28, 2015, http:\/\/ir.cepheid.com\/releasedetail.cfm?releaseid=924107<\/a>, accessed November 16, 2016.<\/p>\n <\/a>[10] Cepheid, \u201cCepheid Targets Development of a Point of Care HIV Viral Load Test From a Few Drops of Blood,\u201d September 8, 2016, http:\/\/www.prnewswire.com\/news-releases\/cepheid-targets-development-of-a-point-of-care-hiv-viral-load-test-from-a-few-drops-of-blood-300324397.html<\/a>, accessed November 16, 2016.<\/p>\n <\/a>[11] Mark D. Perkins and Mark Kessel, \u201cWhat Ebola tells us about outbreak diagnostic readiness,\u201d May 2015, Nature Biotechnology 33(5).<\/p>\n <\/p>\n Photo Sources<\/u><\/p>\n [Photo 1: Cover Photo] Centers for Disease Control and Prevention, \u201cEbola (Ebola Virus Disease),\u201d June 22, 2016, https:\/\/www.cdc.gov\/vhf\/ebola\/<\/a>, accessed November 17, 2016.<\/p>\n![\"photo-4_xpert\"](\"https:\/\/d3.harvard.edu\/platform-rctom\/wp-content\/uploads\/sites\/4\/2016\/11\/Photo-4_Xpert-300x165.png\")
<\/a><\/p>\n![\"photo-1_xpert-in-rsa\"](\"https:\/\/d3.harvard.edu\/platform-rctom\/wp-content\/uploads\/sites\/4\/2016\/11\/Photo-1_Xpert-in-RSA-300x203.jpg\")
<\/a><\/p>\n\n
![\"photo-2_omni\"](\"https:\/\/d3.harvard.edu\/platform-rctom\/wp-content\/uploads\/sites\/4\/2016\/11\/Photo-2_Omni-300x278.jpg\")
<\/a><\/p>\n