As a rapid near-point-of-care device, the GeneXpert is currently used as a testing solution to improve turnaround times in major health centers. For instructions see:http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. width: 11.00" %PDF-1.7 These information gaps make it labor-intensive and, in many cases, impossible to analyze the extent of public investments in health technology development. Cepheid Xpert MTB/RIF Communication September 2011. UNITAID end-of-project evaluation: TB GeneXpertScaling up access to contemporary diagnostics for TB. Reviewer #3:I would like to command the authors for this innovative research idea and execution of the work. ?{oYNMzZ^4xIS0'ffIb Z_-RY;d>LC,*xH}(9qb>>KM/d^|{hsYDz'tpVBn9tS/w>H1&&}hRe'l/:h,|u9Tup#]p N.Q zb7.oPR7>y (t\J,]zI[|b_.hmQt(R~RQ%$|Mpl2gInv&P$2vcc6Ot")U^.g1up#UIz0D6 O }emY`g6`2?]|)WT+7N=WInTj,ts? the contents by NLM or the National Institutes of Health. 3. Recognizing GeneXpert as a potentially revolutionary technology for TB testing, FIND initially approached Cepheid to form a partnership to collaboratively develop Xpert MTB/RIF, a cartridge-based assay for detection of TB and resistance to rifampicin to replace smear microscopy and culture as the initial TB test. The assay has shown excellent agreement with the Roche Cobas 6800 system [4], [5], [6], [7], [8] and laboratory-developed RT-qPCR tests [3,6]. Limited descriptions of some public sector grants/collaborations; Government R&D tax credits up to 2016. Average assay run time across the different GeneXpert Xpress assays evaluated in this study. 2019. Please note that we cannot proceed with consideration of your article until this information has been declared. John R Thomas. 1m;aQO1o.dOYHB3Rx X9Rg^Mg9Q1R|k5ROVK! Form 10-K. rpoB gene. In otherwords, it will be very helpful to know that of 252 million dollar total public investment, what was the distribution of investment into specific R&D activities for each Cepheid GeneXpert product that is currently in market? If this link does not appear, there are no attachment files.]. Grants were counted as GeneXpert funding if abstracts mentioned GeneXpert or Cepheid as a subject/collaborator, and, for grants to David Alland, where the abstract described work on a point-of-care PCR-based diagnostic (or mentioned Cepheid or GeneXpert). This price reduction has been key to expanding use of the GeneXpert platform in these countries, and, in turn, strengthening the evidence base and clinical experience in using the technology [46]. Comprehensive data on grants made by the NIH. Did any of the estimates which the authors included in the manuscript fall in to such criteria? Zhen W., Smith E., Manji R., Schron D., Berry G.J. The GeneXpert diagnostic platform (and associated assays, software, etc.) Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. Ct values shown are the average across all replicates. Your manuscript is now with our production department. Cost-effectiveness analysis of Xpert in detecting Mycobacterium tuberculosis: A systematic review, International Journal of Infectious Diseases. From 2007 to the end of 2020, FIND has collaborated with Cepheid on eight projects, of which two are ongoing. 2014. In order for the public sector to receive an adequate return on investment in the development of health technologies, it is in our view essential that public research-funding agreements with the private sector include conditions that require the sharing of manufacturing rights and know-how, transparency of the cost of manufacturing or cost of goods sold (COGS), and mechanisms to ensure fair pricing based on COGS with volume-based price adjustments. I encourage the editors to accept and publish the revised manuscript. Similarly, the GeneXpert Flu/RSV assay has shown a high level of agreement (~97%) with established laboratory-developed tests [9,10] and the BioFire FilmArray [11]. WHO meeting report of a technical expert consultation: non-inferiority analysis of Xpert MTB/RIF Ultra compared to Xpert MTB/RIF. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. Inadequate access to diagnostic testing and health-care facilities, which is particularly pronounced in resource-poor settings such as . Reviewer #2:The revised article addresses the (minor) concerns I had raised on initial review. Concordance of the BioFire FilmArray RP2.1 panel with the Xpert SARS-CoV-2/Flu/RSV assay for the detection of Influenza A, Influenza B, RSV and SARS-CoV-2. Before GeneXpert test is a highly sensitive and specific test for tuberculosis (TB) diagnosis that detects DNA sequences specific for Mycobacterium tuberculosis and rifampicin resistance i.e. DNA Amplification in a Microfabricated Reaction Chamber. Plug the external DVD drive into the hub. ). This comprises $42,077,663 in funding of projects directly developing the technology and $13,732,770 for validation projects (Fig 3). Fig. Recommendations for sample pooling on the Cepheid GeneXpert system using the Cepheid Xpert Xpress SARS-CoV-2 assay. Cepheids accounting of R&D investments was limited to the Xpert MTB/RIF assay and did not appear to cover investments in the GeneXpert platform more broadly. For each dilution, 300L was tested on the GeneXpert using either the Xpert SARS-CoV-2 assay or the Xpert SARS-CoV-2/Flu/RSV assay as per the manufacturer's instructions. All samples used for this study were ethics-exempt, anonymized, diagnostic samples. Received 2021 Feb 25; Accepted 2021 Aug 2. Ct value comparisons between different Xpert assays using clinical specimens. DARPADefense Advanced Research Projects Agency. March-In Rights Under the Bayh-Dole Act. Click on Create Test from the main menu of the GeneXpert Dx 3.Enter or verifiy the correct information for the following sections (if applicable): Patient ID Sample ID 4. The Xpert MTB/RIF is a cartridge-based nucleic acid amplification test (NAAT) for simultaneous rapid tuberculosis diagnosis and rapid antibiotic sensitivity test.It is an automated diagnostic test that can identify Mycobacterium tuberculosis (MTB) DNA and resistance to rifampicin (RIF). The sputum is mixed with the reagent that is provided with the assay, and a cartridge containing this mixture is placed in the GeneXpert machine. The GeneXpert Dx system is the first unit dose, near-point-of-care molecular device commercially available. From January 2016 to August 2018, Gene Xpert results were prospectively studied in 68 patients of clinicoradiologically suspected spinal tuberculosis (STB) and a control group (CG) of 92 patients, all of whom underwent computed tomography-guided/C-arm-guided/open surgical biopsy. Selected samples were chosen to cover a wide range of Ct values from approximately 1540. The Xpert MTB/RIF assay is a new test that is revolutionizing tuberculosis (TB) control by contributing to the rapid diagnosis of TB disease and drug resistance. We additionally identified grants by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation (Table 1). Treatment Action Group. Nasal swabs from healthy SARS-CoV-2 negative donors were collected and placed in UTM at a ratio of one swab per two mL of UTM to form a nasal matrix. This is an open access article distributed under the terms of the, GUID:76100C93-B999-4B2A-9A62-A00BEC71167A, GUID:0030FE77-4447-4A42-8607-11F12CAA0537, GUID:A442FD9B-B985-4874-87E2-4B48500E984D, GUID:31E91D90-168B-444F-973D-269817DF6B35. Enter or scan the Sample ID and Patient ID (if applicable). Cambridge Consultants, Mdecins Sans Frontires. Overall, there was a high level of concordance between assays, with 99.0% agreement for Influenza A and Influenza B, and 100% agreement for RSV (Table3). HHS Vulnerability Disclosure, Help U.S. Department of Defense. DG received a research grant from TAG as an independent researcher, and DB, LM, and SM are employees of TAG. The key role played by the public sector in R&D and roll-out stands in contrast to the lack of public sector ability to secure affordable pricing and maintenance agreements. This new multiplex Xpert SARS-CoV-2/Flu/RSV test will effectively replace existing Xpert SARS-CoV-2 and Xpert Flu/RSV assays that have been widely implemented across North America. An official website of the United States government. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests, [Note: HTML markup is below. . From the beginning of 2001 to July 2020, the USAspending.gov database lists a total of $476,554,644 in federal procurement contracts awarded to Cepheid (not inflation-adjusted; see S3 File). The test simultaneously detects Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) in less than 2 hours. This should be seen as a lower-bound estimate, as certain public investments were likely not captured due to a lack of published informationfor example, investments in early development and some military investments. Department of Defense. A). However, publicly available information on budgets and expenditures at LLNL does not report granular data on expenditures for specific projects, technologies, or expenditures by specific teams. Research activities over the past three decades at the Lawrence Livermore National Laboratory (LLNL) and FINDboth identified as key to GeneXpert development through review of Cepheid materialswere investigated further; research activities of key inventors were similarly investigated. U.S. Department of Defense. The presence of multiple viral targets did not have a notable effect on test performance or agreement between assays; as SARS-CoV-2 Ct values remained similar across both assays, regardless of the presence of Influenza A, Influenza B or RSV targets (Supplemental Table 1). The development of molecular diagnostics in the 1990s represented a significant medical advance. The site is secure. Indeed, survey data showed that already in 20142016, among 21 high-TB-burden countries, 37% were using the GeneXpert diagnostic platform for other diseases beyond TB [8]. World Health Organization. Trained, competent staff. Inclusion in an NLM database does not imply endorsement of, or agreement with, Chapter 300: PHS Licensing Policy. Public Citizen. For the period 19962007, Cepheid reported annual summary values for government sponsored research and contract revenues (the latter of which, by the companys definition, includes research grants, among other things; see Table 3 in S2 File). Availability of an Assay for Detecting, CDC. It is also called Gene Xpert because it works as its name. ZeptoMetrix (Buffalo, United States) NATrol chemically-inactivated SARS-CoV-2 virus (Cat: NATSARS-ST), at a stock concentration 1.2106cp/mL, was serially-diluted in this nasal matrix to concentrations ranging from 16 cp/mL to 1000cp/mL. PLOS authors have the option to publish the peer review history of their article (what does this mean?). Currently available testing methods are reviewed, with an emphasis on the importance of lab testing in the era of performance-driven healthcare. Requirements for GeneXpert Test 1. Another mechanism that has received attention is section 1498 of the Patent Act, which would allow the US govt to override patent rights (see e.g., https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3685413). Cepheid. Reviewer #1:This study looks at the public and philanthropic/not-for profit contributions to the development of the GeneXpert technology. 2013. The Cepheid Xpert Xpress SARS-CoV-2 assay is a rapid, real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.The Cepheid Xpert Xpress SARS-CoV-2 assay is only for use under the Food and Drug Admin. Over this period, FIND expenses on these projects totaled $6,740,785 for clinical and laboratory studies, $19,688,602 on other research and development costs, and $3,125,175 on relevant FIND internal operating expenses, such as staff and travel costs. Bethesda, MD 20894, Web Policies Other than COVID-19 technologies, grant information is not public. WHA72.8 Improving the transparency of markets for medicines, vaccines, and other health products. 302-3173, Rev. HPV testing, the Pap smear and the molecularisation of cervical cancer screening in the USA: Molecularisation of cancer screening in the USA. The Genexpert can test for a number of infectious diseases including TB & COVID. This reviewer feels that the authors work can provide some guidance (based on their experience in identifying and extracting data for this study) as to how this transparency issues can be improved, particularly for the public investment. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. Under a 2006 agreement between FIND and Cepheid for development of the Xpert MTB/RIF assay, Cepheid agreed to price cartridges based on the cost-of-goods-sold (COGS) (this includes costs of materials, labor, and overhead) plus intellectual property licensing costs and a 20 percent profit; annual independent audits of these costs; and annual volume- and COGS-based price adjustments [51]. Transfer reagent treated specimen into cartridge sample well by using a dropper. In 2010, WHO endorsed the Xpert MTB/RIF assay as the initial diagnostic test where there is clinical suspicion of multidrug-resistant (MDR) TB or HIV-associated TB; [3] in 2013, WHO expanded its endorsement of Xpert MTB/RIF as the initial test for all people with signs and symptoms of pulmonary or extrapulmonary TB; [1] in 2017, WHO endorsed Xpert MTB/RIF Ultra, a more sensitive version of the test; [4] in 2020, WHO strengthened its endorsement of Xpert TB tests to be used as initial tests for pulmonary and extrapulmonary TB; [2] and in 2021, WHO endorsed a new Xpert test for resistance to key second-line TB drugs [5]. Zed Books Ltd. Neglected Diseases, Delinquent Diagnostics. % GeneXpert technology is based on the application of microengineering and microfluidics (moving fluids through very small channels) to polymerase chain reaction technology. FINDFoundation for Innovative New Diagnostics. Comparison of commercially available and laboratory developed assays for. If you have any billing related questions, please contact our Author Billing department directly at gro.solp@gnillibrohtua. Comparison of the Cepheid Xpert Xpress Flu/RSV assay to in house Flu/RSV triplex real-time RT-PCR for rapid molecular detection of Influenza A, Influenza B and respiratory syncytial virus in respiratory specimens. Postal Service Biohazard Detection System program, Cepheid received production contracts for up to $200 million in anthrax test cartridges and associated materials in 2007, up to $112 million of anthrax test cartridges and associated materials in 2011, and a further contract in 2012 for an undisclosed amount [55]. Major advantages of the Xpert MTB/RIF assay are that. Public investments into early-stage technology development have been key to many modern technologies [14]. A landscape analysis of patents potentially relevant to GeneXpert technology was reviewed for public sector patent applicants and declarations of government funding [20].
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