Exact Sciences’ experience with the FDA and CMS parallel review program

Ridge, John R; Statz, Sandra

doi:10.1586/14737159.2015.1069184

Cited by 11 publications

(8 citation statements)

References 12 publications

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“…SOCS3 is known to inhibit cytokine signaling via Janus kinase (JAK)/signal transducers, activators of transcription [31], NFkB, and focal adhesion kinase (FAK) signaling pathways. Substantial data demonstrate the link between SOCS3 regulation of inflammation and its suppressor activity on tumor initiation and development [11, 32, 33].…”

Section: Discussionmentioning

confidence: 99%

Tumor SOCS3 methylation status predicts the treatment response to TACE and prognosis in HCC patients

et al. 2017

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BackgroundSuppressor of cytokine signaling (SOCS) 1 and 3 methylation have been associated with clinical features and outcomes of cancer patients. However, their roles in determining the treatment response to transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC) remain unknown.ResultsWe found that presence of SOCS3 methylation is significantly associated with the major clinical features of HCC patients, including tumor stage, lymph node and vascular invasion. Of note, we observed that the presence of SOCS3 methylation is closely related to TACE response. In prognosis analyses, HCC patients with SOCS3 methylation presence have a poorer prognosis indicated by lower 3-, and 5-year survival rates and shorter mean survival period, than those without. Multivariate COX analysis confirms the prognostic role of the presence of SOCS3 methylation in HCC patients receiving TACE treatment.Materials and MethodsA total of 246 HCC patients receiving TACE were enrolled in this study. Tumor samples was obtained from echo-guided fine needle aspiration and genomic DNA from tumor samples was purified. SOCS1 and SOCS3 methylation status were detected using methylation-specific polymerase chain reaction. The treatment responses to TACE of patients were evaluated after procedure and all patients were followed for prognosis analysis.ConclusionsThis finding suggests that the presence of SOCS3 methylation is a marker to predict treatment response and prognosis in HCC patients receiving TACE therapy.

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Section: Discussionmentioning

confidence: 99%

Tumor SOCS3 methylation status predicts the treatment response to TACE and prognosis in HCC patients

et al. 2017

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“…In particular, only one device (Exact Sciences' Cologuard test, a multitarget stool DNA test developed for noninvasive screening for colorectal cancer) was approved through the process. The time from premarket approval submission to the final NCD was 489 days compared to an average of 612 days for other NCDs issued in 2013 (75). While this suggested that parallel-review process could shorten the expected interval from regulatory approval to coverage determination, the experience with Cologuard was only a single case.…”

Section: Parallel Submission (Review)mentioning

confidence: 97%

Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges

2020

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The need to optimize drug development and facilitate faster access for patients has ignited discussions around the importance of improving interactions between health technology assessment (HTA) bodies and regulatory agencies. In this study, we conducted a systematic review to examine processes, progress, outcomes, and challenges of harmonization/interaction initiatives between HTA bodies and regulatory agencies. MEDLINE, EMBASE, and the International Pharmaceutical Abstracts database were searched up to 21 October 2019. Searches for gray literature (working papers, commissioned reports, policy documents, etc.) were performed via Google scholar and several institutional websites. An online cross-sectional survey was also conducted among HTA (n = 22) and regulatory agencies (n = 6) across Europe to supplement the systematic review. Overall, we found that while there are areas of divergence, there has been progress over time in narrowing the gap in evidentiary requirements for HTA bodies and regulatory agencies. Most regulatory agencies (4/6; 67%) and half (11/22, 50%) of the HTA bodies reported having a formal link for "collaborating" with the other. Several mechanisms such as early tripartite dialogues, parallel submissions (reviews), adaptive licensing pathways, and postauthorization data generation have been explored as avenues for improving collaboration. A number of pilot initiatives have shown positive effects of these models to reduce the time between regulatory and HTA decisions, which may translate into faster access for patients to life-saving therapies. Thus, future approaches aimed at improving harmonization/interaction between HTA bodies and regulatory agencies should build on these existing models/mechanisms while Ofori-Asenso et al. Improving HTA-Regulatory Interactions examining their long-term impacts. Several barriers including legal, organizational, and resource-related factors were also identified, and these need to be addressed to achieve greater alignment in the current regulatory and reimbursement landscape.

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“…Suppressor of cytokine signaling (SOCS3) is known to inhibit cytokine signaling through Janus kinase (JAK)/signal transducers, activators of transcription [3], NFkB, and focal adhesion kinase (FAK) signaling pathways.…”

Section: Egyptian Journal Of Medical Research (Ejmr)mentioning

confidence: 99%

Study of Expression of Suppressor of Cytokine Signaling 3 in Lichen Planus

El-Rifaie

Rashed

Naguib

et al. 2020

Egyptian Journal of Medical Research

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Background: Lichen planus (LP) is a mucocutaneous disease that is relatively common between adult populations. LP can present as skin and oral lesions. Objective: The present study aimed to detect the expression of SOCS3 in lichen planus of diseased patients as compared to normal control persons. Patients and methods: This study was a case control study included 30 Lichen planus patients as cases chosen from outpatients attending Dermatology Department at Beni-Suef University Hospital and 30 normal as controls calculated by sample size calculator formula.Results: In our study, LP cases and control were compared using SOCS3; to determine the cut-off value, we performed a ROC analysis. SOCS3 has perfect value for discrimination between LP cases and controls with an area under the ROC curve of 1.0 (95% CI = 0.940 to 1.000, P-value <0.0001).Best cut-off is a value of 1.5 (sensitivity = 100%, specificity = 1.0, J-index = 1.0). Conclusion: Our results were unique in studying the role of SOCS3 in skin form of LP. SOCS3 has perfect value for discrimination between LP cases and controls.

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Exact Sciences’ experience with the FDA and CMS parallel review program

Cited by 11 publications

References 12 publications

Tumor SOCS3 methylation status predicts the treatment response to TACE and prognosis in HCC patients

Tumor SOCS3 methylation status predicts the treatment response to TACE and prognosis in HCC patients

Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges

Study of Expression of Suppressor of Cytokine Signaling 3 in Lichen Planus

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