就近期美国联邦最高法院Mayo v. Prometheus一案的判决,对美国《专利法》第101条"专利适格标的"产生的影响进行了研究。对Mayo基本案情进行介绍后,梳理了近年来美国《专利法》第101条专利适格标的范围及其检测标准的变化,指...就近期美国联邦最高法院Mayo v. Prometheus一案的判决,对美国《专利法》第101条"专利适格标的"产生的影响进行了研究。对Mayo基本案情进行介绍后,梳理了近年来美国《专利法》第101条专利适格标的范围及其检测标准的变化,指出美国专利标的物范围一直缺乏清晰、明确的界定;专利适格标的检测方法虽历经多次变革,但始终无法形成一个统一、清晰的检测标准。从法律功能、专利效力、产业发展等角度,分析了Mayo案件判决产生的影响,并就企业创新成果的保护、专利申请提出了建议。展开更多
AIM To evaluate the efficacy of quantitative fecal immunochemical test(FIT) as biomarker of disease activity in ulcerative colitis(UC).METHODS Between February 2013 and November 2014, a total of 82 FIT results, obtain...AIM To evaluate the efficacy of quantitative fecal immunochemical test(FIT) as biomarker of disease activity in ulcerative colitis(UC).METHODS Between February 2013 and November 2014, a total of 82 FIT results, obtained in conjunction with colonoscopies, were retrospectivelyevaluated for 63 patients with UC. The efficacy of FIT for evaluation of disease activity was compared to colonoscopic findings. Quantitative fecal blood with automated equipment examined from collected feces. Endoscopic disease severity were assessed using the Mayo endoscopic subscore(MES) classification. The extent of disease were classified by proctitis(E1), left sided colitis(E2), and extensive colitis(E3). Clinical activity were subgrouped by remission or active.RESULTS All of 21 patients with MES 0 had negative FIT(< 7 ng/mL), but 22 patients with MES 2 or 3 had a mean FIT of > 134.89 ng/m L. The sensitivity, specificity, positive predictive value(PPV), negative predictive value(NPV) and accuracy of negative FIT about mucosal healing were 73.33%, 81.82%, 91.49%, 51.43% and 73.17%, respectively. The sensitivity, specificity, PPV, NPV and accuracy of predictive value of positive FIT(cutoff value > 100 ng/mL) about active disease status were 45.45%, 93.33%, 71.43%, 82.35%and 26.83%, respectively. Among patients with clinical remission, FIT was negative in 31(81.6%) of 38 cases, with a mean fecal hemoglobin concentration of 6.12 ng/mL(range, negative to 80.9 ng/mL) for this group of patients. Among patients with clinical active disease, FIT was negative in 16(36.4%) out of 44 cases, with a mean fecal hemoglobin concentration > 167.4 ng/mL for this group of patients. FIT was positively correlated with endoscopic activity(r = 0.626, P < 0.01) and clinical activity(r = 0.496, P < 0.01). But, FIT did not correlate with the extent of disease(r =-0.047, P = 0.676)CONCLUSION Quantitative FIT can be a non-invasive and effective biomarker for evaluation of clinical and endoscopic activity in UC, but not predict the extent of disease.展开更多
AIM: To assess the risk of relapse in ulcerative colitis (UC) patients in clinical remission using mucosal status and fecal immunochemical test (FIT) results.METHODS: The clinical outcomes of 194 UC patients in clinic...AIM: To assess the risk of relapse in ulcerative colitis (UC) patients in clinical remission using mucosal status and fecal immunochemical test (FIT) results.METHODS: The clinical outcomes of 194 UC patients in clinical remission who underwent colonoscopy were based on evaluations of Mayo endoscopic subscores (MESs) and FIT results.RESULTS: Patients with an MES of 0 (n = 94, 48%) showed a ten-fold lower risk of relapse than those with an MES of 1-3 (n = 100, 52%) (HR = 0.10, 95%CI: 0.05-0.19). A negative FIT result (fecal hemoglobin concentrations ≤ 100 ng/mL) was predictive of patients with an MES of 0, with a sensitivity of 0.94 and a specific of 0.76. Moreover, patients with a negative FIT score had a six-fold lower risk of clinical relapse than those with a positive score (HR = 0.17, 95%CI: 0.10-0.28). Inclusion of the distinguishing parameter, sustaining clinical remission > 12 mo, resulted in an even stronger correlation between negative FIT results and an MES of 0 with respect to the risk of clinical relapse (HR = 0.11, 95%CI: 0.04-0.23).CONCLUSION: Negative FIT results one year or more after remission induction correlate with complete mucosal healing (MES 0) and better prognosis. Performing FIT one year after remission induction may be useful for evaluating relapse risk.展开更多
文摘就近期美国联邦最高法院Mayo v. Prometheus一案的判决,对美国《专利法》第101条"专利适格标的"产生的影响进行了研究。对Mayo基本案情进行介绍后,梳理了近年来美国《专利法》第101条专利适格标的范围及其检测标准的变化,指出美国专利标的物范围一直缺乏清晰、明确的界定;专利适格标的检测方法虽历经多次变革,但始终无法形成一个统一、清晰的检测标准。从法律功能、专利效力、产业发展等角度,分析了Mayo案件判决产生的影响,并就企业创新成果的保护、专利申请提出了建议。
基金Supported by a 2-Year Research Grant of Pusan National University
文摘AIM To evaluate the efficacy of quantitative fecal immunochemical test(FIT) as biomarker of disease activity in ulcerative colitis(UC).METHODS Between February 2013 and November 2014, a total of 82 FIT results, obtained in conjunction with colonoscopies, were retrospectivelyevaluated for 63 patients with UC. The efficacy of FIT for evaluation of disease activity was compared to colonoscopic findings. Quantitative fecal blood with automated equipment examined from collected feces. Endoscopic disease severity were assessed using the Mayo endoscopic subscore(MES) classification. The extent of disease were classified by proctitis(E1), left sided colitis(E2), and extensive colitis(E3). Clinical activity were subgrouped by remission or active.RESULTS All of 21 patients with MES 0 had negative FIT(< 7 ng/mL), but 22 patients with MES 2 or 3 had a mean FIT of > 134.89 ng/m L. The sensitivity, specificity, positive predictive value(PPV), negative predictive value(NPV) and accuracy of negative FIT about mucosal healing were 73.33%, 81.82%, 91.49%, 51.43% and 73.17%, respectively. The sensitivity, specificity, PPV, NPV and accuracy of predictive value of positive FIT(cutoff value > 100 ng/mL) about active disease status were 45.45%, 93.33%, 71.43%, 82.35%and 26.83%, respectively. Among patients with clinical remission, FIT was negative in 31(81.6%) of 38 cases, with a mean fecal hemoglobin concentration of 6.12 ng/mL(range, negative to 80.9 ng/mL) for this group of patients. Among patients with clinical active disease, FIT was negative in 16(36.4%) out of 44 cases, with a mean fecal hemoglobin concentration > 167.4 ng/mL for this group of patients. FIT was positively correlated with endoscopic activity(r = 0.626, P < 0.01) and clinical activity(r = 0.496, P < 0.01). But, FIT did not correlate with the extent of disease(r =-0.047, P = 0.676)CONCLUSION Quantitative FIT can be a non-invasive and effective biomarker for evaluation of clinical and endoscopic activity in UC, but not predict the extent of disease.
文摘AIM: To assess the risk of relapse in ulcerative colitis (UC) patients in clinical remission using mucosal status and fecal immunochemical test (FIT) results.METHODS: The clinical outcomes of 194 UC patients in clinical remission who underwent colonoscopy were based on evaluations of Mayo endoscopic subscores (MESs) and FIT results.RESULTS: Patients with an MES of 0 (n = 94, 48%) showed a ten-fold lower risk of relapse than those with an MES of 1-3 (n = 100, 52%) (HR = 0.10, 95%CI: 0.05-0.19). A negative FIT result (fecal hemoglobin concentrations ≤ 100 ng/mL) was predictive of patients with an MES of 0, with a sensitivity of 0.94 and a specific of 0.76. Moreover, patients with a negative FIT score had a six-fold lower risk of clinical relapse than those with a positive score (HR = 0.17, 95%CI: 0.10-0.28). Inclusion of the distinguishing parameter, sustaining clinical remission > 12 mo, resulted in an even stronger correlation between negative FIT results and an MES of 0 with respect to the risk of clinical relapse (HR = 0.11, 95%CI: 0.04-0.23).CONCLUSION: Negative FIT results one year or more after remission induction correlate with complete mucosal healing (MES 0) and better prognosis. Performing FIT one year after remission induction may be useful for evaluating relapse risk.
