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Guardant Health(GH) - 2022 Q4 - Annual Report
2023-02-23 00:00
产品推出与发展 - 公司在2022年9月推出了GuardantINFINITY血液测试,这是一种新一代智能液体活检,提供了关于肿瘤分子特征和免疫反应的新的多维洞察,以推动癌症研究和治疗的发展[14] - 公司于2022年5月推出了Shield LDT测试,以满足符合结肠直肠癌筛查资格的个体的需求。该测试使用新颖的多模态方法,在血液中检测结肠直肠癌信号,包括肿瘤释放的DNA[15] - GuardantOMNI测试覆盖了500个基因,包括与同源重组修复缺陷和免疫肿瘤应用相关的基因[29] - GuardantINFINITY是一种新一代智能液体活检测试,提供了对肿瘤分子特征和免疫反应的新的多维洞察[32] - GuardantINFINITY测试提供了比早期测试更全面的肿瘤分子特征,为研究人员提供了对肿瘤生物学、系统互动和相关免疫反应更深入和更全面的理解[33] - GuardantConnect是为临床和生物制药客户设计的集成软件解决方案,旨在将接受我们测试的患者与可能相关的临床研究联系起来[34] - GuardantINFORM是我们的实际证据平台,拥有广泛的临床基因组数据集,可加速下一代癌症治疗的研发[35] - 我们的智能液体活检平台提高了研发效率和运营杠杆,支持性能改进、新应用的交叉开发、成本节约和改善周转时间[36] - 我们的Guardant Galaxy套件的先进分析技术旨在增强我们的癌症测试组合的性能和临床效用,推动生物标志物和药物发现的下一代[37] - 我们的临床发展目标是支持我们的测试在多种肿瘤类型中进行全面基因组分析,包括作为首选替代组织测试,以在诊断后立即和疾病进展时提供治疗信息[38] 法规合规 - FDA实施了突破性设备计划,旨在加速符合条件的医疗设备的开发、评估和审查[108] - 突破性设备认定为设备开发者提供了更多与FDA工作人员的互动和及时沟通的机会[109] - FDA对实验室开发的检测测试进行监管,但通常不执行适用的监管法规[110] - FDA对伴随诊断进行监管,要求与治疗产品同时获得批准或清除[115] - FDA对医疗设备进行广泛的监管,包括设备追踪要求和市场后监测规定[117] - 欧盟对医疗设备进行监管,要求设备符合欧盟体外诊断医疗器械指令的基本要求[122] - 欧盟成员国对医疗器械的广告和促销实施了各种限制和规定[128] - 欧盟国家采用了特定的反送礼法规,限制医疗器械的商业实践,加强对医疗器械制造商提供给医疗专业人员或实体的支付和价值转移的监管[129] - 欧盟对医疗器械的监管框架正在不断发展,2017年4月通过了关于体外诊断医疗器械的新法规,旨在加强对公共健康和患者安全的保护[131] 安全与风险 - 公司在美国遵守多项联邦和州法律和法规,包括数据泄露通知法、健康信息隐私和安全法律以及消费者保护法[152] - 公司的网络安全政策包括监控和检测程序、网络安全预防措施、关键数据加密以及第三方风险管理[153] - 公司的网络安全团队由一群网络安全专业人士领导,定期向董事会全体报告信息安全和网络安全事宜[154] - 公司的安全措施无法保证不会发生重大网络攻击,成功攻击可能对业务产生重大影响[155] 企业文化与员工福利 - 公司致力于多样性、公平和包容性,员工构成中57%为种族/民族多样化,55%为女性[165] - 公司提供全面的薪酬和福利套餐,包括市场竞争力的固定和/或变动工资、广泛的股权授予和奖金、医疗、牙科、视力和人寿保险福利等[167]
Guardant Health(GH) - 2022 Q3 - Earnings Call Transcript
2022-11-04 10:52
Guardant Health, Inc. (NASDAQ:GH) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Alex Kleban - Vice President, Investor Relations Helmy Eltoukhy - Co-Chief Executive Officer AmirAli Talasaz - Co-Chief Executive Officer Mike Bell - Chief Financial Officer Conference Call Participants Puneet Souda - SVB Securities Jack Meehan - Nephron Research Matt Sykes - Goldman Sachs Kyle Mikson - Canaccord Mark Massaro - BTIG Neel Ram - Morgan Stanley Max Masucci - Cowen Patrick Donnell ...
Guardant Health(GH) - 2022 Q3 - Earnings Call Presentation
2022-11-04 07:31
Q3 2022 Earnings Call November 3, 2022 Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially differe ...
Guardant Health(GH) - 2022 Q2 - Earnings Call Transcript
2022-08-05 11:00
Guardant Health, Inc. (NASDAQ:GH) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Alex Kleban - Vice President, Investor Relations Helmy Eltoukhy - Co-Chief Executive Officer AmirAli Talasaz - Co-Chief Executive Officer Mike Bell - Chief Financial Officer Conference Call Participants Puneet Souda - SVB Securities Jack Meehan - Nephron Research Mark Massaro - BTIG Brian Weinstein - William Blair Kyle Mikson - Canaccord Matt Sykes - Goldman Sachs Daniel Macek - Stifel David We ...
Guardant Health(GH) - 2022 Q2 - Earnings Call Presentation
2022-08-05 08:37
Q2 2022 Earnings Call August 4, 2022 Safe harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different ...
Guardant Health (GH) Presents at the William Blair 42nd Annual Growth Stock Conference - Slideshow
2022-06-18 23:40
| --- | --- | |----------------------------------------------|-------| | | | | | | | | | | Transforming cancer care | | | William Blair Growth Conference June 7, 2022 | | Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that m ...
Guardant Health(GH) - 2022 Q1 - Earnings Call Presentation
2022-05-06 11:55
Q1 2022 earnings Call May 5, 2022 Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different fr ...
Guardant Health(GH) - 2022 Q1 - Earnings Call Transcript
2022-05-06 11:50
Guardant Health, Inc. (NASDAQ:GH) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Alex Kleban - VP, IR Helmy Eltoukhy - Co-CEO AmirAli Talasaz - Co- CEO Mike Bell - CFO Conference Call Participants Puneet Souda - SVB Securities Dan Arias - Stifel Jack Meehan - Nephron Research Yih-Ming Tu - Morgan Stanley Derik De Bruin - Bank of America Kyle Mikson - Canaccord Mark Massaro - BTIG Max Masucci - Cowen Patrick Donnelly - Citi Julie Qin - JPMorgan David Delahunt - Goldman Sachs Bri ...
Guardant Health(GH) - 2021 Q4 - Earnings Call Presentation
2022-02-24 17:11
Q4 & FY 2021 earnings Call February 23, 2022 Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially d ...
Guardant Health(GH) - 2021 Q4 - Earnings Call Transcript
2022-02-24 10:22
Guardant Health, Inc. (NASDAQ:GH) Q4 2021 Earnings Conference Call February 23, 2022 4:30 PM ET Company Participants Carrie Mendivil - Investor Relations Helmy Eltoukhy - Co-Chief Executive Officer AmirAli Talasaz - Co-Chief Executive Officer Mike Bell - Chief Financial Officer Conference Call Participants Tycho Peterson - JPMorgan Brian Weinstein - William Blair Tejas Savant - Morgan Stanley Puneet Souda - SVB Leerink Derik De Bruin - Bank of America Max Masucci - Cowen and Company Jack Meehan - Nephron Re ...