NEW YORK – With new agreements with Laboratory Corporation of America and Quest Diagnostics announced last week, Roche is ramping up commercialization of its sample self-collection devices for human papillomavirus testing.

纽约——随着上周与美国实验室公司和奎斯特诊断公司新协议的宣布，罗氏正在加紧其用于人乳头瘤病毒检测的样本自采集设备的商业化进程。

The self-collection solution, which includes two devices,

自助采集解决方案，包括两个设备，

received approval

收到批准

from the US Food and Drug Administration in May for use with the firm's

来自美国食品药品监督管理局，于五月批准用于该公司的

FDA-approved Cobas HPV test

FDA批准的Cobas HPV检测

. The

。这个

molecular test

分子测试

runs on the company's Cobas 4800, 5800, and 6800/8800 systems and first received FDA approval in 2011. The test detects the presence of the DNA of HPV genotypes 16 and 18, which are responsible for the majority of cervical cancers, and reports the 12 other high-risk HPV types as a combined result from one sample.

运行于公司的Cobas 4800、5800和6800/8800系统，并于2011年首次获得FDA批准。该测试检测HPV基因型16和18的DNA，这两种基因型是大多数宫颈癌的致病原因，并将其他12种高危HPV类型作为单一样本的综合结果报告。

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The self-collection devices are intended for use in a clinical setting where a patient can collect their own vaginal swab sample with instructions provided by QR code or a guide from a healthcare professional, said Denise Heaney, chief medical partner for molecular solutions and infectious disease at Roche Diagnostics.

罗氏诊断分子解决方案和传染病首席医疗合作伙伴丹尼斯·希尼表示，这些自我采集装置旨在临床环境中使用，患者可以通过二维码提供的说明或医护人员的指导来采集自己的阴道拭子样本。

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For sites offering self-collection, the devices can use a swab manufactured by Copan Diagnostics or the Evalyn brush manufactured by Rovers Medical Devices, depending on patient preference. There is no difference in performance using either or both, Heaney noted.

对于提供自采样的网站，设备可以使用Copan Diagnostics制造的拭子或Rovers Medical Devices制造的Evalyn刷，具体取决于患者的偏好。Heaney指出，使用任何一种或两种设备在性能上没有差异。

Once the collection is done, the sample is resuspended into the approved viral transport media and tested in the same way a traditionally collected cervical specimen would be. Regardless of how the specimen is collected, samples are processed on the Cobas system 'exactly the same way with no differentiation,' Heaney said.

一旦收集完成，样本会被重新悬浮到经批准的病毒运输介质中，并以与传统收集的宫颈样本相同的方式进行测试。海尼表示，无论样本是如何收集的，样品在Cobas系统上都会“完全相同地处理，没有任何区别”。

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However, she noted that healthcare-collected samples are cervical specimens collected in the same way as a Pap smear, while self-collected samples are vaginal specimens.

然而，她指出，医疗收集的样本是以与巴氏涂片相同的方式收集的宫颈标本，而自我收集的样本是阴道标本。

Roche's intent with the launch of its self-collection solution and its agreements with large reference laboratories like Labcorp and Quest is to 'broaden access to care' and improve accessibility. Self-collection 'allows us to … meet the patient where they are,' she said.

罗氏推出其自我采集解决方案，并与Labcorp和Quest等大型参考实验室达成协议的目的是“扩大医疗的可及性”并提高可访问性。自我采集“让我们能够……在患者所在的地方为他们提供服务，”她说道。

Traditional collection can be difficult for patients for myriad reasons, including concerns around privacy and past trauma associated with sample collection, so 'the goal here is to really be able to offer something that is acceptable to those that would not normally be screened or have been underscreened,' Heaney said.

传统收集方法对患者来说可能因诸多原因而变得困难，包括对隐私的担忧以及与样本收集相关的过往创伤，因此，“我们的目标是提供一种能够被那些通常不会接受筛查或筛查不足的人所接受的选择，”希尼说道。

However, she noted that self-collection isn't intended to replace traditional collection and the standard of care. The intent is to 'increase the volume' of patients screened, 'which means that ultimately we're improving screening overall.'.

然而，她指出，自我采样并非旨在取代传统的采样方式和护理标准。其目的是“增加”接受筛查的患者数量，“这意味着我们最终将全面提升筛查水平。”

Last year, the US Preventive Services Task Force

去年，美国预防服务工作组

released draft recommendations

发布了草案建议

for cervical cancer screening that included patient-collected samples for high-risk HPV screening. The organization noted that there is 'adequate evidence' that self-collected HPV screening has similar accuracy to clinician-collected HPV screening.

用于宫颈癌筛查，其中包括患者自行采集的高危型HPV筛查样本。该组织指出，有“足够的证据”表明自采样HPV筛查与临床医生采集的HPV筛查具有相似的准确性。

Jeffrey Klausner, a professor of clinical population and public health sciences at the University of Southern California's Keck School of Medicine, echoed Heaney's comments, saying that self-collection 'makes it much easier for patients, increases privacy, and avoids the dreaded pelvic examination.'.

南加州大学凯克医学院临床人口与公共卫生科学教授杰弗里·克劳斯纳呼应了希尼的评论，他说自我采集“大大方便了患者，增加了隐私性，还避免了令人畏惧的盆腔检查。”

'The more we can give control to patients, the better,' he added. 'Patient control results in better screening and more adherence to screening.'

“我们越能让患者掌控，效果就越好，”他补充道。“患者掌控能带来更好的筛查和更高的筛查依从性。”

Laboratories can also benefit from self-collection, he noted, because there will be an increase in testing demand and labs can offer their own screening programs.

他指出，实验室也可以从自行采集样本中受益，因为检测需求将会增加，实验室可以提供自己的筛查项目。

Klausner has done projects across the globe to study self-collection, and 'in every population we have studied … women always prefer to self-collect samples.'

克劳斯纳已经在全球范围内开展了研究自我采集的项目，而且“在我们研究过的每个群体中……女性总是更喜欢自己采集样本。”

'We give patients choice, we give them control, we build trust and strengthen the patient-provider relationship,' he added.

“我们给患者选择权，给他们控制权，建立信任并加强患者与医生之间的关系，”他补充道。

Large reference laboratories can offer Roche's self-collection solution in their patient service centers, and each center that adopts the solution can choose to offer either the brush or swab or both. In a statement, Quest Diagnostics said that providers in the US can order the self-collection solution for use in their offices or other healthcare settings and noted that the solution will be available at its patient service centers starting next month.

大型参考实验室可以在其患者服务中心提供罗氏的自我采样解决方案，每个采用该解决方案的中心可以选择提供刷子、拭子或两者兼有。Quest Diagnostics在一份声明中表示，美国的医疗服务提供者可以订购这种自我采样解决方案，用于他们的办公室或其他医疗环境，并指出该解决方案将从下个月开始在其患者服务中心提供。

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Labcorp also noted that the self-collection solution will be available by physician order and can be completed in a healthcare setting or at one of Labcorp's patient service centers.

Labcorp 还指出，自我采集解决方案将由医生开处方提供，并且可以在医疗机构或 Labcorp 的患者服务中心之一完成。

While Heaney declined to comment on pricing for the solution, she said that the CPT code for HPV testing is the same regardless of how the specimen is collected and can be used for both vaginal and cervical samples. In addition, because HPV testing is preventive, most insurance plans cover it at no cost to the patient.

虽然希尼拒绝就该解决方案的价格发表评论，但她表示，无论样本如何采集，HPV检测的CPT代码是相同的，并且可以用于阴道和宫颈样本。此外，由于HPV检测属于预防性措施，大多数保险计划都涵盖此项检测，患者无需支付费用。

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Roche is one of two firms with an FDA-approved self-collection solution for HPV testing — the other, Becton Dickinson, has also received

罗氏是拥有FDA批准的HPV检测自收集解决方案的两家公司之一——另一家是Becton Dickinson，也已获得批准。

Health Canada approval

加拿大卫生部批准

for self-collection. Last year, a

用于自助结账。去年，一个

five-year pilot study

五年试点研究

conducted by MD Anderson researchers and Texas-based federally qualified health center Su Clinica began to evaluate BD's self-collection solution in a clinical setting.

由MD安德森研究人员和德克萨斯州联邦合格健康中心Su Clinica进行的试验开始在临床环境中评估BD的自我收集解决方案。

Heaney noted that Roche is exploring broader self-collection solutions for other diseases beyond HPV, including sexually transmitted infections.

希尼指出，罗氏公司正在探索除HPV以外其他疾病的更广泛的自我采集解决方案，包括性传播感染。

Barbara Van Der Pol, director of the University of Alabama at Birmingham STD Diagnostics Laboratory, said via email that expanding self-collection in clinical settings to at-home collection for samples to be sent to laboratories is the 'next step in the process of expanding access to both HPV and other STI screening services.' .

阿拉巴马大学伯明翰分校性传播疾病诊断实验室主任芭芭拉·范·德·波尔通过电子邮件表示，将临床环境中的自我采集扩展到家庭采集以将样本送至实验室，是“扩大HPV及其他性传播感染筛查服务可及性的下一步。”