随着子宫内膜癌死亡率上升，一种侵入性更小的检测手段正在研发中。
The development of a less invasive procedure comes as the death rate from endometrial cancer is increasing.
对于出现异常阴道出血的女性而言，排除子宫内膜癌至关重要。医生长期以来主要依靠经阴道超声检查子宫内膜厚度是否异常，以及通过子宫内膜组织活检来判断是否存在癌变或癌前病变。
For women experiencing abnormal vaginal bleeding, ruling out endometrial cancer is critical. Doctors have long relied primarily on transvaginal ultrasounds to examine the thickness of the uterine lining for abnormalities, as well as on endometrial tissue biopsies to determine whether cancer or precancerous changes are present.
但这两种手段都可能让人感到不适甚至疼痛，且子宫内膜活检并不总能获得充足的组织样本——在绝经后女性中，这一比例约为30%。有时子宫内膜过薄，有时临床医生难以将器械通过狭窄的宫颈。一种侵入性小得多的检测手段或许即将问世。
But both procedures can be uncomfortable and even painful, and endometrial biopsies do not always yield adequate tissue samples — including about 30 percent of the time in postmenopausal women. In some cases, the uterine lining is too thin. In others, clinicians can have difficulty passing instruments through a narrow cervix. A much less invasive test may be on the horizon.
这种阴道拭子检测由分子诊断公司PinkDx开发，以临床医生采集的拭子为第一步，用于检测子宫内膜癌。它面向已出现症状的女性，包括绝经后出血者。
This vaginal swab test, developed by the molecular diagnostics company PinkDx, uses a clinician-collected swab as a first step to detect endometrial cancer. It’s intended for women who already have symptoms, including postmenopausal bleeding.
子宫内膜癌死亡率一直在攀升，部分原因是侵袭性非子宫内膜样子宫癌亚型增加，且这类亚型对黑人女性的影响不成比例。
The death rate from endometrial cancer has been climbing, driven in part by an increase in aggressive non-endometrioid uterine cancer subtypes disproportionately affecting Black women.
侯医生说：“我认为有很多研究致力于探索是否有办法降低门槛，让女性获得所需的诊断性检测。”
“I think there’s a lot of research effort in trying to figure out if there is a way to lower the barrier to get women the kind of diagnostic testing they need,” Hou said.
侯医生是PinkDx“PROACTION”临床验证研究在哥伦比亚大学欧文医学中心的主要研究者，该中心是美国参与该研究的16个站点之一。公司计划招募约3000名参与者。
Hou is the principal investigator for PinkDx’s PROACTION clinical validation study at Columbia’s Irving Medical Center, one of 16 U.S. sites involved in the study. The company set out to enroll about 3,000 participants.
为开发这项检测，PinkDx首先必须确定最可靠且侵入性最小的样本采集方法。研究人员分析了27名接受子宫切除术女性的样本。
To develop the test, PinkDx first had to determine the most reliable and least invasive method for collecting the sample. Researchers analyzed samples from 27 women undergoing hysterectomies.
随着子宫内的癌细胞死亡，侯某表示，它们会脱落携带肿瘤分子指纹的 DNA 和 RNA 片段。这些片段可能落入阴道，在那里有可能被拭子采集并检测出癌症迹象。
As cancer cells in the uterus die, Hou said, they shed fragments of DNA and RNA that carry a molecular footprint of the tumor. Those fragments can drop into the vagina, where they potentially can be picked up by a swab and tested for signs of cancer.
温岑森指出，PinkDx 正试图通过其多中心研究实现这一点。
PinkDx is trying to do this with its multisite study, Wentzensen noted.
该公司同时关注灵敏度——即检测出癌症存在的能力——和特异性——即准确识别出未患癌女性的可靠程度。就后一指标而言，数值越高，虚假警报越少。
The company is focusing on both sensitivity, meaning how well the test detects the presence of cancer, and specificity, meaning how reliably the test identifies women who don’t have cancer. On that latter measure, the higher the number, the fewer false alarms.
官员称，初步结果达到了 90% 或更高灵敏度以及至少 50% 特异性的目标。如果这些结果经得起验证，将符合温岑森设定的基准，足以考虑将该拭子检测作为第一步，帮助女性避免更具侵入性的检查。他说，该检测可使“一半人群免于做活检”。
Officials said preliminary results are meeting the target of 90 percent or higher sensitivity and at least 50 percent specificity. If those results hold up, they’d meet the benchmarks Wentzensen would set to consider the swab as a first step that could help women avoid more invasive testing. The test could spare “half of the population from doing the biopsy,” he said.
他指出，检测呈阳性的女性可能仍需做活检，或许还要进一步检查。检测结果为阴性的女性仍建议随访医生，特别是异常出血持续存在时。许多良性疾病也会导致此类出血，包括子宫肌瘤、息肉和围绝经期变化。
Women who test positive would probably need a biopsy and perhaps further testing, he noted. Those who receive negative results would still be advised to follow up with their doctor, particularly if abnormal bleeding persists. Numerous benign conditions also can cause such bleeding, including fibroids, polyps and perimenopausal changes.
目前的临床验证研究预计将于今年结束。PinkDx 计划将该拭子作为实验室自建诊断检测提供，样本在其自有临床实验室分析。安德森预计将于明年初完成美国医疗保险和医疗补助服务中心的认证，届时公司可于 2027 年中旬向患者提供该检测。
The current clinical validation study is expected to conclude this year. PinkDx plans to offer the swab as a laboratory-developed diagnostic test, with samples analyzed in its own clinical laboratory. Anderson expects to complete certification through the Centers for Medicare and Medicaid Services by early next year, which would allow the company to make the test available to patients by mid-2027.
温岑森对这一时间表评价道：“雄心勃勃，但非不可能”，前提是更大规模的研究证明该方法行之有效。
“It’s ambitious. It’s not impossible,” Wentzensen said of the timeline, providing that the larger study shows the approach works.
尽管该测试不需要美国食品药品监督管理局的批准，但肯尼迪称该公司产品开发过程“非常、非常严苛”。PinkDx对每个样本进行多达1亿条读段的测序。“我们采用了一种基本上倾尽所有的方法，”她表示。“我们查看了阴道拭子中的每一个RNA转录本。”这项拭子测试是在肯尼迪和安德森的领导下开发的，两人都是PinkDx的共同创始人。
Although the test does not require FDA approval, Kennedy called the company’s product development process “very, very rigorous.”PinkDx sequences up to 100 million reads for each sample. “We take an approach where we basically pull out all the stops,” she said. “We look at every RNA transcript that is in the vaginal swab.”The swab test was developed under the leadership of Kennedy and Anderson, both co-founders of PinkDx.
在基因组诊断公司Veracyte共同工作后，两人将他们的分子诊断才华带到了这家初创企业，安德森是Veracyte的共同创始人，旨在帮助患者避免不必要的侵入性程序和手术。总部位于加利福尼亚州的PinkDx专门致力于女性医疗问题。
The two brought their molecular diagnostics acumen to the venture after working together at Veracyte, a genomics diagnostics company that Anderson co-founded to help patients avoid unnecessary invasive procedures and surgeries. PinkDx, which is based in California, works exclusively on women’s medical issues.