Quest Diagnostics Introduces HPV Specimen Self-Collection for Cervical Cancer Screening
Quest Diagnostics (NYSE: DGX) has launched a new FDA-cleared HPV self-collection solution for cervical cancer screening. The service allows patients to collect their own specimens in healthcare settings and will be available at Quest's 2,000 patient service centers starting next month.
The solution utilizes Roche's FDA-cleared HPV self-collection technology, approved for use with their cobas® HPV test in May 2024. This initiative follows Quest's successful launch of self-collection services for STIs in October 2024.
The self-collection option comes at no extra charge and aims to address the declining screening rates, with 4.4 million fewer American women receiving screenings in 2021 compared to 2019. The service is not FDA approved for at-home collection and is not intended to replace regular pelvic examinations.
Quest Diagnostics (NYSE: DGX) ha lanciato una nuova soluzione di auto-raccolta per l'HPV, approvata dalla FDA, per lo screening del cancro cervicale. Il servizio consente ai pazienti di raccogliere i propri campioni in contesti sanitari e sarà disponibile presso i 2.000 centri di servizio per pazienti di Quest a partire dal prossimo mese.
La soluzione utilizza la tecnologia di auto-raccolta HPV approvata dalla FDA di Roche, autorizzata per l'uso con il loro test cobas® HPV a maggio 2024. Questa iniziativa segue il lancio di successo da parte di Quest dei servizi di auto-raccolta per le IST nell'ottobre 2024.
L'opzione di auto-raccolta non comporta costi aggiuntivi e mira a affrontare il calo dei tassi di screening, con 4,4 milioni di donne americane in meno che hanno ricevuto screening nel 2021 rispetto al 2019. Il servizio non è approvato dalla FDA per la raccolta a domicilio e non è destinato a sostituire gli esami pelvici regolari.
Quest Diagnostics (NYSE: DGX) ha lanzado una nueva solución de auto-recolección de HPV, aprobada por la FDA, para el cribado del cáncer cervical. El servicio permite a los pacientes recolectar sus propias muestras en entornos de atención médica y estará disponible en los 2,000 centros de servicio al paciente de Quest a partir del próximo mes.
La solución utiliza la tecnología de auto-recolección de HPV aprobada por la FDA de Roche, autorizada para su uso con su prueba cobas® HPV en mayo de 2024. Esta iniciativa sigue al exitoso lanzamiento de servicios de auto-recolección para ITS por parte de Quest en octubre de 2024.
La opción de auto-recolección no tiene costo adicional y busca abordar la disminución de las tasas de cribado, con 4.4 millones de mujeres estadounidenses menos que recibieron cribados en 2021 en comparación con 2019. El servicio no está aprobado por la FDA para la recolección en el hogar y no está destinado a reemplazar los exámenes pélvicos regulares.
퀘스트 진단(Quest Diagnostics, NYSE: DGX)이 자궁경부암 검진을 위한 FDA 승인 HPV 자가 수집 솔루션을 출시했습니다. 이 서비스는 환자가 의료 환경에서 자신의 샘플을 수집할 수 있도록 하며, 다음 달부터 퀘스트의 2,000개 환자 서비스 센터에서 이용할 수 있습니다.
이 솔루션은 로슈(Roche)의 FDA 승인 HPV 자가 수집 기술을 활용하며, 2024년 5월에 cobas® HPV 테스트와 함께 사용하도록 승인되었습니다. 이 이니셔티브는 2024년 10월 퀘스트가 성공적으로 자가 수집 서비스를 출시한 이후 이루어졌습니다.
자가 수집 옵션은 추가 비용 없이 제공되며, 2019년에 비해 2021년에 440만 명의 미국 여성들이 검진을 받지 않은 문제를 해결하는 것을 목표로 하고 있습니다. 이 서비스는 자택에서의 수집을 위해 FDA 승인을 받지 않았으며, 정기적인 골반 검사를 대체할 의도가 아닙니다.
Quest Diagnostics (NYSE: DGX) a lancé une nouvelle solution de collecte autonome de l'HPV, approuvée par la FDA, pour le dépistage du cancer du col de l'utérus. Ce service permet aux patients de collecter leurs propres échantillons dans des établissements de santé et sera disponible dans les 2 000 centres de service aux patients de Quest à partir du mois prochain.
La solution utilise la technologie de collecte autonome de l'HPV approuvée par la FDA de Roche, approuvée pour une utilisation avec leur test cobas® HPV en mai 2024. Cette initiative fait suite au lancement réussi par Quest de services de collecte autonome pour les IST en octobre 2024.
L'option de collecte autonome ne comporte aucun coût supplémentaire et vise à remédier à la baisse des taux de dépistage, avec 4,4 millions de femmes américaines en moins ayant reçu des dépistages en 2021 par rapport à 2019. Le service n'est pas approuvé par la FDA pour la collecte à domicile et n'est pas destiné à remplacer les examens pelviens réguliers.
Quest Diagnostics (NYSE: DGX) hat eine neue von der FDA genehmigte HPV-Selbstentnahmelösung für das Screening auf Gebärmutterhalskrebs eingeführt. Der Service ermöglicht es Patienten, ihre eigenen Proben in Gesundheitseinrichtungen zu entnehmen und wird ab nächsten Monat in Quest's 2.000 Patientenservicestellen verfügbar sein.
Die Lösung nutzt Roches von der FDA genehmigte HPV-Selbstentnahmetechnologie, die im Mai 2024 für die Verwendung mit ihrem cobas® HPV-Test genehmigt wurde. Diese Initiative folgt dem erfolgreichen Start von Selbstentnahmeservices für sexuell übertragbare Infektionen (STIs) durch Quest im Oktober 2024.
Die Selbstentnahmeoption ist kostenlos und zielt darauf ab, die rückläufigen Screening-Raten anzugehen, da im Jahr 2021 4,4 Millionen weniger amerikanische Frauen Screenings erhielten als 2019. Der Service ist nicht von der FDA für die Sammlung zu Hause genehmigt und ist nicht dazu gedacht, regelmäßige Beckenuntersuchungen zu ersetzen.
- Expansion of diagnostic services to 2,000 patient service centers
- No additional cost for patients or health plans
- Strong demand reported for similar self-collection services launched in October 2024
- None.
Insights
Quest Diagnostics' new HPV self-collection solution represents a strategic expansion of its diagnostic services portfolio targeting an underserved market. With data showing 4.4 million fewer women receiving cervical screenings in 2021 compared to 2019, Quest is addressing a clear healthcare gap with significant market potential.
The company's mention of "strong demand" for their previous self-collection service launched in October 2024 provides important market validation for this approach. Quest's extensive network of 2,000 patient service centers creates a substantial competitive advantage through unmatched distribution capability, allowing them to rapidly scale this offering nationwide.
From a business model perspective, Quest appears focused on volume growth rather than premium pricing, offering the service at "no extra charge" to patients or health plans. This aligns with broader healthcare reimbursement trends prioritizing preventive care and improved access.
The partnership with Roche utilizing their FDA-cleared technology represents a capital-efficient approach, reducing development costs and regulatory risks while accelerating time-to-market. This service extension strengthens Quest's position in the women's health diagnostics market and demonstrates the company's commitment to its patient-centric strategy of expanding testing access.
Quest's HPV self-collection solution addresses a critical healthcare challenge - cervical cancer remains highly preventable yet claims over 4,000 American lives annually due to screening barriers. By offering self-collection, Quest provides an alternative for patients who avoid traditional screening due to discomfort, trauma, or stigma.
The clinical validity of this approach is supported by recent USPSTF draft guidelines confirming self-collection has similar accuracy to clinician-collected tests while increasing screening rates in underserved populations. This maintains diagnostic integrity while expanding access.
Quest's implementation strategy is methodical - first enabling collection in clinical settings before expanding to their service centers next month. The "no extra charge" pricing model eliminates financial barriers to adoption for both patients and providers.
The timing is particularly relevant given the 1.7% increase in cervical cancer incidence among women aged 30-44. By removing barriers to preventive screening, Quest positions itself at the intersection of addressing a public health need and capturing market opportunity.
This launch further solidifies Quest's commitment to women's health diagnostics and aligns with healthcare's broader shift toward patient empowerment and personalized care options. The electronic results delivery maintains workflow efficiency for healthcare providers while supporting the transition to digital health management.
Providers in
Quest also plans to make self-collection option available at its 2,000 patient service centers in
New solution follows company's launch of GTI self-collection option for several STIs and related conditions last fall
Physicians can now offer patients the option to collect their own specimen for HPV screening in a physician's office or other healthcare setting. The company also plans to introduce the self-collection option for patients, with a physician's order, at its 2,000 Quest patient service centers nationwide early next month. The new option builds on Quest's experience in providing patients with discrete self-collection options. The company introduced a self-collection service option for vaginitis and other genital tract infections, such as chlamydia, gonorrhea, trichomoniasis and Mycoplasma genitalium, at its patient service centers in October 2024, and has experienced strong demand for the solution since the launch.
The new offering utilizes the FDA-cleared HPV self-collection solution from Roche (SIX: RO, ROG; OTCQX: RHHBY), approved for use with Roche's cobas® HPV test in May 2024. Interested patients can opt for self-collection in clinical settings, such as a doctor's office, or other healthcare settings.
"We are seeing more demand for solutions that empower patients to take an active role in their health care," said Kathleen Valentine, Vice President and General Manager of Women's and Reproductive Health Services at Quest Diagnostics. "Cervical cancer is highly preventable when detected early, and yet, over 4,000 American women will die this year of cervical cancer primarily due to inadequate screening. Our goal is to make HPV screening more accessible and discreet for women who may otherwise skip or delay this vital preventive care test and therefore increase their risk of developing cervical cancer."
The solution is not FDA approved for at-home collection, and self-collection is not intended to replace a pelvic examination provided by a clinician. Patients should inform their healthcare provider if they suspect they are pregnant or if they have recently had symptoms of pelvic inflammatory disease (such as pelvic pain, pain with sexual intercourse, unusual vaginal discharge or bad odor). If the patient cannot self-collect a specimen, then collection should be performed in another healthcare setting, like a physician's office, where greater support can be provided. The self-collection option is available at no extra charge for the patient or health plan.
Improving access to reduce cervical cancer incidence
When testing for HPV in conventional practice, a healthcare provider collects a specimen from a patient in their office or clinic and forwards it to a laboratory for testing. With the new self-collection service, patients may self-collect from their vagina in a private room at a physician's office using a simple step-by-step guide.1 The provider will send the specimen to a nearby Quest Diagnostics testing laboratory. After testing, results will be provided to the physician and patient electronically. The physician may review the results during a separate patient visit and provide further evaluation as needed.
"The most reliable cervical cancer method is co-testing, which combines HPV and Pap testing, on a specimen collected by a skilled physician," said board-certified obstetrician and gynecologist Damian P. Alagia, MD, Senior Medical Director, Women's Health, Quest Diagnostics. "Yet, the reality is that some patients, whether due to stigma, trauma or some other factor, are not comfortable undergoing specimen collection by their OBGYN or other doctor. Giving providers and patients options is important for caring for the needs and interests of the individual patient."
Historically, ensuring routine cervical cancer screening has been challenging, with 4.4 million fewer American women receiving screenings in 2021 when compared to 2019.2 Incidence of cervical cancer in women aged 30-44 increased
Quest Diagnostics is a leader in women's and reproductive health, which includes a complete menu of solutions for screening for and diagnosing cervical cancer. For more information, visit www.QuestWomensHealth.com.
About Quest Diagnostics
Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in
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1 Collection directions will be provided for self-collections; however, some patients may experience difficulty with self-collection and may require a visit to their healthcare provider to assist with the collection. |
2 Star J, Bandi P, Siegel RL, et al. Cancer screening in |
3 American Cancer Society. Key statistics for cervical cancer. June 28, 2024. Accessed December 20, 2024. https://www.cancer.org/cancer/types/cervical-cancer/about/key-statistics.html |
4 Draft Recommendation: Cervical Cancer: Screening | United States Preventive Services Taskforce |
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SOURCE Quest Diagnostics
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