FDA Clears Point-of-Care Vaginitis PCR Panel with CLIA Waiver
The 20-minute multiplex test delivers eight results covering bacterial vaginosis, Candida species, and trichomoniasis from clinician- or self-collected swabs.
Category: Womens Health
Womens Health
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Womens Health
Latest
FDA Clears Roche PCR Test for Bacterial Vaginosis and Yeast Infections
The FDA has cleared Roche’s cobas BV/CV assay, a molecular test that detects bacterial vaginosis and Candida vaginitis from a single swab, enabling streamlined diagnosis on the cobas platform, according to Roche.
Womens Health
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New Endometrial Sampling Device Receives FDA Clearance for Cancer Detection
Utepreva LLC has received FDA clearance for its single-use endometrial sampler, which employs three sampling mechanisms to improve tissue yield for cytologic and molecular analysis in early endometrial cancer detection.
Blood Test for Endometriosis Detection Validated in Multi-Center Clinical Study
A peer-reviewed study in the Journal of Minimally Invasive Gynecology found HerAnova’s HerResolve blood assay detected 61.5% of endometriosis cases missed by imaging, with 97.5% specificity and 80% sensitivity.
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Blood Test for Endometriosis Detection Now Available at IVF Centers
HerAnova Lifesciences has launched HerResolve, the first blood-based test for endometriosis detection, at IVF centers nationwide. Validation studies show diagnostic accuracy comparable to surgical standards, according to the company.
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FDA Approves PD-L1 Test to Guide Immunotherapy in Ovarian and Related Cancers
PD-L1 testing is now cleared to help identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be eligible for anti–PD-1 therapy.
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Renew Biotechnologies to Provide Clinical Testing for New Male Infertility Diagnostic
The company will process clinical samples for Path Fertility’s NOA Guide, an epigenetic test designed to inform surgical decision-making for men with non-obstructive azoospermia.
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BillionToOne Partners with Epic to Integrate Prenatal, Oncology Tests into EHR
BillionToOne has partnered with Epic to integrate its UNITY Complete prenatal and Northstar oncology tests into Epic’s EHR system, enabling direct ordering and results delivery for healthcare providers.
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ADLM Clinical Chemistry Journal Features Maternal-Fetal Diagnostics
Special issue explores advances in noninvasive prenatal screening, molecular diagnostics, and care disparities affecting perinatal outcomes.
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Noninvasive Prenatal Screening Could Prevent Permanent Hearing Loss in Newborns, Study Finds
Study finds noninvasive prenatal screening using low-cost whole genome sequencing can identify mothers at risk for transmitting virus that causes hearing loss in newborns.
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Roche Receives CE Mark for PCR Test Targeting Bacterial Vaginosis and Candida Vaginitis
The cobas BV/CV assay aims to improve diagnostic accuracy over traditional microscopy and pH testing methods for symptomatic patients.
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Saliva-Based Endometriosis Test Shows 96% Accuracy
The test uses microRNA analysis and AI to diagnose endometriosis in women with chronic pelvic pain when imaging is inconclusive.
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FDA Grants Breakthrough Device Designation to Nanopath’s UTI Diagnostic Platform
The molecular diagnostic system can identify complicated UTI pathogens and antibiotic resistance markers at the point-of-care in approximately 15 minutes.
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Preexisting High Cholesterol in Pregnancy Linked to Elevated CV Risk
Researchers urge clinicians to integrate lipid management into prenatal care to mitigate elevated obstetric complications and cardiovascular risks.
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Fellow Health Joins Progyny Network for Home Male Fertility Testing
Partnership provides mail-in semen analysis as a covered benefit for eligible members.
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New Risk Assessment Tool Could Enhance Ovarian Cancer Detection
The tool uses results from the CA125 blood test along with a woman’s age to generate a personalized risk score for ovarian cancer.
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Natera Launches Fetal Focus Noninvasive Prenatal Test for Inherited Conditions
The new noninvasive prenatal test addresses testing gaps when biological fathers are unavailable for carrier screening by analyzing fetal DNA from maternal blood samples.
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Studies Showcase Less Invasive, More Equitable Testing for Women’s Cancers
At ADLM 2025, researchers spotlight diagnostic innovations that aim to improve gynecologic cancer detection through greater access and less invasive methods.
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