Contemporary OB/GYN week in review: FDA clears immunoassay, new elinzanetant data, and more

Thank you for visiting the Contemporary OB/GYN® website. Take a look at some of our top stories from last week (Monday, January 06, 2025 - Friday, January 10, 2025), and click each link to read and watch anything you may have missed.

FDA grants 510(k) clearance to chemiluminescence-based immunoassay

The FDA has granted 510(k) clearance to EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone, according to Revvity.

Using random-access iSYS or i10 instruments, the ChLIA assay provides a quick turnaround with superior accuracy and reliability. Technicians may provide high throughput testing with little training and expertise using the assay. Currently, it is the only ChLIA assay to receive FDA approval for direct quantitative measurement of free testosterone.

Conditions such as impotence, hypogonadism, polycystic ovarian syndrome, and additional androgenital syndromes may receive enhanced diagnostic options through the assay. Approximately 60 tests may be performed per hour, and patients will receive their first result within only 48 minutes.

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Elinzanetant found safe and effective for VMS linked to breast cancer treatment

Elinzanetant has shown safety and efficacy for the treatment of moderate to severe vasomotor symptoms (VMS) linked to breast cancer treatment, according to a recent phase 3 study published by Bayer.

The OASIS 4 trial was designed to evaluate elinzanetant’s safety and efficacy against VMS caused by adjuvant endocrine therapy in women with or at high risk of hormone-receptor positive breast cancer. There are 474 participants undergoing 52 weeks and an optional additional 2 years of investigation.

Results indicated success from elinzanetant in reaching the primary endpoints of significantly reduced frequency for moderate to severe VMS between baseline and weeks 4 and 12 when compared to placebo. The severity of VMS was also significantly reduced in patients receiving elinzanetant during this period, and VMS frequency was reduced by week 1.

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Permanent contraception use increased in US young adults following Dobbs

The proportion of young adults seeking permanent contraception has increased in the United States following the Supreme Court’s decision in June 2022 to overturn Roe v. Wade, according to a recent study from George Washington University.

Compared to May 2022, the rates of tubal sterilizations and vasectomies were increased by 70% and 95%, respectively, in August 2022 among young adults. Many survey respondents mentioned they were seeking permanent contraception because of concerns about losing abortion access or bodily autonomy.

“The Dobbs decision has had a profound effect on young adults’ reproductive choices, leading many to opt for permanent contraception in the months following the decision,” said Strasser.“While access to all contraceptive methods - including permanent ones - is critical for reproductive autonomy, young people should not feel coerced into making decisions based on fear and uncertainty surrounding their rights.”

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Revolutionizing prenatal care with point-of-care ultrasounds

Prenatal care is significantly improved by point-of-care ultrasounds (POCUS) that evaluate the viability and gestational age of first-trimester enhanced care, according to a recent article published in the Annals of Family Medicine.

The use of first-trimester POCUS allows for real time review of ultrasound results with the patient and immediate action. Risk evaluation includes a symptom review and detailed history, and uterine contents are also evaluated through POCUS. This allows the presence and gestational age of intrauterine pregnancies to be confirmed.

The rate of first-trimester emergency department visits, urgent clinic appointments, and telephone calls for concerns was reduced by 81% among patients without miscarriage following EPD-RA implementation. Additionally, the duration between initial concern and diagnosis among miscarriage patients decreased from a mean 5.8 days to 1.7 days.

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High opioid use disorder and severe maternal morbidity rates reported among Medicaid patients

Severe maternal morbidity (SMM) risk is significantly increased among pregnant patients with opioid use disorder (OUD) enrolled in Medicaid, according to a recent study published in JAMA Network Open.

There were 96,309 Medicaid enrollees with OUD diagnosed before live birth during the study period, encompassing 108,975 deliveries. An overall mean OUD rate of 324.8 per 10,000 live births was reported in this population.

The mean SMM rate of Medicaid enrollments with OUD across states was 291.1 per 10,000 live births when excluding blood transfusions. Adult respiratory distress syndrome was the most common SMM, comprising 23.2% of cases. This was followed by sepsis at 14.1%, ventilation at 13.8%, acute heart failure at 13.4%, and eclampsia at 12.9%.

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