Accessibility StatementSkip Navigation SALT LAKE CITY, Oct. 1, 2025 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker testing to help deliver information to doctors and patients, today announced the appointment of Tiffany Inglis, MD, FACOG, as Chief Medical Officer. With extensive clinical leadership expertise, Dr. Inglis will lead Sera's clinical operations to establish the company as ...

Summary of Sera Prognostics Conference Call Company Overview - **Company**: Sera Prognostics - **Industry**: Healthcare, specifically focused on pregnancy and preterm birth risk assessment - **Product**: PreTRM Test, a clinically validated test for screening risks of spontaneous premature birth [2][3][4] Key Points and Arguments Challenges in Preterm Birth - **Prevalence**: 1 in 10 babies are born prematurely, defined as birth before 37 weeks of gestation [2][3] - **Trends**: Preterm birth rates in the U.S. have increased from 9.4% in 2013 to 10.4% in 2023, indicating a double-digit compound growth rate [5] - **Healthcare Costs**: Prematurity costs the U.S. healthcare system approximately $25 billion annually [4] - **NICU Costs**: Average NICU stay costs around $4,500 per day, with extremely premature babies costing up to $20,000 per day [6] PreTRM Test Overview - **Unique Selling Proposition**: The PreTRM Test is the only clinically validated test for early prediction of premature birth, utilizing proteomics to measure biomarkers [10][15] - **Biomarkers**: The test measures the ratio of IGFBP4 and SHBG proteins to assess risk for spontaneous preterm birth [10][11] - **Timing**: The test is conducted during weeks 18 to 20 of pregnancy, integrating into standard care [11] Clinical Validation and Efficacy - **Clinical Studies**: The PreTRM Test has been validated through studies like AVERT and PRIME, showing significant reductions in NICU admissions and improved neonatal health outcomes [16][19] - **Efficiency**: The number needed to screen to avoid one NICU admission is 40, compared to 150 for traditional methods [17] - **Cost Savings**: Only four women need to be screened to avoid one NICU day stay [20] Commercialization Strategy - **Funding**: Sera Prognostics is well-funded with approximately $110 million in cash and a $30 million annual operating budget [4] - **Targeted States**: The company is focusing on six key states for commercialization, with a sales force and access team to ensure reimbursement and awareness [21][22] - **Partnerships**: Collaborations with payers and digital education channels to increase awareness among clinicians and expectant mothers [23][25] Future Outlook - **Guideline Inclusion**: Aiming for inclusion in clinical guidelines and payer coverage based on clinical evidence [21] - **Health Economic Model**: The breakeven for deploying the test could be achieved within a year, presenting data at the ISPOR Europe Conference [24] - **Community Impact**: The goal is to empower mothers and educate providers to improve health outcomes for babies [25] Additional Important Information - **Healthcare System Impact**: The implications of preterm birth extend beyond immediate healthcare costs, affecting long-term health and economic outcomes for families [6][7] - **Awareness Gap**: Only 20% of expectant mothers are informed about the risks of preterm birth during their first appointment [9] - **Technological Investment**: Sera Prognostics is investing in AI and machine learning to enhance predictive algorithms for the PreTRM Test [13][14] This summary encapsulates the critical insights from the conference call, highlighting the challenges, solutions, and strategic direction of Sera Prognostics in addressing preterm birth risks.

Company Overview - Sera Prognostics is a leading health diagnostics company focused on improving the lives of women and babies through precision pregnancy care [3] - The company's mission is to provide early, pivotal pregnancy information to enhance maternal and newborn health, ultimately reducing healthcare delivery costs [3] - Sera has a robust pipeline of innovative diagnostic tests aimed at early prediction of preterm birth risk and other pregnancy complications [3] Leadership Appointment - Mr. Lee Anderson has been appointed to a leadership role at Sera Prognostics, bringing extensive experience in the biotechnology and diagnostics sector [1] - Anderson previously held significant positions at Genomic Health and Exact Sciences, where he led US Oncology Sales and Global Customer Service, achieving nine consecutive years of revenue growth [1][2] - His role at Biofidelity Inc. as Chief Commercial Officer further enhanced his commercial strategy expertise and market presence [2] PreTRM® Test - The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test that provides early, accurate, and individualized risk predictions for spontaneous preterm birth in asymptomatic singleton pregnancies [5] - This test analyzes proteins in the blood that are highly predictive of preterm birth, allowing physicians to identify at-risk women between weeks 18 and 20 of pregnancy [5] - The PreTRM® Test enables more informed and personalized clinical decisions based on individual risk assessments [5] Preterm Birth Context - Preterm birth, defined as any birth before 37 weeks' gestation, is the leading cause of illness and death in newborns [4] - Over the last six years, more than one in ten infants in the United States has been born prematurely, leading to significant long-term medical complications [4] - The estimated annual healthcare costs for managing complications related to prematurity in the U.S. were approximately $25 billion in 2016 [4]