PT  - JOURNAL ARTICLE
AU  - Robert H. Lee
AU  - Carl P. Weiner
TI  - Robust cost efficacy of a novel, validated screening test at 12–20 ​Weeks gestation for the prediction of preterm birth (PTB) at or before 32 ​Weeks in singletons
AID  - 10.1016/j.gocm.2021.07.001
DP  - 2021 Sep 01
TA  - Gynecology and Obstetrics Clinical Medicine
PG  - 107--111
VI  - 1
IP  - 3
4099  - http://gocm.bmj.com/content/1/3/107.short
4100  - http://gocm.bmj.com/content/1/3/107.full
SO  - gocm2021 Sep 01; 1
AB  - Objective Preterm birth (PTB) at or before 32 weeks complicates up to 2 ​% of United States (US) births and accounts for 80 ​% of perinatal expenditures in the first year of life. Existing screening tests for PTB performed from 12 weeks to 19 weeks 5 days have receiver operated area under the curve (AUC) indices of <80 ​% and at most <70 ​%. We evaluated FutureBIRTH™, a unique maternal screening test comprised of plasma cell-free RNA for the prediction of PTB ≦ 32 weeks due to spontaneous labor (sPTB) with or without preterm premature rupture of the membranes (PPROM) or early-onset pre-eclampsia before 34 weeks (EOP). FutureBIRTH™ is supported by multiple validation studies derived from 12 weeks to 19 weeks 5 days gestation achieving AUCs of 84.2 ​% for sPTB and 94.1 ​% for EOP.Methods Using the US rates for EOP (0.5 ​%) and sPTB ​≦ ​32 weeks (1.8 ​%) and adjusting the US pregnancy/neonatal medical costs to US dollars (2017 value), we calculated the cost per 100,000 singletons with or without universal FutureBIRTH™ testing before 19 weeks and 6 days using three detection rates and assuming screen-positive women would be treated with and respond to aspirin (assumed 80 ​% efficacy for EOP) and vaginal progesterone (assumed 38 ​% efficacy for sPTB). We also assessed test performance at disease incidence rates below that of the US (down to 0.46 ​%). For considering screening costs, we assumed test costs of $750, and treatment costs of $1000 for patients over 20 weeks gestational age.Results The identification and treatment of ‘at-risk’ pregnancies by FutureBIRTH™ with existing therapies would reduce direct healthcare costs by up to $95 million per 100,000 births. The projected savings were robust and achievable at each FutureBIRTH™ price despite the conservative costs, efficacy, and detection rate assumptions. The incidence of PTB ≦ 32 weeks would decline by 40 %–50 ​% with a test cost of $750 and an 80 ​% detection rate.Conclusion The accurate risk assessment provided by universal FutureBIRTH™ screening coupled with existing preventative treatments could lead to a 40 %–50 ​% decrease in PTB ≦ 32 weeks due to sPTB and EOP among ‘at-risk’ pregnancies, covering the cost of screening and treatment while still saving $450-$950 per pregnancy.FutureBIRTH is a unique test based on the maternal plasma transcriptome.It was invented by Dr Yafeng Dong and Carl Weiner and is the only validated plasma transcriptome based medical test to date.It is also the only test validated for use from 11 to 19 weeks to the predict which women are destined to suffer PTB due either to preterm labor ​± ​PPROM <33w or from early onset preeclampsia.The submitted manuscript suggests universal screening can be cost effected and reduce the rate of PTB<33w by 40–50 ​% using current therapies.