snapi
snapi is an investigational microbiome-based program for identifying women at elevated risk of preterm birth in early pregnancy. A microbiome matrix has been established in a Korean cohort, and Saem Research is designing a clinical study in Australia to extend the dataset across additional ethnic populations.
A category open for redefinition
Current preterm-risk screening relies on cervical length ultrasound (sensitivity ~38% at the ≤25mm cutoff, Kuusela 2020), and the last commercially available rapid fFN biomarker test was discontinued in September 2024.
A $1.7B obstetric biomarker market (2025), projected to reach $2.5B by 2031 — without a standard product. The first validated workflow becomes the new clinical default.
Hologic Rapid fFN was the standard preterm-risk biomarker for ~25 years.
Hologic discontinues global sales of the Rapid fFN® 10Q cassette — leaving no commercially available rapid fFN point-of-care test.
Saem Research is advancing R&D on two products to fill this gap.
Sources: WHO Preterm birth fact sheet (updated 2024); Kuusela et al., BJOG, 2021; ESS Application April 2026.
A maternal-microbiome read for preterm-birth risk
snapi reads a focused vaginal-microbiome panel and integrates it with a locked machine-learning prediction model — returning a composite PTB risk score in hours, on standard hospital qPCR equipment, without new capital expenditure.
Clinician-collected vaginal swab during the standard prenatal exam at weeks 16–24. No new device. No blood draw.
Targeted multiplex qPCR panel on existing hospital qPCR equipment. No central-lab dependency.
Composite PTB risk score returned within four hours on standard hospital qPCR.
Risk band informs clinical interventions: monitoring cadence, progesterone supplementation, cervical cerclage, and referral.
Existing PTB workflows are symptoms-driven. Risk is identified only once contractions, cervical change, or other clinical signs appear — typically too late for non-emergency intervention. snapi reads PTB risk from the maternal microbiome at week 16–24, before any clinical sign. The OB-GYN gains weeks of clinical runway to plan monitoring, progesterone, or cerclage.
Validated. Locked. Externally tested across two years.
snapi's prediction model achieves AUROC 0.80 on an external temporal hold-out cohort (two years post training-set lock). TRIPOD+AI Type 3 framework. The algorithm and the decision threshold are both pre-locked at training; updates are governed by a Predetermined Change Control Plan (FDA GMLP-aligned). +0.150 AUROC over cervical length screening — externally validated, two years apart.
A regulatory-grade cohort: Korea training + external temporal hold-out cohorts, two-year gap between training-set lock and external validation.
Built around a single longitudinal cohort
PTB Prediction is snapi's first product — externally validated and entering clinical trials. The platform is being designed so the same enrolled mother contributes to two additional diagnostic products as her pregnancy and her baby's first months unfold.
- Current · Preterm birth prediction. Vaginal microbiome qPCR + locked machine-learning prediction model. Externally validated. MFDS pathway in flight.
- Next · Breast Milk Quality Score (BMQS). ELISA + qPCR for sIgA, lactoferrin, and selenium in breast milk. In R&D.
- Later · Infant gut health. Bifidobacterium and commensal markers from meconium and infant stool, tracked over 0–24 months. In development.
Platform vision: one enrolment. Five sample types — vaginal, maternal gut, meconium, breast milk, infant stool. One longitudinal cohort. One Master IRB. Each future product inherits the prior product's data.
The data, the workflow, and the algorithm
Reproducing this asset requires a paired mother-infant longitudinal microbiome cohort, a locked predictive model, and an MFDS-aligned regulatory pathway. None of these can be shortcut with capital alone.
- Patents — assay + locked model. Priority date secured. Patent applications filed covering the assay design and the locked predictive model.
- Cohort asset — cannot be retrospectively collected. A regulatory-grade longitudinal mother-infant cohort. Time, not capital — capital cannot shortcut it.
- Regulatory — MFDS as APAC keystone. Hong Kong · Australia · UK · China. MFDS pathway as the keystone for an APAC cascade.
- Modality — no new device, no new lab. Vaginal swab on installed hospital qPCR infrastructure. No new device, no central-lab dependency.
Built on peer-reviewed research
The vaginal microbiome's role in preterm-birth risk is established science. snapi translates this body of evidence into a clinically validated diagnostic.
Foundational evidence that vaginal microbiome composition in early-to-mid pregnancy is an independent predictor of preterm-birth risk.
Study from Ewha Womans University — snapi's clinical partner — demonstrating feasibility of qPCR + machine learning prediction (10-bacteria panel, sensitivity 71%).
Cervical length ≤25mm predicted spontaneous preterm birth at <33 weeks with sensitivity 38.5% — the current clinical benchmark snapi is positioned to improve.
Additional reading: Callahan et al., PNAS 2017 (independent cohort replication); Kindinger et al., BMC Medicine 2017 (microbiome × cervical length × progesterone); Ravel et al., PNAS 2011 (vaginal community state types).