DM AAA POC Kit: Predicting Premature Birth with Dual Markers
A revolutionary point-of-care kit that uses plasma gelsolin and HCG markers to accurately predict premature birth risk, providing affordable early detection for at-risk mothers.
The Global Burden of Premature Birth
Premature birth is a critical global health issue affecting more than 1 in 10 babies worldwide. According to WHO, approximately 13.4 million babies were born preterm in 2020, with complications being the leading cause of death among children under 5 years of age.
In low-income settings, half of babies born at or below 32 weeks die due to lack of feasible, cost-effective care, while in high-income countries, almost all survive with proper NICU facilities. The burden remains particularly pronounced in regions with low socio-demographic index, covering half of the world's population.
13.4M
Preterm Births
Globally in 2020
900K
Annual Deaths
From preterm complications
50%
Mortality Rate
In low-income countries for babies born ≤32 weeks
India's Premature Birth Crisis
India faces the highest burden of premature birth-related deaths globally. Of the 27 million babies born in India annually, 3.6 million are born prematurely, and approximately 303,600 do not survive due to complications. Nearly half of all child mortality in India is attributed to pre-term births.
Prematurity
48% of newborn deaths
Birth Asphyxia
13% of newborn deaths
Pneumonia
12% of newborn deaths
Non-communicable
7% of newborn deaths
Current Detection Methods and Limitations
Detecting premature birth currently involves clinical assessments, imaging techniques, and laboratory tests, but each method has significant limitations.
Cervical Length Measurement
Transvaginal ultrasound can measure cervical length, but only indicates probability without enabling risk mitigation. Companies developing portable ultrasounds and wearables face sensitivity and specificity issues.
Fetal Fibronectin Test
This invasive method checks for a protein in vaginal secretions but can only be employed 72 hours before labor onset with only 50% accuracy. Initially approved in the USA, it was withdrawn in 2018.
Blood Tests
RNA fragment analysis in maternal blood can predict spontaneous preterm births, but no study has defined how early and accurately this can predict premature birth or whether results can guide medical interventions.
The Role of Plasma Gelsolin and HCG in Pregnancy
Plasma Gelsolin
Plasma gelsolin is a protein that modulates immune response and maintains tissue integrity during pregnancy. It acts as a scavenger of actin released during cell injury, preventing harmful actin filaments that can cause vascular and tissue damage.
Lower levels of plasma gelsolin have been associated with increased risk of preterm birth, as it may indicate an inadequate response to inflammation and tissue injury.
Human Chorionic Gonadotropin (HCG)
HCG is produced by the placenta after implantation and supports the corpus luteum, which produces progesterone during early pregnancy. It promotes fetal development, modulates the maternal immune system, and serves as a key marker for pregnancy detection.
Abnormal HCG levels can indicate potential issues such as ectopic pregnancy, miscarriage, or trophoblastic disease, making it valuable for monitoring pregnancy health.
Ashish Lab Data:
Key Findings on GSN and HCG
First Trimester
Plasma HCG increases rapidly; if it doesn't increase, gelsolin remains low, potentially leading to early abortion.
Second Trimester
HCG levels start to decrease while gelsolin levels increase. If HCG doesn't decrease, gelsolin doesn't increase, potentially leading to premature birth.
Third Trimester
Gelsolin should increase further; if it doesn't increase by 1-2 fold from prior values, mothers may have extended recovery time after birth.
Post-Delivery
Gelsolin increases further right after delivery, aiding in maternal recovery from the birthing process.
Our Solution: The DM AAA POC Kit
Step 1: Confirm Pregnancy
First confirm pregnancy by HCG in urine using our semi-quantitative kit that provides high, low, or medium level estimation rather than just yes/no answers.
Step 2: Monitor HCG Levels
For patients with prior history of premature birth or in risk zones, use our kit twice: once for pregnancy confirmation and again after 2-3 months to confirm HCG levels are decreasing, indicating healthy pregnancy progression.
Step 3: Second Trimester Check
Around the 13th week, confirm decrease in HCG value and increase in gelsolin value simultaneously, indicating healthy pregnancy progression.
Step 4: Third Trimester Verification
Around 32nd-34th week, test again to ensure increased levels of gelsolin, which predicts better maternal recovery after birth.
Target Market and Next Steps
Our primary target users include IVF cases, mothers with known premature birth history, late-age conceptions, risky pregnancies, and mothers with pre-conception hormonal issues.
Stakeholder Meeting
Online meeting and approach discussion
Funding
Seed fund and venture estimation
Development
Prototype for clinical trials
Market Launch
Finalization and marketing