Redcliffe Labs' Novel Research: Penta Marker Test Improves Pregnancy Risk Screening with 36% Fewer False Positives

Overview

• Redcliffe Labs' research evaluated Penta Marker screening in 1,159 pregnant women during the first trimester.
• The study found a 36% reduction in false-positive results compared with conventional first-trimester screening.
• Conventional screening classified 17 women as high-risk, compared with 11 women using Penta Marker screening.
• The research also highlighted Penta Marker screening's potential for early identification of pre-eclampsia risk.
• The Penta Marker Test provided results within 3 days, supporting faster clinical decision-making.
• The research was published in the International Journal of Scientific Research.

Redcliffe Labs' Research on Penta Marker Screening

Prenatal screening plays an important role in assessing the risk of chromosomal abnormalities during pregnancy. Conventional first-trimester screening typically combines maternal age, ultrasound assessment of nuchal translucency, and two blood markers, beta-hCG and PAPP-A.

Redcliffe Labs' research evaluated an expanded screening approach by adding three additional biomarkers, AFP, PLGF, and Inhibin-A, to the conventional screening approach.

The research, titled "Advancing Prenatal Care: The Role of Penta Marker in the First Trimester Aneuploidy Screening," examined whether this expanded approach could improve first-trimester pregnancy risk screening.

What Is the Penta Marker Test?

Penta Marker screening combines five maternal serum biomarkers to provide additional information during first-trimester pregnancy risk assessment.

The five markers evaluated in the research were:

• Beta-hCG
• PAPP-A
• AFP (Alpha-Fetoprotein)
• PLGF (Placental Growth Factor)
• Inhibin-A

Researchers evaluated these biomarkers alongside first-trimester ultrasound and relevant maternal factors to assess the risk of chromosomal abnormalities and other pregnancy-related complications.

How Was the Research Conducted?

The study evaluated samples from 1,159 pregnant women undergoing first-trimester screening.

Researchers collected samples between 11 and 13+6 weeks of gestation to assess aneuploidy risk.

The researchers compared conventional first-trimester screening with the expanded Penta Marker approach, which incorporated AFP, PLGF, and Inhibin-A alongside the conventional markers.

The research was conducted at the National Reference Laboratory, Redcliffe Labs, Noida, under the supervision of Dr. Ankur Jindal, Department of Cytogenetics, and Krishan Kumar, Department of Clinical Biochemistry and Special Assays.

What Did the Study Find?

The study found a significant difference in the number of women classified as high-risk when Penta Marker screening was applied.

Conventional Screening

Of the 1,159 pregnant women screened, conventional first-trimester screening classified 17 women as high-risk for genetic abnormalities.

Penta Marker Screening

With the addition of AFP, PLGF, and Inhibin-A, the number of women classified as high-risk decreased to 11.

This represented a 36% reduction in false-positive results compared with conventional screening.

What Does the 36% Reduction Mean?

A screening test estimates the likelihood of a condition; it does not confirm a diagnosis.

A false-positive result can lead to additional testing, anxiety, and referrals for invasive diagnostic procedures. The reduction from 17 high-risk classifications to 11 in the study cohort suggests that the expanded screening approach may help reduce unnecessary high-risk classifications.

Penta Marker Screening and Pre-Eclampsia Risk

The research also highlighted the potential of Penta Marker screening to identify early signs of pre-eclampsia risk.

Pre-eclampsia is a pregnancy complication that can affect the health of both the mother and baby. Identifying increased risk earlier in pregnancy can allow healthcare professionals to consider appropriate preventive measures and monitoring.

The research therefore explored the potential of Penta Marker screening to provide information beyond chromosomal-risk assessment, including pregnancy-related complications such as pre-eclampsia.

Why Does Early Pregnancy Risk Screening Matter?

The first trimester provides an important window for assessing pregnancy-related risks.

Earlier risk assessment can give healthcare professionals more time to:

• Understand the pregnancy risk profile
• Determine whether additional testing is required
• Plan appropriate monitoring
• Discuss findings with the expectant parents
• Consider preventive interventions when clinically appropriate

The purpose of screening is to identify pregnancies that may require further evaluation—not to establish a diagnosis on its own.

How Is Penta Marker Screening Different?

Conventional first-trimester screening uses beta-hCG and PAPP-A, together with ultrasound assessment such as nuchal translucency.

The Penta Marker approach evaluated by Redcliffe Labs adds:

AFP + PLGF + Inhibin-A

This provides a broader panel of maternal serum biomarkers for first-trimester risk assessment.

According to the research, incorporating these additional markers reduced the number of women classified as high-risk in the study cohort.

Faster Results for Earlier Clinical Decisions

Another finding highlighted by the research was the 3-day turnaround time for Penta Marker screening.

Faster availability of screening information can help healthcare professionals make clinical decisions sooner and reduce prolonged waiting associated with additional confirmatory pathways.

The research highlighted this shorter turnaround as one of the potential advantages of the Penta Marker approach in prenatal screening.

Potential to Reduce Unnecessary Invasive Procedures

A high-risk screening result may lead to further diagnostic evaluation.

Reducing false-positive classifications can therefore potentially reduce the number of women referred unnecessarily for invasive procedures such as amniocentesis, which carries a small risk of complications.

The study highlighted the potential of Penta Marker screening to reduce such follow-up procedures by improving risk classification during the first trimester.

What Are the Five Markers?

Beta-hCG

Beta-human chorionic gonadotropin is a pregnancy-related hormone used as one of the serum markers in first-trimester screening.

PAPP-A

Pregnancy-associated plasma protein-A is a maternal serum marker used in first-trimester screening for chromosomal abnormalities.

AFP

Alpha-fetoprotein is a protein produced by the developing fetus and is used as a marker in prenatal screening.

PLGF

Placental growth factor is associated with placental development and vascular function and can provide information relevant to pregnancy-related complications.

Inhibin-A

Inhibin-A is a pregnancy-related hormone that can be incorporated into maternal serum screening algorithms.

Together, these five markers form the Penta Marker panel evaluated in the research.

What Is Aneuploidy Screening?

Aneuploidy refers to an abnormal number of chromosomes.

Prenatal aneuploidy screening assesses the risk of certain chromosomal conditions, including trisomy 21 (Down syndrome).

Screening does not confirm whether a chromosomal condition is present. A high-risk result indicates that further evaluation may be appropriate.

Screening Is Not the Same as Diagnosis

This distinction is important for understanding prenatal screening.

Screening estimates the likelihood or risk of a condition.

Diagnostic testing determines whether a condition is actually present.

Penta Marker screening is therefore a risk-assessment tool. Results should be interpreted by a qualified healthcare professional alongside ultrasound findings, maternal factors, medical history and other relevant clinical information.

A high-risk screening result does not by itself confirm a chromosomal abnormality.

What Could Fewer False Positives Mean for Expecting Parents?

A high-risk screening result can create uncertainty and may lead to additional investigations.

In the study cohort, Penta Marker screening reduced the number of high-risk classifications from 17 to 11.

The researchers reported this as a 36% reduction in false-positive results, indicating the potential of the expanded screening approach to improve risk classification and reduce unnecessary follow-up.

Research Findings at a Glance

Parameter	Finding
Study population	1,159 pregnant women
Screening period	11 to 13+6 weeks of gestation
Conventional high-risk classifications	17
Penta Marker high-risk classifications	11
Reduction in false-positive results	36%
Additional biomarkers	AFP, PLGF, Inhibin-A
Screening focus	First-trimester aneuploidy risk
Additional pregnancy risk highlighted	Pre-eclampsia
Reported turnaround time	3 days

What Does the Research Mean for Prenatal Care?

The research highlights the potential of an expanded first-trimester screening approach that combines conventional markers with AFP, PLGF and Inhibin-A.

In the study cohort, this approach reduced high-risk classifications from 17 to 11 and was associated with a reported 36% reduction in false-positive results.

The findings also highlight the potential role of Penta Marker screening in identifying pregnancy risks earlier and providing results within a shorter timeframe.

Further clinical evaluation should always be based on the individual pregnancy and the advice of the treating healthcare professional.

Research Team

Dr. Ankur Jindal
Department of Cytogenetics, National Reference Laboratory, Redcliffe Labs, Noida

Krishan Kumar
Department of Clinical Biochemistry and Special Assays, National Reference Laboratory, Redcliffe Labs, Noida

Geetanjali Gupta
Redcliffe Labs, Noida

Publication Details

Research Paper: Advancing Prenatal Care: The Role of Penta Marker in the First Trimester Aneuploidy Screening

Journal: International Journal of Scientific Research

Research Area: Prenatal Screening | Aneuploidy Screening | Maternal & Fetal Health

Read the Full Research Paper

Read the published research on the role of Penta Marker screening in first-trimester aneuploidy risk assessment.

Read the Research Paper →