Westlake VitaDx Pioneers Erythrocyte Folate Mass Spectrometry Testing to Support National Goal of Reducing Folate Deficiency in Pregnant Women to Below 5%

Recurrent miscarriage, birth defects, and gestational hypertension are common complex obstetric conditions, most of which have unclear etiologies. In recent years, a substantial body of research has indicated that the intake and supplementation levels of nutrients such as folic acid and niacin are closely associated with the incidence of these disorders.

Internationally, there are hundreds of studies on the relationship between nutritional factors and obstetric diseases. However, due to the lack of precise detection technologies, the conclusions of these studies exhibit high heterogeneity.

Precise detection of folic acid and niacin holds significant public health importance for the prevention of birth defects. Relying on mass spectrometry technology, Westlake Vitae focuses on the detection of B-vitamins in red blood cells and has developedComprehensive Folate Function Test, Comprehensive Niacin Function Test...and other products. Its comprehensive functional assay for folate can simultaneously detect all key molecules associated with folate metabolism in both red blood cells and plasma, providing a holistic assessment of overall folate metabolic function. The test results reflect individual variations, offering robust evidence for clinicians to develop personalized supplementation regimens.

Currently, Westlake Vitae has completed its angel round of financing, led by Hangshi Asset Management and followed by the Westlake University Industry Fund. Recently, VCBeat conducted an exclusive interview with Shi Hongjun, Chairman of Westlake Vitae.

In 2005, Shi Hongjun earned a Bachelor of Biomedical Science degree from Victoria University of Wellington in New Zealand, and in 2012, he obtained a Ph.D. in Pathology from the University of Otago.

From 2012 to 2017, Shi Hongjun conducted postdoctoral research in embryology at the Victor Chang Cardiac Research Institute, affiliated with the University of New South Wales in Australia. His primary research interests focused on the regulatory mechanisms of heart development and the pathogenic mechanisms of congenital heart disease. In late 2017, Shi Hongjun joined the School of Life Sciences at Westlake University as a Distinguished Investigator and Principal Investigator of the Laboratory of Heart Development.

The research group led by Shi Hongjun was the first to discover that niacin deficiency disrupts embryonic energy metabolism, leading to recurrent miscarriage and multi-organ malformations in newborns.This disease was namedCongenital Niacin Deficiency Syndrome. Adequate niacin supplementation during pregnancy can prevent the occurrence of such diseases.

Niacin testing is of significant clinical importance; however, Shi Hongjun has observed that it has long been neglected due to insufficient accuracy of current detection technologies and immature clinical education, resulting in a lack of international gold standards and large-scale population statistical data.

“Later, through extensive discussions with clinicians, we found that not only niacin but also other B vitamins, including folate—which has long been a major focus in clinical practice—suffer from inaccurate detection.” Therefore, after returning to China in 2018, Shi Hongjun dedicated himself to overcomingMass Spectrometry Detection of B Vitamins in Red Blood CellsThis technical challenge.

In 2018, Shi Hongjun established scientific research collaborations with Peking Union Medical College Hospital and other institutions to conduct multi-center studies on recurrent miscarriage. Subsequently, the company partnered with Beijing Obstetrics and Gynecology Hospital to participate in a birth cohort study involving 500,000 participants, focusing on research into B-group vitamins and birth defects.

As mass spectrometry technology for B-vitamin testing gradually matured, Shi Hongjun established Weidu Huimei Medical Laboratory in 2019. In 2020, Weidu Huimei obtained its Medical Institution Practice License. In 2021, Xihu Weitai was founded with the aim of further strengthening research and development capabilities, rapidly and extensively introducing efficient and accurate mass spectrometry-based B-vitamin testing in red blood cells into clinical practice to benefit patients.

B vitamins include folic acid, niacin, and others. Among these, folic acid is an essential substance for cell growth and tissue repair, and it is a crucial nutrient during embryonic development. Since folic acid cannot be synthesized in the body and must be obtained through exogenous intake, thereforeFolic acid supplementation during pregnancy is a crucial measure to reduce the incidence of pregnancy-related complications and prevent birth defects.In 2017, the National Nutrition Plan (2017-2030) proposed thatThe rate of folate deficiency among pregnant women should be controlled to below 5%.. Many regions in China are providing folic acid free of charge to pregnant women.

There is still room for improvement in folic acid supplementation among pregnant women in China. Shi Hongjun stated, “Previously, Westlake Vitae tested 2,000 pregnant women and found that the prevalence of folic acid deficiency among pregnant women in northern China was as high as 70%.” This figure falls significantly short of the target set by the National Nutrition Plan, which aims to keep the rate of folic acid deficiency among pregnant women below 5%.

Serological testing is the commonly used clinical method for folate detection at the current stage.Serological folate testing is relatively mature and offers rapid results; however, due to the fluctuating nature of water-soluble vitamins and their susceptibility to dietary influences, it cannot accurately reflect the body's folate storage levels.To date, there is no universally accepted reference range for normal serum folate levels.

Furthermore, red blood cell folate testing based on chemiluminescence also holds a certain share in clinical practice in China. Synthetic folic acid lacks biological activity in the human body and must undergo multi-step enzymatic reactions to be converted into active folate before it can be utilized by cells; however,Red blood cell folate testing based on chemiluminescence can only measure total folate and cannot distinguish between active and inactive folate,Especially in cases where mutations occur in folate metabolism genes, the ratio of active folate to inactive folate can become significantly skewed, leading to inaccurate test results.

Overall, both serological folate testing and chemiluminescence-based red blood cell folate testing have limited efficacy in preventing birth defects. There is an urgent clinical need for highly efficient and precise folate detection methods to reduce the prevalence of folate deficiency.

To address clinical needs, Westlake Vitae has developed leadingRed Blood Cell Folate Assay Based on Liquid Chromatography-Tandem Mass Spectrometry—Comprehensive Folate Functional Testing. This product is capable ofSimultaneous detection of various intermediate metabolites of folate metabolism, including active folate, and key small-molecule coenzymes in a single small-volume blood sample offers high specificity, rapid turnaround, and more scientific and comprehensive results.

“We have developed a unique pre-treatment formula and an automated liquid handling workstation, which simplifies the pre-treatment process, reduces the operational steps of the kit, and improves work efficiency. Currently, batch sample pre-treatment takes only 40 minutes, and sample detection takes just 3 minutes. We believe that our precise, user-friendly, and cost-effective comprehensive folate function testing products will be widely adopted in clinical practice, contributing to the prevention of birth defects,” said Shi Hongjun.

Shi Hongjun stated, “The accuracy of red blood cell B-vitamin testing has gained widespread recognition,”If costs can be controlled within a more reasonable range, universal screening for red blood cell B-vitamin testing will be achieved.“It can significantly reduce the incidence of birth defects. It is evident that the market for precise testing of B-vitamins in red blood cells within third-party medical laboratories is largely untapped, indicating substantial future potential.”

Taking the complete folate function testing product as an example, it is estimated that if universal screening were conducted for all women who are preparing for pregnancy or are currently pregnant, more than 20 million individuals would require folate testing annually. Based on a terminal price of RMB 400 per test,The annual market size for folic acid testing will reach RMB 8 billion.

Currently, Westlake Vitae has established collaborations with multiple hospitals. “The testing volume for comprehensive folate function assays is expected to exceed 200,000 tests next year.”

Looking ahead, Westlake Vitae will continue to cultivate the market for its mass spectrometry-based assay of B-complex vitamins in red blood cells, apply for medical device registration certificates, and promote the clinical adoption of comprehensive folate function testing products in major hospitals and community health centers. Meanwhile, the company will target the fields of birth defects and prenatal screening, leveraging its mass spectrometry platform to accelerate the R&D of multiple products—including comprehensive niacin function testing, prenatal screening, and prenatal diagnosis—and develop more novel test kits that meet clinical needs.