The NMPA Center for Medical Device Evaluation (CMDE) published an article on pediatric In vitro diagnostic (IVD) on October 21, 2024.
According to the definition in Clinical Pediatrics, the scope of pediatrics is primarily divided into the neonatal period (from birth to 28 days), infancy (from birth to 1 year), toddlerhood (1 to 3 years), and childhood (from 3 years up to 18 years and under). In vitro diagnostic (IVD) reagents used broadly in pediatrics are mainly for the detection of genetic diseases in newborns, pediatric-specific diseases, and products used by both children and adults.
Major companies like Abbott, Roche, Danaher, Becton Dickinson, Bio-Rad Laboratories, and bioMérieux have numerous IVD products approved for adult use in China, but only a few have made their way into the pediatric market.
Status of Pediatric IVD Reagents on the Market
Currently, the approved IVD reagents for pediatric use mainly include the following categories:
| Product Category | Examples |
| Ⅲ-1 Reagents related to the detection of pathogenic microorganisms’ antigens, antibodies, and nucleic acids | Group A rotavirus antigen/nucleic acid detection reagents, adenovirus antibody/antigen/nucleic acid detection reagents, enterovirus antibody/nucleic acid detection reagents, norovirus antigen detection reagents, Haemophilus influenzae type B antigen/antibody/nucleic acid detection reagents, etc. |
| Ⅲ-2 Reagents related to blood type and tissue typing | Neonatal ABO and RhD blood type detection cards, etc. |
| Ⅲ-3 Reagents related to human gene testing | SMN1 gene, deafness gene, thalassemia gene detection reagents, etc. |
| Ⅲ-4 Reagents related to genetic diseases | Multiple amino acids, carnitine, succinylacetone detection reagents, phenylalanine detection reagents, neonatal 17a-hydroxyprogesterone detection reagents, etc. |
| Ⅱ-3 Reagents for hormone detection | Neonatal thyroid-stimulating hormone detection reagents, etc. |
Some pediatric IVD reagents are mainly used for the screening of genetic diseases in newborns. For example, alanine detection is used for the screening of hereditary phenylketonuria (PKU), while amino acid, carnitine, and succinylacetone detection reagents are used to screen for inherited metabolic diseases. These metabolic diseases mainly include amino acid metabolism disorders, fatty acid oxidation disorders, and organic acid metabolism disorders.
For diseases prevalent in infants and young children, the expected target population for these IVD reagents is also mostly infants and young children. For example, A group rotavirus antigen/nucleic acid detection reagents, adenovirus antibody/antigen/nucleic acid detection reagents, and norovirus antigen detection reagents are used to diagnose diarrhea in infants. Neonatal ABO and RhD blood type detection cards are used to determine whether neonatal red blood cells are sensitized by incomplete antibodies. The detection of 17α-hydroxyprogesterone is used for the auxiliary diagnosis of congenital adrenal hyperplasia, and glucose-6-phosphate dehydrogenase (G6PD) detection is used for the early diagnosis of congenital metabolic disease caused by G6PD deficiency. The SMN1 exon deletion detection reagent is used for the auxiliary diagnosis of spinal muscular atrophy (SMA).
Shortages in Pediatric IVD Reagents
Clinically, there is a shortage of pediatric IVD reagents, particularly products used to detect rare diseases (e.g., single-gene disorders) and genetic diseases. The main issue is the incomplete coverage of disease types, leaving significant gaps.
Outlook
Considering the biological characteristics, indications, and clinical risks of the pediatric population, there are higher demands on the technical development and validation of pediatric IVD reagents, which also leads to higher R&D costs. Additionally, there are challenges in conducting clinical trials, such as patient recruitment, informed consent, and institutional review board requirements.
Applicants should fully utilize the current preferential policies for pediatric IVD reagents, such as the priority review process outlined in the Priority Review Procedure for Medical Devices, which includes applications “dedicated to children and demonstrating significant clinical advantages.” Attention should also be given to policies related to hospital-developed reagents to better meet pediatric needs.
NMPA review agencies will strengthen communication with applicants during product development and registration to accelerate the launch of pediatric IVD reagents and meet the clinical needs of pediatric patients.