ZenTech, your newborn

screening partner
 Our facilities

• Owned by ZenTech since 2001

• Headquarters in the Scientific Park attached to Liège University
• Size: 2.200 m2
 1.200 m2 for Production
 600 m2 for R&D
• ‘5S’ workplace organization methodology
• NBN EN ISO 9001:2015 and 13485:2016
• Compliance with the 98/79/EC European IVD Directive
 Human ressources

• ZenTech has very high standards in terms of the skills required of

its staff
• Vocational training and natural curiosity must be prioritized both
by the company and its employees
 Timeline
2001
ZenTech foundation 2006
Management By Out
(Radim Belgian subsidiary) MBO
Purchase of Gamma
Early Life
2009 Stage
Access to early life stage
product portfolio

2012
Reagents + Alisei 1st Solutions

Breakthrough
2015 ASIA
NBS in Philippines

Partnership 2018
policy

Company Focus Business plan developed

on NBS towards NBS market
technologies only segment
We work for a safer life start for more
newborns in more places!

Therefore we develop, source and provide

highly robust IVD solutions for NBS Dx , by the
means of innovative and cost efficient
technologies; an increasing portfolio; in more
world region; and different customer levels!

We offer an extensive portfolio comprising of

software, reagent and instruments; as
integrated solution or stand alone use;
together with complementary products!
 Our vision
6

« EARLY DIAGNOSIS TO ENSURE

CHILDREN A SAFER LIFE START»
 ZenTech becomes a globally acting and locally
present full range provider of comprehensive
in-vitro diagnostic solutions for Newborn
Screening and related applications for
pregnant women, recent mothers and
ZenTech’s Vision children.

In midterm ZenTech will be recognized as

Champion in NBS!
ZenTech Solutions
 903TM Collection Cards

FDA approved

Neonatal use

Long Expiry date

Tailored cards

Standard cards
BSD Puncher range
Analysis
On Dried Blood Spot
 ELISA and Enzymatic Assays
Type of assay Product Name Disease

Neonatal PKU Phenylketonuria

Neonatal G-6-PD Glucose-6-phosphate dehydrogenase deficiency

Enzymatic Neonatal MSUD Maple syrup urine disease

Neonatal Biotinidase Biotinidase deficiency

Neonatal Total Galactose Galactosemia

Neonatal TSH
Congenital Hypothyroidism
Neonatal T4

ELISA assays Neonatal 17-OHP Congenital adrenal hyperplasia

Neonatal IRT
Cystic fibrosis
Neonatal PAP
 Analyzers
For small and big laboratories

Modular solutions Automated solutions

Small or medium throughput Medium or high throughput

laboratories laboratories
On Dried Blood Spot
 DNA Analysis Mass Spectrometry

Spinal Muscular Atrophy Newborn Screening Hemoglobinopathies Screening

(α-thalassemia, β-thalassemia, Sickle Cell Disease,
compound heterozygote Homozygote HbC, HbE, HbOArab &
HbDPunjab, Healthy carrier of β globin variant)
 ZenTech
The QUALITY first !

Every batch released is tested following

ZenTech quality control requirements

ZenTech s.a. is registered at GMED

 ISO 9001:2015
 ISO 13485:2016

ZenTech participates to the CDC NSQAP

 Device performance follow-up
Participation to External Quality Assessment Surveys

CDC Proficiency Testing (NSQAP)

In 2021, - 4 surveys per year

- 9 devices tested

ZENTECH HAS RfB Proficiency Testing

PARTICIPATED TO - 4 surveys per year
- 4 devices tested

EQA Survey for Neonatal G6PD Screening

- 4 surveys per year
- 1 device tested

UKNEQAS Newborn SickleCellScreening

- 12 surveys per year
- 1 device tested
 Academic and Product
Pragmatic approach improvement

Usability Real user feedback

 ZenTech supports newborn
screening program in Indonesia by
its long-lasting partnership with
Setia Anugrah Medika
Do not hesitate to request further information

m.bellefroid@zentech.be