NEWSCEN IVD Solutions bring together infectious disease diagnostics, clinical health testing and reproductive health self-testing for the European and international markets. Our portfolio includes an IVDR HIV test, HCV testing moving toward IVDR certification, and CE-marked IVDD self-tests for SF, FOB, LH, FSH and HCG.
NEWSCEN IVD Solutions for a Changing European Diagnostic Market
The European in vitro diagnostic (IVD) market is entering a new stage of regulatory and technological development.
With the implementation of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), manufacturers and market partners face higher expectations for product performance, technical documentation, conformity assessment, clinical evidence and post-market surveillance.
For NEWSCEN, this evolving environment represents an opportunity to strengthen our capabilities and develop a broader portfolio of reliable diagnostic solutions.
Today, NEWSCEN IVD solutions cover multiple diagnostic categories:
- HIV — IVDR
- HCV — IVDR certification in progress
- SF — CE-marked IVDD self-test
- FOB — CE-marked IVDD self-test
- LH — CE-marked IVDD self-test
- FSH — CE-marked IVDD self-test
- HCG — CE-marked IVDD self-test
Together, these products form an expanding portfolio designed for the needs of European distributors, healthcare partners and international IVD markets.
What Makes NEWSCEN IVD Solutions Different?
NEWSCEN focuses on developing and supplying diagnostic products across several important testing categories rather than concentrating on only one product segment.
Our portfolio combines:
Infectious Disease Testing
HIV and HCV
Clinical Health Testing
Serum Ferritin and Fecal Occult Blood
Reproductive Health Testing
LH, FSH and HCG
This product diversity gives distributors and international partners greater flexibility when developing their IVD portfolios.
Instead of sourcing individual products from multiple suppliers, partners can explore a broader range of diagnostic solutions through the NEWSCEN brand.
HIV Test — NEWSCEN’s IVDR Diagnostic Solution
The NEWSCEN HIV test is an important product within our European infectious disease diagnostic portfolio and has achieved IVDR status.
The transition from IVDD to IVDR has significantly changed the regulatory landscape for IVD manufacturers in Europe.
The IVDR framework places greater emphasis on:
- Risk classification
- Performance evaluation
- Scientific and clinical evidence
- Technical documentation
- Conformity assessment
- Post-market surveillance
- Product traceability
For NEWSCEN, achieving IVDR status for the HIV product represents an important milestone in our European IVD strategy.
It also reflects our continued focus on regulatory development and product quality.
NEWSCEN HIV Test
Regulatory Status: IVDR
Category: Infectious Disease Diagnostics
HCV Test — Moving Toward IVDR Certification
HCV is another key product within the NEWSCEN infectious disease portfolio.
The NEWSCEN HCV test is currently progressing toward IVDR certification, demonstrating our continued commitment to meeting the evolving requirements of the European IVD market.
The transition toward IVDR requires manufacturers to strengthen their approach to product performance, technical documentation, regulatory compliance and post-market responsibilities.
For NEWSCEN, HCV represents an important next step in the development of our IVDR-oriented product portfolio.
NEWSCEN HCV Test
Regulatory Status: IVDR certification in progress
Category: Infectious Disease Diagnostics
SF Self-Test — Serum Ferritin Testing
The NEWSCEN SF Self-Test is a CE-marked IVDD self-testing product designed for serum ferritin testing.
Ferritin is an important biomarker associated with the body’s iron stores. Ferritin testing can therefore be an important component of health-related testing and assessment.
The SF self-test expands the NEWSCEN portfolio beyond infectious disease diagnostics and into clinical health-related self-testing.
NEWSCEN SF Self-Test
Category: Serum Ferritin
Regulatory Status: CE-marked IVDD self-test
Product Positioning: Self-testing solution
FOB Self-Test — Fecal Occult Blood Testing
The NEWSCEN FOB Self-Test is a CE-marked IVDD self-testing product within the gastrointestinal health testing category.
Fecal occult blood testing is an established testing category associated with gastrointestinal health assessment.
By adding FOB to its portfolio, NEWSCEN provides partners with another self-testing solution within the broader health diagnostic market.
NEWSCEN FOB Self-Test
Category: Fecal Occult Blood
Regulatory Status: CE-marked IVDD self-test
Product Positioning: Self-testing solution
LH Self-Test — Reproductive Health Testing
The NEWSCEN LH Self-Test is a CE-marked IVDD self-testing product designed for luteinizing hormone testing.
LH testing is closely associated with reproductive health and fertility-related testing.
The LH product forms part of NEWSCEN’s broader reproductive health portfolio, together with FSH and HCG.
NEWSCEN LH Self-Test
Category: Reproductive Health
Regulatory Status: CE-marked IVDD self-test
Product Positioning: Self-testing solution
FSH Self-Test — Supporting Reproductive Health Testing
The NEWSCEN FSH Self-Test is another CE-marked IVDD self-testing product within our reproductive health portfolio.
Follicle-stimulating hormone plays an important role in reproductive physiology, making FSH testing an important category within reproductive health diagnostics.
Combined with LH and HCG, the FSH self-test helps create a more complete reproductive health product portfolio.
NEWSCEN FSH Self-Test
Category: Reproductive Health
Regulatory Status: CE-marked IVDD self-test
Product Positioning: Self-testing solution
HCG Self-Test — Pregnancy Testing Solution
The NEWSCEN HCG Self-Test is a CE-marked IVDD self-testing product for pregnancy-related testing.
HCG is a well-established biomarker associated with pregnancy testing, making HCG an important component of the NEWSCEN reproductive health portfolio.
Together with LH and FSH, the HCG product provides NEWSCEN with a broader range of reproductive health self-testing solutions.
NEWSCEN HCG Self-Test
Category: Pregnancy & Reproductive Health
Regulatory Status: CE-marked IVDD self-test
Product Positioning: Self-testing solution
NEWSCEN European IVD Product Portfolio
The following table provides an overview of the current NEWSCEN European product portfolio:
| Product | Diagnostic Category | Regulatory Position |
|---|---|---|
| HIV Test | Infectious Disease | IVDR |
| HCV Test | Infectious Disease | IVDR Certification in Progress |
| SF Self-Test | Serum Ferritin | CE-Marked IVDD Self-Test |
| FOB Self-Test | Fecal Occult Blood | CE-Marked IVDD Self-Test |
| LH Self-Test | Reproductive Health | CE-Marked IVDD Self-Test |
| FSH Self-Test | Reproductive Health | CE-Marked IVDD Self-Test |
| HCG Self-Test | Pregnancy / Reproductive Health | CE-Marked IVDD Self-Test |
This portfolio demonstrates NEWSCEN’s strategy of combining established self-testing products with an increasingly IVDR-oriented diagnostic portfolio.
From IVDD to IVDR: NEWSCEN’s European Regulatory Journey
The European IVD regulatory environment has undergone a major transformation.
IVDR has introduced a more comprehensive regulatory framework intended to strengthen the safety, performance and oversight of IVD medical devices.
For manufacturers, this means that regulatory compliance must be considered throughout the product lifecycle.
NEWSCEN is responding to this changing environment by strengthening its regulatory capabilities and continuing to develop products for international markets.
Our portfolio reflects different stages of this journey:
CE-marked IVDD self-testing portfolio →IVDR HCV transition →IVDR HIV
This progression represents an important part of the NEWSCEN brand strategy for Europe.
A Diverse IVD Portfolio for European Partners
For distributors and IVD companies, product diversity can create additional opportunities for market development.
NEWSCEN’s portfolio provides products across three major areas:
Infectious Disease
HIV | HCV
Clinical Health
SF | FOB
Reproductive Health
LH | FSH | HCG
This combination allows NEWSCEN to support partners looking for multiple diagnostic product categories from a single manufacturer.
Whether the focus is infectious disease diagnostics, clinical health testing or reproductive health self-testing, NEWSCEN continues to expand its portfolio to meet changing market needs.
Why Partner with NEWSCEN?
Choosing an IVD manufacturer is a long-term decision.
NEWSCEN aims to build partnerships around five key principles:
1. Product Diversity
A growing portfolio covering infectious disease, clinical health and reproductive health testing.
2. European Market Focus
A clear commitment to developing products and regulatory capabilities for the European IVD market.
3. Regulatory Development
Continuous progress toward meeting the evolving requirements of the European regulatory environment.
4. International Cooperation
Supporting distributors, healthcare partners and IVD companies in international market development.
5. Long-Term Growth
Building a sustainable product portfolio rather than focusing only on individual products.
NEWSCEN — Your IVD Partner for Europe
The future of IVD is moving toward higher standards for quality, evidence, regulatory compliance and product performance.
NEWSCEN is building its product portfolio with this future in mind.
From our IVDR HIV test to our HCV product progressing toward IVDR certification, and from our established CE-marked IVDD self-tests for SF, FOB, LH, FSH and HCG, NEWSCEN is developing a diversified portfolio for the European and international diagnostic markets.
Our goal is straightforward:
To provide reliable diagnostic products and build long-term partnerships with customers around the world.
Discover NEWSCEN IVD Solutions
If you are an IVD distributor, medical device company, laboratory partner or healthcare organization looking for diagnostic products for the European or international market, NEWSCEN welcomes opportunities for cooperation.
NEWSCEN
Reliable Diagnostics. Expanding Possibilities.
For product specifications, intended use, regulatory documentation, certificates and market availability, please contact NEWSCEN for the latest official information.
Email: export@newscen.com
