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Hycor Biomedical bringt das CE-Kennzeichen auf dem IvD-Allergieinstrument NOVEOS™ an
  • USA - English


News provided by

Hycor Biomedical

Jan 04, 2018, 03:00 ET

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GARDEN GROVE, Kalifornien, 4. Januar 2018 /PRNewswire/ -- Hycor Biomedical, ein führender Hersteller von In-vitro-Diagnostikprodukten für Allergie-und Autoimmuntests, gab heute den Erhalt des CE-Kennzeichens für sein Allergietestsystem NOVEOS™ zusammen mit einem anfänglichen Angebot von Gesamt-IgE- und über einhundert spezifischen IgE-Allergenreagenzien bekannt.

NOVEOS bietet mehrere bahnbrechende Eigenschaften, einschließlich:

Hycor Biomedical Applies CE Mark to IVD Allergy Instrument: NOVEOSTM
Hycor Biomedical Applies CE Mark to IVD Allergy Instrument: NOVEOSTM
  • Erfordernis kleinerer Proben: Es werden nur 4µl Volumen von Patientenproben benötigt, was besonders in der pädiatrischen und geriatrischen Probenahme wichtig ist, wo die Entnahme größerer Proben schwieriger sein kann.
  • Echte Walk-Away-Funktionalität: Im Gerät verfügbare Reagenzien bieten ausreichend Kapazität für bis zu 8 Stunden kontinuierliche Tests. Dadurch entfällt das ständige Nachfüllen von Materialien während eines typischen Arbeitstages. Da das System jederzeit bis zu 75 Tests pro spezifischen Allergen und bis zu 140 Allergene erlaubt, ist die Überwachung durch Labortechniker für einen maximalen Zeitraum nicht erforderlich.
  • Verwendung von Standardextrakten: Viele der nicht raffinierten Extrakte, die bei Hautsticheltests und kompetitiven Allergietests verwendet werden, erzeugen aufgrund ihrer Komplexität weniger zuverlässige Patientenergebnisse. Da die Allergenindustrie zunehmend zu höher angereicherten oder standardisierten Extrakten übergeht, integriert das NOVEOS-System diese Materialien und liefert konsistentere und genauere Ergebnisse.

„Wir sind stolz, dass wir NOVEOS auf den EU-Markt bringen", sagte Dr. Fei Li, President und Chief Executive Officer von Hycor. „Diese bahnbrechenden Eigenschaften unterstreichen Hycors Engagement, die Immundiagnostik mit der Verfügbarkeit der ersten neuen, hoch automatisierten Allergieplattformtechnologie in einer Generation in die Zukunft zu bewegen."

„Eine neue Labortestoption für Allergien mit diesen bahnbrechenden Eigenschaften wird von der medizinischen Gemeinschaft sehr begrüßt", sagte Professor Harald Renz, Direktor und Vorsitzender der Labormedizin und Pathobiochemie an der Philipps-Universität, Marburg, Deutschland, und ehemaliger Vorsitzender der Deutschen Gesellschaft für Allergologie und klinische Immunologie. „Konkret hat das Erfordernis kleinerer Probengrößen, die bei 1/10 der heute von den meisten Labors geforderten Probengröße liegen, das Potenzial, die Erfahrung sowohl von pädiatrischen und älteren Patienten als auch von Labors neu zu definieren."

NOVEOS ist Hycors neuestes Allergietestgerät, das auf dem EU-Markt kommt. Hycor wird in Zukunft in den Vereinigten Staaten die 510(k)-Zulassung bei der Food and Drug Administration beantragen.

Über Hycor Biomedical
Hycor wurde 1981 gegründet und ist ein weltweiter Hersteller und Vermarkter von In-vitro‑Diagnostika. Seit seiner Gründung hat Hycor seine Aktivitäten auf Allergie- und Autoimmun-Produkte ausgedehnt, die in klinischen Labors, Krankenhäusern und Arztpraxen weltweit eingesetzt werden. Hycor brachte unlängst NOVEOS™ auf den Markt und erweiterte damit die bestehende Produktlinie des Unternehmens, zu der die Marken HYTEC® und AUTOSTAT® zählen. Das Unternehmen konzentriert sich auf die Bereitstellung von Produkten, die Klinikern den größtmöglichen Wert durch Innovation, Zuverlässigkeit und Kundendienst sichern. Weitere Informationen finden Sie unter www.HYCORbiomedical.com.

Foto - https://mma.prnewswire.com/media/623497/Hycor_Biomedical_NOVEOS.jpg
Logo - https://mma.prnewswire.com/media/623514/Hycor_Biomedical_Logo.jpg

Related Links

http://www.HYCORbiomedical.com

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