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Harmony

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(NIPT)
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Il più validato

Il test Harmony è il test di screening prenatale basato
su DNA libero circolante (cell-free DNA) più validato.

Opzioni:
• Trisomie 21, 18, e 13
• Aneuploidie dei Cromosomi
Sessuali (SCA)
• Monosomia X
• Sesso del Feto
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Opzioni:
• Trisomie 21, 18, e 13
• Aneuploidie dei Cromosomi
Sessuali (SCA)
• Monosomia X
• Sesso del Feto
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Per ogni donna, di qualsiasi
categoria di rischio, ovunque

Il test Harmony può essere effettuato
in gravidanze singole, gemellari e medicalmente
assistite (IVF), incluse quelle da ovodonazione
eterologa ed è stato validato per l’utilizzo
in donne di qualsiasi età e categoria di rischio.
Harmony è già stata utilizzato per lo screening
di oltre 1milione di gravidanze in più di 100 paesi
in tutto il mondo.
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Risultati affidabili
per tutte le condizioni
testate

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Harmony prenatal test ha mostrato performance
consistenti e affidabili in tutti gli studi clinici
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Cell-free DNA analysis for Non-invasive
Examination of Trisomy (NEXT) Study

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Evidenze Cliniche

Il test Harmony, come test di screening
di prima linea, è supportato da consistenti
evidenze cliniche.

DISEGNO DELLO STUDIO NEXT

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• Intervallo età materna: da 18 a 48 anni (media: 31 anni)
• Intervallo periodo gestazionale: da 10.0 a 14.3 settimane
(media: 12.5 settimane)

Tutte le donne arruolate in questo studio sono state sottoposte
sia allo screening del primo trimestre (FTS) che al test Harmony.
L’esito della gravidanza è stato valutato per ogni caso mediante test
genetico o esame del neonato.
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Performance significativamente superiori

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Nel più grande studio prospettico in cieco del suo tipo,
il test Harmony ha mostrato performance significativamente
superiori rispetto allo screening del primo trimestre (FTS†)
per la trisomia 21 sia per la sensibilità che per il tasso
di falsi positivi.
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RISULTATI DELLO STUDIO NEXT

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La chiarezza è ad un semplice passo

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Ecco perchè è importante avere le risposte appropriate
al momento giusto. Con il test Harmony, i risultati sono chiari
e accurati in modo che anche le risposte da dare lo siano.
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QUESTIONE DI FIDUCIA

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MIGLIORI PERFORMANCE
per ridurre al minimo l’ansia e le procedure
invasive dovute a un risultato di falso positivo.

EVIDENZE SENZA PARI
come dimostrato in studi con oltre 148,000 donne
in più di 48 pubblicazioni peer-review su riviste
indicizzate.

RISULTATI SICURI
il test Harmony fornisce un risultato solo quando
c’è sufficiente quantità di DNA libero circolante
di origine fetale al fine di ottenere un’analisi
accurata.
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Il nostro impegno per la salute

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INFORMAZIONI E SUPPORTO
Il test Harmony è stato sviluppato con la convinzione che tutte le donne
devono avere accesso alla migliore informazione circa la loro gravidanza.
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PORTALE – Traccia facilmente i risultati
e i record, in modo da fornire alla donna
le risposte che servono e quando servono.

ATTIVITÀ EDUCAZIONALI – Siamo impegnati
a sviluppare risorse per aiutare le donne
a capirne di più in merito alla loro gravidanza,
ai risultati del test e molto altro.
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MARKET ACCESS – Il nostro team lavora a livello
del sistema sanitario per fornire le evidenze
cliniche necessarie a consentire l’accesso al test
per la popolazione.

TEST DI SCREENING DI PRIMA LINEA – Il test
Harmony consente uno screening prenatale
di migliore qualità per tutte le donne,
indipendentemente dall’età e fattori di rischio.
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SOCIETÀ
SCIENTIFICHE

NIPT come test di screening
di prima linea per la trisomia 21.

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L’American College of Obstetricians
and Gynecologists (ACOG) e la Society
for Maternal-Fetal Medicine (SMFM)
raccomandano di offrire un test di screening
per le aneuploidie, incluso uno screening
basato su cfDNA, a tutte le donne
in gravidanza.

“ Tutti i laboratori dovrebbero
includere in modo chiaro
la frazione fetale sul referto
… [e] stabilire la validazione
clinica della frazione fetale…
– ACMG Statement 20168 ”
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E’ stato ampiamente dimostrato
che il test Harmony fornisce
una misura altamente accurata
e riproducibile della frazione fetale.

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CONTATTACI

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per maggiori informazioni.

tel. +39 0972 37071
email labotekdiagnostics@gmail.com

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