Agi­lent ob­tains ap­proval for GenetiSure Dx Post­nasal As­say

BioSpectrum (India) - - SUPPLIER NEWS -

Agi­lent Tech­nolo­gies Inc. has an­nounced that it has ob­tained 510(k) clear­ance from the US Food and Drug Ad­min­is­tra­tion (FDA) for the GenetiSure Dx Post­na­tal As­say: its first com­par­a­tive ge­nomic hy­bridiza­tion (CGH) as­say for di­ag­nos­tic use. This as­say en­ables clin­i­cal ge­neti­cists to de­tect ge­netic aber­ra­tions as­so­ci­ated with de­vel­op­men­tal de­lay, in­tel­lec­tual dis­abil­i­ties, con­gen­i­tal ir­reg­u­lar­i­ties, and un­ex­plained dys­mor­phic fea­tures, ear­lier and more ac­cu­rately than tra­di­tional meth­ods.

The GenetiSure Dx Post­na­tal As­say is the re­sult of an ex­ten­sive clin­i­cal val­i­da­tion uti­liz­ing 900 sam­ples from mul­ti­ple part­ner lab­o­ra­to­ries and brings CGH tech­nol­ogy into di­ag­nos­tics. Based on Agi­lent's pro­pri­etary ar­ray for com­par­a­tive ge­nomic hy­bridiza­tion, this as­say pro­vides data on copy num­ber vari­a­tions and ab­sence of het­erozy­gos­ity in ge­nomic DNA ob­tained from pe­riph­eral whole blood in pa­tients who have been re­ferred for chro­mo­so­mal test­ing based on clin­i­cal pre­sen­ta­tion. The abil­ity to de­tect both types of aber­ra­tions us­ing a sin­gle as­say pro­vides greater di­ag­nos­tic yield and faster time-to-re­sults.

Pre­vi­ously avail­able only in Europe, US clin­i­cal ge­netic sci­en­tists can now use this as­say to help iden­tify a de­fin­i­tive ge­netic di­ag­no­sis, and rapidly change the fo­cus of a med­i­cal in­ves­ti­ga­tion from find­ing the cause to ad­min­is­ter­ing ap­pro­pri­ate med­i­cal care and fam­ily sup­port.

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