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  首頁 > 美迪醫(yī)訊 > Agendia公司乳腺癌轉(zhuǎn)移危險的檢查方法獲得ISO認(rèn)證  

Agendia公司乳腺癌轉(zhuǎn)移危險的檢查方法獲得ISO認(rèn)證

【?2005-09-21 發(fā)布?】 美迪醫(yī)訊
美迪網(wǎng)領(lǐng)先的醫(yī)療器械電子商務(wù)平臺


 
一種以微陣列(基因芯片)為基礎(chǔ)的診斷檢查評估了乳腺癌患者腫瘤轉(zhuǎn)移的危險。

這種檢測方法叫做MammaPrint,在荷蘭Agendia的實(shí)驗室中進(jìn)行了操作。這項檢測使用了70個基因?qū)⑷橄侔┻M(jìn)行分類:在10年內(nèi)出現(xiàn)遠(yuǎn)處腫瘤轉(zhuǎn)移的低危和高危人群。Agendia的此項服務(wù)已經(jīng)獲得了ISO認(rèn)證。

MammaPrint為腫瘤科醫(yī)生和乳腺癌患者提供了有關(guān)疾病后續(xù)治療有價值的信息,這或許包括對可能出現(xiàn)遠(yuǎn)處轉(zhuǎn)移的患者進(jìn)行化療。在歐洲和美國幾個醫(yī)學(xué)中心進(jìn)行臨床研究已經(jīng)證實(shí),MammPrint比傳統(tǒng)的分類方法更加優(yōu)越,例如當(dāng)前廣泛使用的St. Gallen標(biāo)準(zhǔn)。MammaPrint能夠精確鑒別出那些傳統(tǒng)方法認(rèn)為無需治療的患者,并避免化療的嚴(yán)重副作用。

Agendia是一家生物技術(shù)公司,是荷蘭癌癥研究院的讓產(chǎn)易股公司,在晚期癌癥研究方面具有堅實(shí)基礎(chǔ)。ISO是一種對檢測實(shí)驗室能力進(jìn)行認(rèn)證的國際標(biāo)準(zhǔn)。這種認(rèn)證授予為期4年,在此期間,荷蘭認(rèn)證委員會將對該公司的實(shí)驗室進(jìn)行年檢,以確保該公司能夠達(dá)到ISO的所有要求。

Risk Test for Breast Cancer Metastasis
 
A microarray-based diagnostic test assesses the risk of metastasis in breast cancer patients.

Called MammaPrint, the test is administered in the laboratory facilities of Agendia (Amsterdam, The Netherlands). The test uses a 70-gene profile to classify breast cancer patients as having low or high risk of developing distant metastases in a 10-year period. Agendia has received ISO accreditation for the service.

MammaPrint offers valuable information to oncologists and breast cancer patients concerning the subsequent treatment of their disease, which may include chemotherapy for patients at risk of developing metastases. Several studies in medical centers in Europe and the United States have demonstrated that MammaPrint outperforms conventional classifying methods such as the widely used St. Gallen criteria. MammaPrint accurately identifies patients who can be left untreated when evaluated by conventional methods, sparing them the serious side effects of chemotherapy.

Agendia is a biotechnology company that is a spin-off of The Netherlands Cancer Institute and has a strong base in advanced cancer research. ISO is an international standard for the competence of testing laboratories. The accreditation is granted for four years, during which the Dutch Accreditation Council will perform yearly inspections of the company’s laboratory facilities to confirm that the company is conforming to all ISO requirements.

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