AptoDetectTM-Lung|東京未来スタイルは研究用試薬の輸入商社です。

【Japan Exclusive】

About Aptsci

Aptamer Sciences Inc. is a privately held biotech company focused on commercializing cutting-edge technologies for analysis of proteins, based on its proprietary aptamer technology platforms.
Aptamer Sciences is dedicated to develop the aptamer technologies to generate high quality aptamer and in broad applications of research, diagnosis and therapeutics. In addition to conventional aptamer generating technologies, Aptamer Sciences has developed advanced aptamer technologies and thus can generate aptamers more efficiently with superior binding affinity. Aptamer Sciences has ongoing collaboration relationships with several industry partners. The Company also has research collaboration with several universities, hospitals and research organizations.

（Aptomer Sciences’ website is here）

 

 

Aptamer-based IVD Kit for Lung Cancer Early Detection

With technological advances in genomic and proteomic analysis and development of multiplex assay platforms have made it possible to analyze a large number of biomarkers and to use their information collectively to assist in clinical decision making.

The advantages of multi-biomarker assay in comparison to a single biomarker assay are based on the premise that the single-valued index, with its aggregated information from complementary biomarkers, will outperform each of its component biomarkers used individually.

Since OVA1 clearance in 2009, a number of IVDMIA tests have been used in clinical applications.
Some of these tests have sought regulatory approval/clearance, whereas others have been offered as a laboratory-developed test (LDT).

Aptsci’s initial tests are for lung cancer patients. Future products may address other cancer diseases such as pancreatic cancer, and diabetic retinopathy.

 

Aptsci Lung Cancer Test: a multi-protein biomarker test

Aptsci’s Lung Cancer Test addresses the most common cancer in the world, which affects an estimated 2 million people. It is a blood-based test aimed at decreasing the high rate of false positives from low-dose (spiral) computed tomography (LDCT).

Lung cancer is the leading cause of cancer death and the second most diagnosed cancer in both men and women in the United States. Because lung cancer is usually detected in its later stages, more than 80% of patients die within 2 years of diagnosis. Early and accurate detection, followed with frequent monitoring and responsive therapeutic adjustments, is critical to improving clinical outcomes.
Aptsci’s test is designed to help physicians accurately diagnose this form of cancer, and catch it in earlier stages.

The current standard-of-care diagnostic has a very high error rate. Heavy smokers are recommended to undergo low-dose spiral CT (LDCT) scans annually. A landmark study showed that about 25% of patients that undergo LDCT are thought to have lung cancer, however, more than 96% of those positive scans are “false positives” which result in additional testing that is costly and potentially harmful to patients. Aptsci’s test may be used to confirm LDCT scans, reducing the need for additional diagnostic work ups.

 

200 Korean sample test showed much better performance than old standard (Cyfra 21-1)

We discovered biomarkers that discriminate NSCLC from benign lung diseases and healthy controls, trained a multi-biomarker classifier of NSCLC to meet prespecified performance criteria, and verified the performance of this classifier in a separate set of blinded samples.

The results from these diagnostic case-control studies were compared with Cyfra 21-1, and evaluated for the ability to enhance the diagnostic accuracy of lung nodules detected on CT.

As a result, we developed a 7-protein panel (EGFR1, MMP7, CA6, KIT, CRP, C9, and SERPINA3) in the Korean population to discriminates NSCLC from controls (benign nodules) with 91.7% specificity and 75.0% sensitivity (Clinical Lung Cancer 2016). The AUC of the classifier for lung cancer was 0.88, whereas Cyfra 21-1 had an AUC of 0.72.

 

 

Overview

●Intended use

– Early diagnosis of NSCLC (Non-Small Cell Lung Cancer)

●KFDA approval (Class Ⅲ, 2017. 9)

– IVD reagents for tumor marker, immunology test

●Packaging : 48 or 96 tests/kit

●Specimen : Serum

●Features

– Non-invasive blood test

– 1st  Approved aptamer based IVD

– Multi-variate index assay (7 Biomarkers)
– Sensitivity/Specificity: 75.0%/91.7%

– Results are reported as 0~10 score levels (cut-off value: 5)

 

Product list

Product Name	Model No.
AptoDetectTM-Lung	ALUC-1048 (48-well kit)
	ALUC-1096 (96-well kit)

 

 

About Aptsci

Aptamer Sciences Inc. is a privately held biotech company focused on commercializing cutting-edge technologies for analysis of proteins, based on its proprietary aptamer technology platforms.
Aptamer Sciences is dedicated to develop the aptamer technologies to generate high quality aptamer and in broad applications of research, diagnosis and therapeutics. In addition to conventional aptamer generating technologies, Aptamer Sciences has developed advanced aptamer technologies and thus can generate aptamers more efficiently with superior binding affinity. Aptamer Sciences has ongoing collaboration relationships with several industry partners. The Company also has research collaboration with several universities, hospitals and research organizations.

（Aptamer Sciences’ website is here）

 

 

Aptamer-based IVD Kit for Lung Cancer Early Detection

With technological advances in genomic and proteomic analysis and development of multiplex assay platforms have made it possible to analyze a large number of biomarkers and to use their information collectively to assist in clinical decision making.

The advantages of multi-biomarker assay in comparison to a single biomarker assay are based on the premise that the single-valued index, with its aggregated information from complementary biomarkers, will outperform each of its component biomarkers used individually.

Since OVA1 clearance in 2009, a number of IVDMIA tests have been used in clinical applications.
Some of these tests have sought regulatory approval/clearance, whereas others have been offered as a laboratory-developed test (LDT).

Aptsci’s initial tests are for lung cancer patients. Future products may address other cancer diseases such as pancreatic cancer, and diabetic retinopathy.

 

Aptsci Lung Cancer Test: a multi-protein biomarker test

Aptsci’s Lung Cancer Test addresses the most common cancer in the world, which affects an estimated 2 million people. It is a blood-based test aimed at decreasing the high rate of false positives from low-dose (spiral) computed tomography (LDCT).

Lung cancer is the leading cause of cancer death and the second most diagnosed cancer in both men and women in the United States. Because lung cancer is usually detected in its later stages, more than 80% of patients die within 2 years of diagnosis. Early and accurate detection, followed with frequent monitoring and responsive therapeutic adjustments, is critical to improving clinical outcomes.
Aptsci’s test is designed to help physicians accurately diagnose this form of cancer, and catch it in earlier stages.

The current standard-of-care diagnostic has a very high error rate. Heavy smokers are recommended to undergo low-dose spiral CT (LDCT) scans annually. A landmark study showed that about 25% of patients that undergo LDCT are thought to have lung cancer, however, more than 96% of those positive scans are “false positives” which result in additional testing that is costly and potentially harmful to patients. Aptsci’s test may be used to confirm LDCT scans, reducing the need for additional diagnostic work ups.

 

200 Korean sample test showed much better performance than old standard (Cyfra 21-1)

We discovered biomarkers that discriminate NSCLC from benign lung diseases and healthy controls, trained a multi-biomarker classifier of NSCLC to meet prespecified performance criteria, and verified the performance of this classifier in a separate set of blinded samples.

The results from these diagnostic case-control studies were compared with Cyfra 21-1, and evaluated for the ability to enhance the diagnostic accuracy of lung nodules detected on CT.

As a result, we developed a 7-protein panel (EGFR1, MMP7, CA6, KIT, CRP, C9, and SERPINA3) in the Korean population to discriminates NSCLC from controls (benign nodules) with 91.7% specificity and 75.0% sensitivity (Clinical Lung Cancer 2016). The AUC of the classifier for lung cancer was 0.88, whereas Cyfra 21-1 had an AUC of 0.72.

 

 

Overview

●Intended use

– Early diagnosis of NSCLC (Non-Small Cell Lung Cancer)

●KFDA approval (Class Ⅲ, 2017. 9)

– IVD reagents for tumor marker, immunology test

●Packaging : 48 or 96 tests/kit

●Specimen : Serum

●Features

– Non-invasive blood test

– 1st  Approved aptamer based IVD

– Multi-variate index assay (7 Biomarkers)
– Sensitivity/Specificity: 75.0%/91.7%

– Results are reported as 0~10 score levels (cut-off value: 5)

 

Product list

Product Name	Model No.
AptoDetectTM-Lung	ALUC-1048 (48-well kit)
	ALUC-1096 (96-well kit)

 

 

Aptamer Sciences社（韓国）は、同社のアプタマー技術プラットフォームに基づくタンパク質分析の最新技術を製品化しています。同社は高品質アプタマーを製造するためのアプタマー技術の向上に従事し、その技術・製品は基礎研究、診断、治療など様々な分野で使用されています。一般的なアプタマー製造技術に加え、同社では先進的なアプタマー製造技術を開発し、結合能の優れたアプタマーを効率的に合成しています。同社では、多くの企業、大学、病院等と共同研究を行っております。

(Aptamer Sciences社のウェブサイトはこちら)

アプタマー技術を用いた肺がん早期診断キット

AptoDetect^TM-Lungはアプタマー技術を用いた肺がん早期診断キットです。

近年の遺伝子解析とタンパク解析の技術的進歩はめざましいものがあります。特にマルチプレックスアッセイ装置の登場により数多くのバイオマーカーの解析が可能になり、得られた情報は臨床診断における判断材料として集約的に活用できるようになりました。

卵巣ガンの診断マーカーであるOVA1が2009年にFDAで承認されて以来、数多くのin vitro diagnostic multi variate index assay (IVDMIA)検査が臨床で行われてきました。これらの検査は臨床試験の承認を受けて行われたものもあれば、自家調整検査法(LDT)として検査室内で行われるものもありました。

Aptomer Sciences社は当肺がん検査キットに加え、将来的には膵ガン、その他のガン疾患や糖尿病網膜症などを対象にした製品の開発も検討されています。

Aptsci肺ガン検査：マルチタンパクバイオマーカー検査

肺ガンは全世界で最も罹患者の多いガンであり、その有病者数は約200万人に上るとされています。当社の製品はその肺ガン検査の一つである低線量CT(LDCT)における高い偽陽性率を解決するために開発された血液学的検査マーカーです。

米国において肺ガンは主なガンの中で最も死亡率が高く、男女ともに2番目に診断の多いガンです。肺ガンは既にかなり進行した状態で見つかる場合が多く、8割以上の患者が診断後2年以内に亡くなってしまいます。早期発見と正確な病原部位の特定、そして病状の注意深いモニタリングと病状に応じた治療が、臨床成績や予後を大きく左右します。当キットは早期のステージで正確に肺がんを検出する目的で設計されています。

現在、ヘビースモーカーの人々は毎年LDCTを受けることが推奨されています。しかし、現行の検査法は偽陽性率がとても高いことが分かっています。ある研究ではLDCTを受けた人のうち25％が肺ガン陽性と判定されたものの、そのうち96％が偽陽性だったという結果が出ています。偽陽性の人々に対するさらなる検査はコストがかかるうえに、侵襲的なものもあり、患者への負担も大きくなります。当社の製品をLDCTと併用することにより、LDCTのデメリットをカバーできる可能性があります。

Aptamer Sciences社では、非小細胞肺癌（NSCLC）を肺良性疾患および健常コントロールと区別する複数のバイオマーカーを発見し、多数のサンプルを用いて検証を行いました。この検証結果をCyfra 21-1の結果と比較し、これらのバイオマーカーを用いることにより、肺がんCTのおける診断の正確性を向上することが可能であることが分かりました。

最終的に、7種類のタンパク質で構成される製品が開発されました（EGFR1, MMP7, CA6, KIT, CRP, C9, SERPINA3）。韓国内での試験において、その特異性は91.7%、感度は75.0%でした。Aptamer Sciences社製品のAUCは0.88であり、Cyfra 21-1検査の0.72より優れています。

製品の概要

用途：　NSCLC（非小細胞肺がん）の早期検出

容量：　４８テストおよび９６テスト

サンプル：　血清

特徴

・非侵襲性の血液検査
・アプタマー技術を用いた検査キット
・Multi-variate index assay (7種のバイオマーカー)
・感度/特異性＝75.0%/91.7%
・結果は0～１０のスコアレベルで出力
・試験研究用キット（RUO）

製品リスト

製品名	カタログ番号
AptoDetectTM-Lung	ALUC-1048 (48-well kit)
	ALUC-1096 (96-well kit)

 

※本製品は試験研究用試薬です。診断およびその他の用途ではご使用になれません。