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Apostle MiniMax Technology


For research use only. Not for use in diagnostic procedures.

Overview

The ability to isolate and analyze circulating cell free DNA (cfDNA) at very low concentrations is becoming increasingly important, particularly in non-invasive prenatal test (NIPT), early cancer detection, and infectious disease diagnosis. Highly efficient isolation of cfDNA from complexed biological medium is a crucial step for subsequent cfDNA analysis. 

Apostle MiniMaxTM technology offers a best-in-class efficiency and purity compared with conventional technologies to capture and isolate the circulating cell-free genetic materials.

Performance Assessment

Apostle MiniMax technology offers a best-in-class efficiency and purity compared with conventional technologies to capture and isolate the circulating cell-free genetic materials. It has been trusted by many of the world's most prestigious leaders in life sciences.

"...This includes recognizing that an innovative product from Apostle is the best technology to address these needs." said Steve Wowk, Director of Genomics, Beckman Coulter Life Sciences.


Some Examples of Published Performance Assessment Data


(Figure 4) - "Most notably, the Apostle particles outperformed all others, achieving almost 2-fold higher recovery yields than the particles supplied in the X kit. "

This link directs to an external page, reviewing the performance and data of Apostle MiniMax by Beckman Coulter Life Sciences.

(Figure 1) "For each tube the Apostle MiniMax extracted higher total yield of DNA. "


This link directs to an external Application Note. This application note compares workflows and yield for the extraction of cfDNA using Apostle MiniMax High Efficiency cfDNA Isolation Kit, following the manual protocol, automating the extraction using the Biomek i7 Hybrid Workstation, and semi-automating the extraction using the KingFisher Duo Prime Sample Purification System.

This link directs to an external Application Note. This application note compares workflows and yield for the extraction of cfDNA using Apostle MiniMax High Efficiency cfDNA Isolation Kit, following the manual protocol, automating the extraction using the Biomek i7 Hybrid Workstation, and semi-automating the extraction using the KingFisher Duo Prime Sample Purification System.

This link directs to an external poster presented at ASHG 2019. This poster presents the data associated with correlation between mutations found In FFPE tumor tissue and paired cfDNA samples.

This link directs to an external poster presented at ASHG 2019. This poster presents the data associated with the comparison between mutation profiles of paired whole blood and cfDNA samples.

This link directs to an external poster presented at AACR 2019. This poster presents a comparison of matched FFPE and plasma samples to determine how many mutations are seen in both tissues.

This link directs to an external poster presented at AGBT 2019. This poster presents a novel cfDNA extraction kit and show its compatibility with extractions from 200 µl – 5 mL.


Applications

Apostle MiniMax technology has been applied in world-class research and development projects of novel liquid biopsy technologies.  Some examples include: 

Multiplex assays, involving the simultaneous use of multiple circulating tumor DNA (ctDNA) markers, can improve the performance of liquid biopsies so that they are highly predictive of cancer recurrence. We have developed a single-tube methylation-specific quantitative PCR assay (mqMSP) that uses 10 different methylation markers and is capable of quantitative analysis of plasma samples with as little as 0.05% tumor DNA. In a cohort of 179 plasma samples from colorectal cancer (CRC) patients, adenoma patients, and healthy controls, the sensitivity and specificity of the mqMSP assay were 84.9% and 83.3%, respectively. In a head-to-head comparative study, the mqMSP assay also performed better for detecting early-stage (stage I and II) and premalignant polyps than a published SEPT9 assay. In an independent longitudinal cohort of 182 plasma samples (preoperative, postoperative, and follow-up) from 82 CRC patients, the mqMSP assay detected ctDNA in 73 (89.0%) of the preoperative plasma samples. Postoperative detection of ctDNA (within 2 wk of surgery) identified 11 of the 20 recurrence patients and was associated with poorer recurrence-free survival (hazard ratio, 4.20; P = 0.0005). With subsequent longitudinal monitoring, 14 patients (70%) had detectable ctDNA before recurrence, with a median lead time of 8.0 mo earlier than seen with radiologic imaging. The mqMSP assay is cost-effective and easily implementable for routine clinical monitoring of CRC recurrence, which can lead to better patient management after surgery. 

We developed a computational program whereby available SD regions can be processed and analyzed efficiently for their potential use as biomarkers of the aneuploidy of interest. For the five common aneuploidies, i.e., trisomy 13, 18, 21, and two sex chromosome aneuploidies, a total of 21,772 candidate SD biomarker sequences together with their corresponding primer/probe sets were generated. The primer/probe sets were tested using a real-time PCR-based multicolour melting curve analysis for simultaneous detection of the five common aneuploidies, and yielded 100% clinical sensitivity and 99.64% specificity when subjected to a clinical evaluation. Following the observations that the SD biomarkers for aneuploidy could be better detected by digital PCR with improved accuracy, we established a noninvasive prenatal testing protocol for trisomy 21 and attained 100% concordance with next generation sequencing.

Our study confirmed that SD regions are preferred biomarkers for aneuploidy detection and in particular SD-based digital PCR could find potential use for NIPT of trisomy. A similar strategy can be applied to other chromosomal abnormality and genetic disorders.

Uniqueness

Apostle MiniMax technology ensures precise capture and separation of circulating genetic materials for liquid biopsy analysis. This is achieved through Apostle’s novel proprietary MiniMax magnetic nanoparticles (Exhibit 2-8) with innovative features:

  • Novel material composition and surface chemistry - completely distinct from the conventional paramagnetic or superparamagnetic technologies
  • Exceptionally large surface area
  • Minimized variation
  • Best-in-class suspension property
  • Superb magnetic power
  • Superb resistance to particle clustering

Significance

A recent paper published in JAMA Oncology by Torga & Pienta revealed that, strikingly, 2 major commercial liquid biopsy tests show significant and clinically unacceptable discordance. 

Why do liquid biopsy tests differ so significantly? Are they reliable? 

Among other impact factors, the extraction method of circulating free DNA (cfDNA) plays a major role here. Data show that different cfDNA extraction methods yield significantly different amounts of cfDNA by 10% to 10 folds, and consequently result in discordant conclusions. When we study genomic DNA isolated from the nucleus of cells, this level of difference may not matter much – because the amount of genetic material commonly reaches hundreds of micrograms (ug), so the downstream testing methods have enough genetic material to work with anyway. However, when we study cfDNA, this level of difference may result in a fundamental discordance, because the amount of cfDNA is commonly less than 100 nanograms (ng). Slight difference of cfDNA yields may result in critical impact on the testable copies of cancer mutations and the signal-to-noise ratio. 

We illustrate how the accuracy of a liquid biopsy is impacted by the cfDNA sample preparation in a figure below. To have a reliable liquid biopsy testing, a highly efficient cfDNA extraction must be achieved.

Exhibit 1. Sample preparation is a critical yet unaddressed challenge in liquid biopsy.

Exhibit 2. Apostle’s proprietary MiniMax magnetic nanoparticles under scanning electron microscope.

The Apostle MiniMax nanoparticles have an increased magnetic strength and a decreased particle size compared to other leading technologies in the market, which ensures excellent suspension in solution and rapid mobility. The optimized surface chemistry allows efficient enrichment of genetic materials from complex biological materials.

Exhibit 3. Apostle’s proprietary MiniMax nanoparticles have uniform sizes.

Apostle’s MiniMax magnetic nanoparticles generated from our proprietary technology have a uniform size distribution with minimized doublets, distinct from the particles from five current technological providers showing random sizes and significant doublets. Highly consistent size distribution of Apostle’s nanoparticles ensure reproducible results.

Exhibit 4. The Apostle MiniMax nanoparticles have a best-in-class suspension property.

Excellent suspension is one of the critical properties of nanoparticles to excel in cfDNA isolation. In this simple but quite visual experiment, we compare Apostle MiniMax with the nanoparticles from other two technologies on the market. The three tubes contain equal weight of different types of nanoparticles. By 1 minute, the other technology #2 is almost completely sedimented. By 15 minute, the other technology #1 is almost completely sedimented. However, Apostle MiniMax has kept the suspension status, showing a superb suspension property.  


https://www.youtube.com/watch?v=ym63t4oLnkQ

Exhibit 5. The Apostle MiniMax nanoparticles have a best-in-class magnetic power.

A strong magnetic power is another critical property of nanoparticles to achieve a good cfDNA isolation performance. In this simple experiment, we compare the magnatic power of Apostle MiniMax with the nanoparticles from other two technologies on the market. The three tubes contain equal weight of different types of nanoparticles. A magnetic plate slowly approaches the three tubes at equal distances. Whichever tube having the strongest magnetic power makes the first move. 
The tube containing Apostle MiniMax makes the first move, while the other two technologies stay still. Apostle MiniMax shows a superb magnetic power.

https://www.youtube.com/watch?v=6SDVUoYzD9Y

Exhibit 6. The Apostle MiniMax nanoparticles have a superb resistance to particle clustering.

The unwanted clustering of particles reduces the performance of the cfDNA isolation, and sometimes even interferes with the normal lab procedures. In this experiment, we compare MiniMax's ability to resist clustering with another leading technology on the market. After adding isopropyl alcohol, the other technology shows particle clustering visible to naked eye, while Apostle MiniMax does not. The Apostle MiniMax nanoparticles show a superb resistance to particle clustering. 

Large Image

What our community say

(Figure 4) "Most notably, the Apostle particles outperformed all others, achieving almost 2-fold higher recovery yields than the particles supplied in the X kit".
- An independent study by scientists at Johns Hopkins University and University of Pittsburgh (read article)
"In this study, we administered a recombinant bicistronic adeno-associated virus (AAV8) vector coding for both the light and heavy chains of the potent broadly neutralizing HIV-1 antibody VRC07 (AAV8-VRC07) to eight adults living with HIV... Plasma AAV8-VRC07 plasmid DNA was measured by extracting DNA from plasma,... DNA was extracted from serum using an Apostle MiniMax High Efficiency cfDNA Isolation Kit, following the manufacturer’s protocol with slight modification."
- An independent study by NIH, Medical University of South Carolina, MIT and Harvard, Caltech, Duke, Vaxart, and ModeX (read article)
(Figure 1) "For each tube the Apostle MiniMax extracted higher total yield of DNA".
- An independent study by scientists at Beckman Coulter Life Sciences (read data sheet)
"The combination of mutation profiling and CNA profiling can improve the detection of MRD, which may help optimize the treatment strategies for patients with locally advanced rectal cancer (LARC)...cfDNA was extracted from 1.5-4.5 mL of plasma with the Apostle MiniMax cfDNA isolation kit (C40605, Apostle; San Jose, CA, USA). "
- An independent study published in EBioMedicine from Peking Union Medical College, Sun Yat-sen University Cancer Center, Jinchenjunchuang Clinical Laboratory, China
"...This includes recognizing that an innovative product from Apostle is the best technology to address these needs."
- Steve Wowk, Director of Genomics, Beckman Coulter Life Sciences
"The mqMSP assay is cost-effective and easily implementable for routine clinical monitoring of CRC recurrence, which can lead to better patient management after surgery... Plasma DNA extraction was performed using 2 to 5 mL of plasma with the Apostle MiniMax High-Efficiency cfDNA Isolation Kit, according to the product manual. "
- An independent study published in PNAS from Department of Gastroenterology, The First Affiliated Hospital of Wenzhou Medical University, China
"Our study confirmed that SD regions are preferred biomarkers for aneuploidy detection and in particular SD-based digital PCR could find potential use for NIPT of trisomy... The cfDNA was isolated from 1 mL of each plasma sample by the Apostle MiniMax™ High Efficiency cfDNA Isolation Kit (Apostle Inc, San Jose, CA). "
- An independent study published in EBioMedicine from State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, Xiamen University, China
"BGI Genomics announces that its Stool Sample Collection Kit, DNA Isolation Kit together with Sample Pretreatment Kit for Methylation Detection have been CE marked. " (Note by Apostle: Apostle is the Original Equipment Manufacturer or OEM for the Stool DNA Isolation Kit mentioned in this news. )
- BGI

Other Information

Apostle also partners with Beckman Coulter to offer the Apostle MiniMaxTM High Efficiency Isolation Kit. If you wish to order the kit through Beckman Coulter, please visit Beckman Coulter's website:

Apostle image 
https://www.beckman.com/reagents/genomic/dna-isolation/from-plasma

For more information about this partnership: https://www.beckman.com/news/liquid-biopsy-partnership-with-apostle

ProductsCat#
Apostle MiniMaxTM High Efficiency Cell-Free DNA Isolation Kit (Standard Edition) (1mL X 10 preps)A17622-10
Apostle MiniMaxTM High Efficiency Cell-Free DNA Isolation Kit (Standard Edition) (1mL X 50 preps)A17622-50
Apostle MiniMaxTM High Efficiency Cell-Free DNA Isolation Kit (Standard Edition) (5mL X 50 preps)A17622-250
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About Us
A recent independent study conducted by scientists from Johns Hopkins University and University of Pittsburgh, published in a peer-reviewed journal SLAS Technology, demonstrated that, "(Figure 4) Most notably, the Apostle particles outperformed all others, achieving almost 2-fold higher recovery yields than the particles supplied in the X kit". Read the article