Apostle Lab是美国Gritstone（纳斯达克股票代码：GRTS）的临床实验室系统解决方案提供商之一。2022年，由Gritstone 牵头，美国哥伦比亚大学医学院、梅奥诊所、纪念斯隆凯特琳医疗中心、MD Anderson等机构参与的一项I期临床试验发表于Nature Medicine 杂志。标题“Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results.”该临床试验评价了Gritstone mRNA癌症疫苗用于晚期转移性实体瘤患者的安全性和有效性，并观察到较长OS的患者有较低的循环肿瘤DNA水平。
Apostle Lab是美国NIH（美国国立卫生研究院）牵头的一项I期临床试验的临床实验室系统解决方案提供商之一。2022年，由NIH牵头，麻省总医院、杜克大学医学院等机构参与的一项I期临床试验发表于Nature Medicine 杂志。标题“Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial.”该临床试验评价了AAV8-VRC07对于HIV患者CD4细胞、病毒载量的临床效果。Apostle 作为临床实验室技术提供商之一参与。
[I期临床试验 Phase I Study] Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results
"Exploratory biomarker analyses showed decreased circulating tumor DNA (ctDNA) in patients with prolonged OS... cfDNA was extracted from the entire plasma volume of a single draw using the Apostle MiniMax cfDNA Isolation kit (ApostleBio) "
- A phase I clinical study published in Nature Medicine by a joint clinical team from Gritstone, Columbia University Medical Center, Mayo Clinic, MSKCC, MD Anderson, etc.
[I期临床试验 Phase I Study] Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial
"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."
- A phase I clinical study published in Nature Medicine by NIH, Medical University of South Carolina, MIT and Harvard, Caltech, Duke, Vaxart, and ModeX
Simultaneous analysis of mutations and methylations in circulating cell-free DNA for hepatocellular carcinoma detection
"The model detected four of the five HCC cases in the cohort, showing 80% sensitivity and 94% specificity. These findings demonstrate that the MCP technology has potential for the discovery and validation of multiomics biomarkers for the noninvasive detection of cancer. This study also provides a comprehensive database of genetic and epigenetic alterations in the cfDNA of a large cohort of HCC cases and high-risk non-HCC individuals." "cfDNA was extracted from the plasma samples using the Apostle MiniMax cfDNA isolation kit (C43468, Apostle). "
"Plasma cell-free DNA (cfDNA) from 2821 myeloid or lymphoid neoplasm patients were collected. cfDNA was sequenced using a 275 gene panel... This data shows that liquid biopsy using targeted NGS is reliable in detecting chromosomal structural abnormalities in myeloid neoplasms...Overall, this study supports the use of liquid biopsy for early diagnosis and monitoring of patients with myeloid neoplasms...We extracted cfDNA from 2821 peripheral blood samples using the Apostle MiniMax High Efficiency cfDNA Isolation Kit (San Jose, CA). "
- A clinical study published in Frontiers in Oncology by Hackensack University Medical Center, Ernest Mario School of Pharmacy at Rutgers University, Englewood Health Internal Medicine Residency Program, and Genomic Testing Cooperative
"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. "
"...Elucidating the relationship between these pathways and the increased circulating mitochondrial DNA observed here will provide further insight into the cell-damaging effects of prolonged inhalation of e-cigarette aerosols. " "For measurement of in vivo plasma mtDNA/nDNA ratio, mice plasma was first subjected to cell-free DNA (cfDNA) extraction using Apostle minimax cfDNA extraction kit (ApostleBio, CA, US). "
"Therefore, wastewater monitoring for SARS-CoV-2 variants in the community is a feasible strategy as a complementary tool to clinical specimen testing in the latter's absence. " "The NP swabs received at the Nevada State Public Health Laboratory (NSPHL) from the Reno-Sparks metropolitan for SARS-CoV-2 diagnostic testing were subjected for RNA extraction using Virus Total NA Isolation Fast Kit (Apostle MiniGenomics, San Jose, CA, USA)"
- An independent clinical study published in Scientific Reports by Nevada State Public Health Laboratory
With Apostle automation, my team and I have been able to develop a method to detect and quantify SARS-CoV-2 in wastewater samples, while also having the ability to sequence viral RNA from the wastewater samples. ...Apostle was able to quickly supply us with instruments, plates and reagents for a fraction of the price of the competitors. Apostle has been a great partner for us. Their technical support team programmed our MagTouch 2000 at no cost, and their team was supportive and accommodating every step of the way.
- Lauryn Massic, Association of Public Health Laboratories infectious disease fellow at the Nevada State Public Health Laboratory. (Read Interview)
"An instance of sequential infection of an individual with, firstly, the Delta variant and secondly a Delta-sub-lineage has been identified. The individual was found positive for the AY.26 lineage 22 days after being found positive for the Delta [B.1.617.2] variant...Nucleic acid extractions were performed by Apostle MagTouch Nucleic Acid Extraction Automation Systems [Apostle Inc, San Jose, CA]. "
"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). "
- A clinical study published in EBioMedicine from Peking Union Medical College, Sun Yat-sen University Cancer Center, Jinchenjunchuang Clinical Laboratory, China
Apostle COVID-19 RNA Extraction System is a fast and reliable solution for SARS-CoV-2 viral RNA extraction. We look forward to continuing the collaboration with Apostle and providing high quality COVID-19 tests for our community.
- Harry Gao, MD, PhD, DABMG, FACMG, Lab Director and Chief Scientific Officer, Fulgent Genetics (Nasdaq: FLGT)
"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). "
- A clinical 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. )
美国联邦政府 CLIA 临床实验室执照
ISO 9001 证书
ISO 13485 证书
Apostle Lab在美国加州旧金山湾区Pleasanton拥有超过16,000平方英呎的自有总部建筑和场地。包括临床实验室、研发实验室、办公区、仓储。总部大楼地址为：3589 Nevada St, Pleasanton, CA 94566。Pleasanton普莱森顿位于美国旧金山湾区，距离硅谷中心地带（Apostle San Jose 圣荷西实验室所在地）大约30分钟左右车程，是加州旧金山湾区生命科技企业，尤其是诊断和医疗器械企业的主要集聚地之一。Apostle 的总部大楼占地约一英亩，距离 Roche 罗氏诊断普莱森顿园区、美国ThermoFisher 赛默飞世尔科技普莱森顿园区、美国Bio-Rad 伯乐生命医学普莱森顿园区等著名生命科技企业均在5英里半径内。
Apostle Lab在美国加州硅谷中心地带 San Jose 圣荷西市运作有4000余平呎的临床实验室场地。地址为：160 E Tasman Dr, STE 116, San Jose, CA 95134。
Apostle Lab在美国加州旧金山机场Burlingame市运作有2000余平呎的临床实验室场地。地址为：1818 Gilbreth Rd, STE 127, Burlingame, CA 94010。