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White Papers and Videos

A Real-Time-Assay for the fast and gel-free detection of Rhesus Weak D Type 1/1.1 to Type 3

White Paper

In emergency situations, molecular typing of the Rhesus blood group can be helpful but is considered a complicated and slow procedure. This poster shares details from a study that demonstrates reliable and quick real-time PCR typing for weak D types 1, 2 and 3 for a wide range of DNA concentrations.

Fast Real-Time PCR Detection of HLA-B*27 Directly from Blood Using a Specialized Stabilizing Reagent

White Paper

Whole blood or buffy coat is the most commonly used sample material in diagnostic procedures, but often negatively effects PCR applications. In this study we show the tremendous stabilizing effect of a reagent called Blood Booster on direct real-time amplification from fresh blood samples in the FastQ B*27 kit.

Is Your Clinical Diagnostics Contract Manufacturer Prepared to Weather Supply Chain Challenges?

White Paper

Supply chain security and transparency is a key part of the risk mitigation strategy of companies manufacturing clinical diagnostic assays. Prior to the COVID-19 crisis, complex global supply chains carefully balanced capacity with demand, while cost-cutting initiatives pushed towards lower-cost raw material providers located in different geographies.

COVID-19-driven regional manufacturing shutdowns, surge demands, and logistics disruptions have placed significant pressure on clinical diagnostic supply chains, resulting in raw material shortages and delays.

Vetting a Contract Manufacturing Partner for Your Clinical Diagnostics Kit

White Paper

Choosing a contract manufacturing (CM) partner for your clinical diagnostics kit is high on the list of business-critical decisions made during the commercialization process. Outsourcing manufacturing is a valid strategic decision due to the significant capital expenditure required for in-house manufacturing. In addition to the costs of equipment, there is also the need to develop a Quality Management System (QMS) aligned with the required regulatory requirements, the hiring of personnel, and the acquisition of the appropriate certifications.

Due to the significant capital expenditure required, many companies choose outsourcing in order to redeploy their capital towards growing their business and developing new products. Your CM partner should have excellence in supply-chain management, extensive experience in transitioning assays to production, navigating changing international regulatory requirements, and solid QMS and documentation systems.

The Human Gene Mutation Database: Empowering a Generation of Geneticists for Precision Medicine

Video

The Human Gene Mutation Database (HGMD) is a manually curated, comprehensive collection of disease-causing, germline mutations. Since 1996, a team of experts has manually catalogued over a quarter of a million mutations for the database.  

This talk will feature a retrospective view of HGMD, how it has grown over time, and the research that it has enabled. In particular, our speakers will talk about how HGMD has helped move precision medicine forward by providing translational research and diagnostic applications with the most comprehensive survey of literature on genetic mutations responsible for human inherited diseases, supporting standardized interpretation for germline diseases. 

2 Tools for Overcoming Your Clinical Lab’s Toughest Quality Control Challenges

White Paper

Whatever practices you use for NGS assay development, validation, and performance monitoring, your goal is the same: Your results must be as accurate, precise, and consistent as possible.

That goal is within reach. And in this paper, we’ll show you how. By reading this white paper, you will learn:

· Why quality control is so challenging for NGS labs

· How reference materials may be the key to quality control

· The 9 key characteristics of sufficient NGS reference materials

· How to use QC metrics to monitor the health of your NGS assays

· 7 QC data management must-haves