Flawed Study Design—the Other “Pre-Analytical Variable” in Biomarker Research

Why are we failing to find biomarkers for early detection of disease?  Throughout our blog we write a great deal about biospecimen integrity and emphasize the control of pre-analytical variability in biospecimens. However, the highest quality biospecimens are wasted in the search for biomarkers if the study design is flawed. And the literature on biomarker discovery studies is filled with examples of poor study design, creating an overabundance of false positives that cannot be validated.

Topic: Biobanking and Biorepository, Topic: Labora..........

Gut Bacteria Rivals Immunotherapies in Cancer Treatment

The human gut contains more than 100 trillion bacteria from perhaps 500 or more different species. In fact, gut bacteria outnumber the cells in the human body. The vast number of these bacteria has caused researchers to take a closer look at how they are related to health and disease. Now, breaking scientific research suggests that gut bacteria may be more important than anyone previously realized: they appear to be effective cancer treatments.

Topic: Laboratory Processing, Topic: Cell Therapy ..........

The Link Between Epigenetics and CRISPR-Cas9

When it was first released in 2012, the CRISPR-Cas system stunned scientists with its potential for revolutionizing biological research. Researchers initially noticed that bacterial genomes often contain “clustered regularly interspaced short palindromic repeats,” now dubbed CRISPR sequences. When scientists provide the Cas enzyme with a guide RNA sequence, they can tell it precisely where to slice the DNA. This allows unprecedented control over DNA slicing and insertion of new genetic code.

Topic: Laboratory Processing, Topic: Cell Therapy ..........

The Microbiome of the Skin and Beyond: The MoBE

Our skin is not only our largest organ, and the surface through which we experience the world, it is also a complex ecosystem in its own right. Grice et al (2008)1 estimated that more than a million micro-organisms of more than a hundred distinct species reside on a square centimeter of skin. The recent research into the microbiome of the skin shows that we have not only a great diversity of microorganisms in our skin microbiome, but also a high degree of variation from individual to individual. And although research into the interactions between the skin microbiome and dermal and other disorders is fairly new, it has become clear that the more diverse the microbiome, the healthier the skin.

Topic: Biobanking and Biorepository, Topic: Labora..........

The Evolution of Public Health Research: Sir Austin Bradford Hill and the Cigarette-Rolling Machine

In 1923, a general practitioner in rural Virginia received a phone call from a friend, a surgeon at a hospital in Richmond. A middle-aged man with an uncommon form of cancer had been admitted to the hospital - would he like to come and see the patient, the friend asked. It was a rare opportunity to examine and diagnose an unusual illness first-hand. The country doctor was happy to visit the hospital and further his education, especially since he'd doubted seeing more than one or two similar patients over the rest of his career.

Topic: Biobanking and Biorepository, Topic: Labora..........

CRISPR-Cas9 is Revolutionizing Gene Editing

CRISPR-Cas is a gene editing technology that is revolutionizing the biotech industry. In 2012, two researchers were performing basic research when they inadvertently discovered a gene editing technology that forever changes how scientists edit genes.

Emmanuelle Charpentier and Jennifer A. Doudna were trying to gain a better understanding of the system that bacteria use to defend themselves against viruses. The researchers noticed that bacterial systems could slice out specific sections of DNA with incredible precision. The team then realized that, with the correct programming, the system could also replace a specific section with new DNA – in essence, the bacteria were performing gene editing on their own DNA in a better way than scientists were doing it in the laboratories.

Topic: Laboratory Processing, Topic: Cell Therapy ..........

Avoiding Hemolysis in Blood Sample Collection and Processing

Depending on your point of view, red blood cells, or erythrocytes, are throwaways and a nuisance, ruining a good blood specimen if the cells burst and contaminate the sample. On the other hand, erythrocytes have significant value in specific types of research, and if your objective is biobanking these cells in an intact state, then hemolysis and the need for a re-draw is equally as much to be avoided.

Erythrocyte cell membranes rupture easily, releasing hemoglobin and flooding the sample with potassium and other internal components. Fortunately, breakage of erythrocytes is easy to detect, as the hemoglobin turns the serum or plasma sample from pink to red, depending on the number of cells that have lysed.

Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. How can hemolysis be prevented?

Topic: Biobanking and Biorepository, Topic: Labora..........

Is “Controlling Pre-analytical Variability” an Elusive Target in Biobanking Urine Samples?

The wealth of information in urine samples makes this material critical for research, and for biobanking. The value of this humble waste product is evident from the fact that it is the third most-tested sample in diagnostic laboratories, after serum/plasma profiles and complete blood cell (CBC) counts. However, researchers collecting urine samples for storage and downstream analysis face the same issues as diagnostic laboratories—determining how reliable a test result can be, given the difficulty in controlling  pre-analytical variability.

Topic: Laboratory Processing, Topic: Clinical Tria..........

Liquid Biopsies Used in Personalized Medicine Represent Disruptive Innovation

Time magazine considers liquid biopsies one of the top five investment opportunities of 2015. Investors considering new developments in healthcare like ideas that have the potential to change existing treatment protocols or dramatically impact an entire industry segment. These investors look for “disruptive innovation” or “impact investing” and many are actively engaged in helping bring the new personalized medicine break-through technology to market.

The liquid biopsy is one example of a relatively new idea that has the potential to change the life sciences industry and further scientific discovery. 

In this blog, let's explore the potential benefits of liquid biopsies as a minimally invasive methodology. We'll also consider the challenges associated with the technology and explore how it may impact treatment protocols and strategies.

Topic: Biobanking and Biorepository, Topic: Labora..........

Whole Blood Basics: How to maintain a stable sample

Like any other fluid or tissue sample, whole blood can be most effectively analyzed when its integrity is maintained throughout collection, processing and storage. But how do you maintain the quality of a whole blood sample when considering long term storage? What happens when a sample is not handled properly?

Topic: Biobanking and Biorepository, Topic: Labora..........

Minimizing Your Sample Freeze/Thaw Cycle to Maintain Sample Integrity

Laboratory_Processing_Digram_to_Aliquot_or_NotIn designing clinical studies, much thought is given to controlling for clinical and demographic variability. For example, a well-designed study will carefully enroll patients of a particular disease type, stage, and treatment regimen. In addition, for each of these variables there will be determinations made as to how many patients of what age, sex, and ethnicity should be included in each of the clinical groups. By carefully considering the sample size needed for each variable, clinicians target specific and meaningful data when analyzing the results.

Topic: Laboratory Processing, Content: Blog

[Video] The Journey of a Sample... in the Biobank Laboratory

So much depends on the subtle variations in biospecimens: these variations, when analyzed via genomics, proteomics, metabolomics, and similar studies, are the foundation of both disease-based and drug-based biomarker discovery. And if the unique "-omics" of a sample is to yield results that lead to improvements in medical research and healthcare, such as understanding disease cause/progression (predictive/prognostic biomarker) to PK/PD in clinical trials (surrogate endpoints), then the entire integrity of the specimen must be protected, or biomarker research/study can go astray. 

Content: Video, Topic: Laboratory Processing