Upon news that over the past two months, Massachusetts-based Pressure BioSciences, Inc. (PBIO-OTC) has raised an excess of $2.2 million, and seeks to raise more in February 2014, it is time to look closer at the business of this small-cap company. A quick Google search will tell you that Pressure BioSciences makes laboratory instruments for the “sample preparation” market—a market that is integral to life science research in tens of thousands of laboratories worldwide. But what is sample preparation? Is there a market for Pressure BioSciences’ products?
What is Sample Preparation?
Scientific research has advanced from cellular biology (studying the structure and composition of whole cells) to molecular biology—studying the structure and function of the macromolecules found within cells (e.g., proteins and nucleic acids). Genomics (the study of genes and their function) and proteomics (the study of proteins) are fields of molecular biology. Preparing a sample for scientific analysis, or “sample preparation,” is an important laboratory step for genomic, proteomic, lipidomic, and small molecule studies as well as other areas of life science research. There are two key goals of sample preparation: (1) to remove any interference that may affect the results of the scientific analysis; and (2) to increase abundance of targeted analytes (the substances being measured), thus improving detectability and ultimately the utility of the scientific analysis.
Sample preparation can encompass a wide range of activities, from sampling and collecting to isolating, extracting, and concentrating. Cell lysis—the act of breaking down a cell—is the first laboratory step in this process. A range of tools and techniques are used to break up cells, including instruments known as “bead beaters,” “sonicators,” “homogenizers,” “mortar and pestle grinders,” “French Press,” “freezer milling,” “enzymatic digestion,” and “chemical dissolution.” The process of sample extraction entails separating a substance—such as nucleic acids (DNA, RNA), proteins, and small molecules—from the plant or animal cells and tissues that are being studied. Sample extraction is generally regarded as the key part of sample preparation.
The image below illustrates cell lysis. On the left side in Box 1 is a representation of a whole cell, which can be human, animal, plant, microbial, etc. The cell is composed of thousands of different proteins and contains RNA, DNA, lipids, and small molecules. The outside layer is a membrane called the lipid bilayer, which is composed of opposed layers of lipids containing many intertwined membrane proteins. In order to study the individual components of the cell membrane, it has to be broken up (“lysed”) into smaller pieces and separated. The middle image (“2”) shows the representative cell being broken up. The right side (“3”) is a magnification of a small section of the broken up cell. Once lysed, researchers can study individual components of the cell, such as specific membrane proteins, and further, individual components of proteins and nucleic acids.
Studying proteomics, genomics, and lipidomics within cells can help answer important questions about diagnosis, treatment, and prognosis of many forms of disease and disorders. As an example, differences in membrane proteins from prostate cancer cells may help physicians identify whether aggressive intervention such as a radical prostatectomy is clearly indicated versus whether the patient would have the greatest benefit from avoiding invasive procedures and simply continuing to monitor this typically indolent cancer in a “watchful waiting” mode.
Currently, cancer patients may try a therapy for months before an assessment is completed to ascertain whether the therapy is beneficial. In contrast, tests could be developed to detect for specific proteins or mutations that help select the best therapy for individuals and their specific cancer types, and which monitor treatment response and prognostic outlook. This latter process is called “personalized medicine,” and is often heralded as the treatment paradigm of the future.
Why do we need better technologies for this type of laboratory research?
While technology has vastly improved for analyzing samples, technology for preparing samples prior to their analysis has lagged behind. Sample preparation can be both a complex and time-consuming process. The University of Florida has identified human error as a major concern in sample preparation. Additionally, it is estimated that laboratory professionals spend as much as 80% of their time preparing samples for analysis (Source: Lab Manager Magazine, July 13, 2011). As a result, sample preparation remains the main bottleneck for discoveries in genomic and proteomic research (Source: BCC Research, Sample Preparation in Genomics, Proteomics, and Epigenomics: Global Markets, September 2011). Important cell components may be lost, degraded, damaged, or otherwise adversely affected during the process of breaking up and separating the components of the cell, hindering a scientist’s ability to obtain relevant and meaningful results. If the cellular substructures are not completely broken up, important proteins are inadvertently removed from the sample or otherwise obscured from analysis. If cellular structures are too aggressively broken up, important proteins are reduced to nonfunctional fragments of little or no value for subsequent analysis. Regardless of the advanced technology used to study the sample after it is prepared, important cell components lost or obscured through the sample preparation process will not be found in the analysis of the sample.
To the numbers…Is there a market for laboratory products?
The sample preparation market encompasses products, technologies, and services used to prepare samples for genomics, epigenomics, lipidomics, and proteomics. These products and services are used by academic and government research institutions, biotechnology and pharmaceutical companies, diagnostics manufacturers and clinical laboratories, and other public and private laboratories. Pressure BioSciences estimates that there are over 500,000 researchers and over 80,000 research laboratories working with biological samples worldwide.
The sample preparation market was valued at approximately $4.6 billion in 2012, and was forecast to reach $5.4 billion in 2013. The market is expanding rapidly, with potential to more than double to $11.5 billion by 2018 (Source: BCC Research, Sample Preparation in Genomics, Proteomics, and Epigenomics: Global Markets, September 2013). Growth drivers for this market include increasing R&D investments for drug discovery and new drug development, growing demand for genetically modified crops and organisms, and the emergence of new technologies (Source: Transparency Market Research). The current transformation of healthcare and medical practice from a standardized “one size fits all” model into the new “personalized medicine” paradigm is being driven by a revolution in biomarker discoveries converted into diagnostic tools to inform these treatment guidance decisions and provides a perfect example of such a major emerging technology and market shift.
So, where do Pressure BioSciences’ products fit?
Methods to decrease errors in sample preparation include using automated sample processing devices (to avoid human error), increasing the homogeneity of the raw material under investigation, and decreasing the total elapsed time between sample collection/arrival to when it is evaluated. Pressure BioSciences’ products offer critical improvements and risk mitigation in all three of these dimensions for reducing sample preparation errors. The company uses a patented pressure cycling technology (PCT) platform, which is able to apply and release high levels of hydrostatic pressure in a safe and controlled manner, in order to improve accuracy, quality, and processing time in the laboratory.
Pressure BioSciences believes that its Barocycler® instruments and PCT consumable products fill an important and growing need in the sample preparation market. Based on market dynamics, the company has identified several benefits of commercializing PCT technology for the sample preparation market, as summarized below.
■ The sample preparation market has a large unsatisfied need for better technology solutions.
■ It is composed mostly of research laboratories, which are subject to minimal governmental regulation.
■ It offers many applications with low technical risk for rapid development of the Company’s products.
■ It is compatible with Pressure BioSciences’ technical core competency.
■ The Company has a strong patent and proprietary knowledge position in this area.
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