Genome Editing in IVD? Potential Found in New Study

ROCKVILLE, Md., May 31, 2017 /PRNewswire-USNewswire/ -- A new research article demonstrates potential for CRISPR gene-editing in in vitro diagnostics in a particular area of cancer and infectious disease testing. In the past few years, CRISPR technology has emerged as a revolutionary technology that is changing life science research and has the potential to dramatically change medicine. CRISPR (clustered regularly interspaced short palindromic repeats) are DNA sequences that have a key role in a bacterial defense system, functioning as an immune system that protects bacteria and other microorganisms against viruses. CRISPR is utilized in genome editing, the process of modifying the DNA of a particular organism, by introducing breaks at specific, targeted locations in the genome Until recently, these applications did not include diagnostics, according to Kalorama Information. The healthcare market research publisher said that drug development was the largest application field. This is changing, with developments last month.

Kalorama Information's report, Gene Editing Markets (CRISPR-based, Zinc Finger Nuclease [ZFN], TALEN, Other) - Reagents & Tools, Services, Cell Lines, Models, found $382 million dollar market for the technologies, and growth could reach $2 billion in 5 years according to Kalorama's report.

"Estimates in the past for gene-editing have been based on these applications," said Bruce Carlson, Publisher of Kalorama Information. "These applications would presage strong growth, reinforcing our model and perhaps as they are implemented, causing a further adjustment."

In late April 2017, researchers from the Broad Institute of MIT and Harvard, other institutes and departments at MIT (Massachusetts Institute of Technology) and Harvard, Howard Hughes Medical Institute, and the National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health published an article in Science entitled "Nucleic acid detection with CRISPR-Cas13a/C2c2." In this article, they describe a CRISPR-based diagnostic (CRISPR-Dx) which they called Specific High-Sensitivity Enzymatic Reporter UnLOCKing (SHERLOCK). This platform combines the Cas13a enzyme (which targets RNA) with isothermal amplification. They authors used this platform to detect the Zika and Dengue virus, pathogenic bacteria, cell-free tumor DNA, and other genetic targets.

The use of CRISPR technology as part of a diagnostic platform is another significant step in the CRISPR field. However, Zhang's laboratory is not the research group looking at the potential use of CRISPR technology for diagnostics. For example, also in April 2017, researchers in South Korea published an article Epub ahead of print that describes the use of a CRISPR-mediated DNA FISH method for detection of MRSA (methicillin-resistant Staphylococcus aureus). In situ hybridization represents the overwhelming majority of the molecular histology market and is used to detect disease or infection, determine risk for disease progression, and determine patient sensitivity to targeted therapeutics. The majority of the ISH products are related to cancer, cancer risk, and related proliferative disorders. Technologies used downstream of hybridization techniques such as flow cytometry, PCR, sequencing or mass spectrometry are not captured in the market scope of this chapter.

Fluorescent in situ hybridization is used in both pre- and postnatal testing of genetic disorders as well as testing in adults. Prenatal testing is a major growth market available to FISH, but the technology has been undercut by non-invasive prenatal testing (NIPT) options such as microarray-based comparative genomic hybridization (aCGH) and NGS that do not require amniocentesis. At this time, the application of CRISPR technology to diagnostic testing appears to be in a relatively early stage of development. However, the April 2017 article in Science demonstrates that CRISPR technology can be used for a broad range of applications, and the SHERLOCK platform may be an inexpensive platform that with the potential to transform areas of diagnostics.

These forecasts were made before diagnostic technologies were projected. Molecular testing is already a 7 billion-dollar market with tremendous growth potential, according to Kalorama.

Kalorama Information's report on Gene Editing Markets contains projection for the CRISPR market as well as other technologies. The report is available at https://www.kaloramainformation.com/Gene-Editing-CRISPR-10347331/.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

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Bruce Carlson
212 807 2262
bcarlson@marketresearch.com

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SOURCE Kalorama Information