Every year is a new beginning that brings new things to us all, and judging from press releases that have come across my desk in recent weeks, a not insignificant number of new diagnostic assays, particularly for cancer, may come to the clinical laboratory community in the near future. Some are just being developed, or may soon be developed, based on research. Some have been developed but have not been approved by the FDA. Some are now being manufactured and are available through major diagnostics vendors. Let me share some of what I have been reading about lately; it may be part of your lab’s future, this year or in years to come.
OncoHealth Corporation, a protein biomarker diagnostics company, has announced three new studies that demonstrate the effectiveness of assays using its proprietary HPV E6 and E7 biomarkers to distinguish between clinically meaningful cervical disease and insignificant HPV infections. The company asserts that the test could help millions of patients avoid unnecessary procedures each year.
Insight Genetics has been awarded two Small Business Innovation Research (SBIR) contracts from the National Cancer Institute (NCI) to continue developing diagnostic tests that identify and characterize specific mutations in lung cancer patients. The companion diagnostic tests are designed to enhance the accuracy of diagnosis and treatment, in determining which targeted therapies are appropriate for specific patients.
Enzo Clinical Labs has introduced a new diagnostic blood test, developed by Oncimmune, that assists in risk assessment and early detection of lung cancer. It is being made available in the New York metropolitan market, New Jersey, and eastern Pennsylvania. The immuno-biomarker platform provides increased sensitivity while maintaining high levels of specificity.
A new study recently published in The British Journal of Surgery has demonstrated that a simple breath analysis could be used for colorectal cancer screening. Analysis of the volatile organic compounds (VOCs) linked to cancer is a new frontier in cancer screening.
The Mayo Clinic has identified genes that predict the effectiveness of trastuzumab in breast cancer patients. Researchers discovered 27 genes that are significantly associated with a good outcome with concurrent use of trastuzumab and chemotherapy, as well as five other genes linked to a poor outcome using the same treatment regimen. Further analysis will shed light on the biological workings of individual HER2-positive tumors.
Along with information about assays for cancer diagnostics and studies of cancer-related pharmacogenomics, I regularly receive other press releases relevant to molecular diagnostics. One that just came across my desk involves an article published in BioTechniques called “Direct sequencing of small genomes on the Pacific Biosciences RS without library preparation.” The article explains how researchers have sequenced DNA molecules without first preparing DNA libraries to generate sequence data. The new techniques, which require much less DNA than standard methods, have major clinical implications.
Molecular diagnostics, and particularly cancer diagnostics, are major themes of this January 2013 issue of MLO. Another thread that runs through several of this issue’s articles is automation. We are confident that these are topics of significant relevance to the laboratorians for whom we produce each issue—but we depend on your feedback. As we begin a new year, I want to reiterate that I am always glad to read an email or take a phone call from a reader commenting on a particular article or a general direction that the magazine is taking—or suggesting a topic that we might want to pursue. I am also happy to post comments on my blog at mlo-online.com.
As we begin 2013, the MLO staff remains committed to making the magazine as useful for you as it can be.