Invivoscribe was founded to provide standardized tools to the research community. The same emphasis is placed today on all of Invivoscribe's manufactured products. Standardization is crucial because in the diagnostic community there can be such heterogeneity in the way testing is done. This lack of standardization results in discordant test results and an inability to compare results between test centers. Standardization needs to be emphasized right from the beginning, as it should include specimen procurement, transport and processing, and every process leading to generation of a final test result. Standardization can and should result in established consensus guidelines for intended use and test interpretation; this standardization benefits all participants.
If we harmonize the upfront capture of critical clinical information in a way that protects both patient privacy and comports, and is consistent with rules and regulations of the international community, and we standardize specimen processing and storage—everyone in the international community will be better served, and patients will be more likely to see pharmaceuticals become available more quickly.
Harmonization
Standardization in combination with harmonization will enable technologies to reach even further to everyone’s benefit, most notably the
patient. For years clinical research has been driven by biotech and pharmaceutical companies, academic institutions, and research centers competing amongst themselves for funding, discoveries, and development and release of commercial products. Clinical research is expensive and is only successful when participants minimize research
costs and efficiently generate useful data. This has been the time-honored rational approach. However, for the benefit of the patient and to address escalating costs we simply have to evolve. Currently, clinical research occurs
using a variety of methods for sample collection and
processing, and a variety of platforms for experimentation and analysis, so there has been and continues to be a systematic loss in our collective ability to generate
data that can be adequately compared and evaluated between test centers; lack of standardization is jeopardizing the value of data and access to properly archived clinical specimens - so that information
and bioinformatics may never be compared or captured from the majority of clinical samples.
Working together
Invivoscribe is confident that when the scientific and medical community work together we will achieve a level of standardization while protecting
patients’ rights and privacy. An example of this spirit of cooperation was the symposium on clonality testing that we organized just prior to the 2008 annual meeting of the AMP. The purpose of this symposium was to bring together the experts from the international community. The symposium
looked at ways that some of these gene rearrangement tests are being done by a consortium of
laboratories in Europe, and by leading laboratories in the US. We expected to have between 30 to 50 attendees and more than 300 showed up. It was a wonderful opportunity to get feedback from people
who are practicing the technology and the group of scientists and physicians from leading institutions worldwide who are
actually using our tests, or are developing and using their own Laboratory Developed Tests. We are currently incorporating the feedback and what we learned from this symposium into our next generation tests.
Are you willing and BCR/ABL?
Many of the world's leading clinical laboratories have participated in our international BCR/ABL RT-QPCR standardization & harmonization project, "Are you willing and BCR/ABL?". The deadline for the return of data from this phase of the project is October 15th, so if you want to participate, contact us immediately.
More than forty of the fifty plus participants have sent back their data for analysis and we have returned their laboratory's, our laboratory's, and the group's anonymized test results.
Data we received from participants prior to the abstract deadline (data from 36 labs) were included in an abstract we jointly submitted for the ASH meeting, which will be held later this year.
Please note: it is not too late to take part in this important study, but you must hurry if you want to participate as all data must be generated and returned to us by October 15th.
To learn more on how you can participate please contact: bcrablproject@invivoscribe.com
Invivoscribe announces collaboration with ATCC
Invivoscribe has entered into a comprehensive agreement with American Type Culture Collection (ATCC) to standardize controls.
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