Biochemist Luis I. Gomez and medical computer scientist Haroon Ahmad founded INDAGO GmbH, a privately financed research & development company based in Leipzig, Germany to develop a new laboratory technology as described in their 2003 vision statement:
Imagine an affordable blood test, which could provide an individual “fingerprint” of your metabolism, detecting the causes of emerging diseases before they manifest or symptoms even appear. That would be the beginning of real medical prevention. After ten years of research and development INDAGO has developed a polymer-pattern-based
platform technology, which is capable of detecting minute concentrations or fractions of molecules from a blood sample and assigning them to the onset of dysfunctions or diseases of various organs.
As quantitative measurement of molecules can be difficult, the development team developed an innovative new approach – to visualize and analyze the molecules qualitatively.
This brought about a whole new way of thinking about blood as an analyzable compartment. INDAGO started developing a method to isolate molecules based on technology usually used by material sciences. By converting the “biological substance”, in this case blood, into its chemical components using thermal cracking, fragments of nearly all substances can be resolved in an aqueous solution and can then be aggregated into new forms: polymers.
From one blood sample, thousands of different polymers can emerge in a single conversion. After stabilizing the laboratory process, INDAGO started to trace each morphology back to its metabolic origin. At the start, using vast empirical sample sizes, this was achieved by taking blood from patients suffering from known diseases and then matching their polymeric morphologies with the ones of the control group. More recently – after the German governmentowned development bank KfW became a shareholder of INDAGO GmbH – polymers were characterized using scanning electron microscopy and EDAX x-ray units.
Being recognized as an innovative development company, Germanys Federal Ministry of Education and Research (BMBF) and Federal Ministry of Economy and Technology (BMWi) financed two major projects:
- The “EVASYS-Project”: Building a semi-automated prototype to increase the production run, transfer a standardized method to other laboratories and – most importantly – to exclude “human errors” in the required qualitative analyses of the laboratory physician.
- Developing the PSP-Test (Polyp-Specific-Polymers) to detect pre-cancerous colon polyps using the INDAGO test-method as well as proving its efficiency in a double-blind, multi-centric, prospective, open clinical diagnostic study.
Today, both targets are nearly achieved:
The “EVASYS-Project”, which should be completed by May 2014, was started in cooperation with different universities and research companies to build different units for:
- an automated thermal cracking device using infrared-technology, replacing the currently used heat method.
- specially coated object slides for the polymerization process.
- combined Polymerization-Unit with automated placing of different samples into an integrated microscope, followed by
- pattern recognition with a specifically developed analysis software that locates specific polymer patterns from a patient’s blood polymer bulk (see images in attached PSP-study).
On November, 4th 2013 the PSP-study was published in the “Journal of Translational Medicine” which determined that the PSP-Test has a sensitivity of 72.4%, and stated
We believe that this represents for the first time the possibility to effectively identify the highest-risk candidates for endoscopy.
As a non-invasive method, the PSP-blood test is patient-friendly and thus makes an important contribution to a wider acceptance of preventive measures and the participation in regular preventive check-ups for intestinal cancer. Equally important is that the PSP test detects high-risk polyps, which left alone will directly lead to cancer. Removing them is a very effective way to prevent colon cancer from developing.
By combining the best-established, low-risk screening elements with a blood test-based diagnostic test such as PSP that has good acceptance, sensitivity, and specificity, an increase in the reliable estimation of a patient’s risk for CRC before colonoscopy is expected.
One of the unique characteristics of INDAGO’s methodology is the ability to ensure stability in the pattern, shape, size, composition, and structure throughout the whole blood denaturation step, which had previously been considered impossible. As a result, for the first time it has been possible to develop a basic understanding of the relationship between the analytical
results and the disease.
Various studies have shown that early detection significantly increases the chances of curing a patient. Better still is the possibility of detecting harmless adenomatous polyps before they become cancerous. Providing the entire population with a non-invasive, early detection screening method to ensure that everyone at risk is identified and led into colonoscopy is a global challenge.
In Germany, for example, only 2.5 % of the target group (55 years or older, risk group, family anamnesis) undergo a colonoscopy every year. Although the official recommendation is a colonoscopy every ten years only 20 % were screened in the past ten years while 80 % weren’t.
The incidence of 22 % (men) and 18 % (women) of adenomatous polyps within the screened population suggests, that over ten years 1.6 million people will remain undetected out of the 18 million people that were not screened. Extrapolating the figures from Germany to the whole world should give a good indication of the scale of the target market.
Colorectal Cancer (CRC) is one of the most prevalent cancers worldwide with more than 1.2 million new cases per year. It is a sad fact that although CRC is highly treatable if detected at an early stage, it still causes 600,000 deaths every year due to large sections of the population either being reluctant to or unable to undergo regular colonoscopies, which is seen as the “gold standard” detection method.
Although there are other screening methods available, most of them are not suitable for detecting the rather harmless polyps, instead they can only detect the established form of CRC (the Septin-9 Test detects 70 % of CRC but is not suitable for polyps, while the gFOBT only detects 20 – 40 % of CRC).
It is our belief, that a simple and affordable blood test which is capable of finding polyps is the best and most effective way of prevention and the willingness to undergo a subsequent colonoscopy in the case of a positive result will rise significantly.
Buiness Benchmark Data
INDAGO has proven in different case studies that its technology is able to diagnose various metabolic disorders of different organs. It has invented two different diagnostic profiles (called SFT and MSP) customized for physicians specialized in the naturopathic field, bundling different polymer-pattern-based parameters of the gastrointestinal tract, liver, kidney etc. Due to an close partnership with the marketing & sales company Evomed Diagnostics AG,
INDAGO’s client base has grown to 800 practitioners, mainly based in Germany, with a yearly turnover of about 1,350,000 US-Dollars. The day-to-day running of the company and research work is accomplished with 10 employees.
- Mr. Luis I. Gomez – CEO R&D, biochemist
- Mr. Haroon Ahmad – CBDO, medical computer scientist
- Mr. Ralf Schierl – CFO, biologist
Scientific Partners (selection including former Partners)
- Leipzig University
- Leipzig University of Applied Sciences
- Technical University of Darmstadt
- Fraunhofer Institute for Cell Therapy and Immunology, Leipzig
- University of Frankfurt
- German Sport University of Cologne
- Members of the Max-Planck Institute for Polymer Research,Mainz
- companies: Kapelan Bio-Imaging GmbH, Hotho Data GmbH, Universal GmbH
The SFT and MSP profiles have demonstrated their medical efficiency through over 100,000 empirically proven analyses, but due to a lack of clinical studies the profiles are not yet suitable for conventional medicine. Further research will be necessary to establish new parameters and markets.
However this research will be useful in developing new parameters to widen the application of the automated solution. In addition, the solution can take full advantage of an existing platform technology, by only having to extend the pattern recognition software, as all possible polymers are already created in the production process.
Planned new Markers:
- Early detection of Breast Cancer, Lung Cancer, Prostate Cancer, Liver Cancer
- Verification of Alzheimer’s disease
- Verification of articular cartilage degeneration diseases (joints, bones)
- Verification of silent chronic inflammatory syndrome (bowel, joints, blood vessels)
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