The rise of molecular biology has revolutionized the diagnosis and treatment of diseases. Modern test methods, based on the detection of DNA and RNA, offer many advantages over traditional methods for the detection of diseases. The new procedures can detect viruses, bacteria and genetic variations faster and much more accurately. Treatments can be tailored better to individual patients.

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QIAGEN technologies can detect many pathogens from their nucleic acid sequences. Modern technologies can also offer novel insights into disease progression and treatment options, which were not possible in the past.

QIAGEN offers a comprehensive range of Sample & Assay Technologies for molecular diagnostics, including automated solutions. In this way, QIAGEN products cover all relevant areas of healthcare: from early diagnosis of diseases (Prevention), the establishment or confirmation of diagnoses (Profiling) and testing of patients who have already been diagnosed in order to determine the most suitable treatment (Personalized Healthcare), through to applications where a result is needed urgently or lab facilities are not available (Point of Need tests).

Prevention

Thanks to modern molecular technologies, many diseases can be detected quickly and reliably long before the first symptoms appear, allowing the right treatment to be started at an early stage.

Detection of latent tuberculosis (TB) is one example of the benefits of QIAGEN technologies. The World Health Organization reports that up to 2 billion people worldwide are infected with the tuberculosis pathogen. If left untreated, 5 to 10 percent of them will develop the active form of the disease during their lifetime. This means that the detection of latent TB is an important element in the fight against this infectious disease. QIAGEN‘s QuantiFERON-TB Gold In-Tube® (QFT) test is regarded as the gold standard for this, and its reliability and cost-effectiveness mean that it is increasingly replacing the tuberculin skin test, which has been in use for over 110 years to detect latent TB.

Another example is the fight against cervical cancer – the second most common form of cancer in women after breast cancer. Here again, the digene HC2 HPV® Test developed by QIAGEN is the gold standard for detecting infection with the human papillomavirus (HPV), the main cause of cervical cancer. It is the only test that has been shown to be effective in almost 1 million women in clinical trials and independent studies.

QIAGEN has worked with the international nonprofit organization PATH to develop careHPV®, the first HPV test system specifically for parts of the world with limited medical resources. The test does not require access to electricity, running water or a modern laboratory infrastructure. QIAGEN launched careHPV® in 2013 in China.

Profiling

An incorrect or inaccurate diagnosis can be life-threatening for patients. That is why the reliability of the relevant tests is so important, especially when a disease has already developed. Molecular tests, the use of which is referred to as “Profiling” in this context, are in most cases far superior to conventional methods of diagnosis because of their speed and accuracy.

QIAGEN is the global leader in Profiling. It offers more than 120 methods for detecting various pathogens, including the flu virus, the HI-virus that causes AIDS, as well as hepatitis B and C viruses, which cause life-threatening diseases. QIAGEN also sells multiplexing methods that can be used to detect several different pathogens in the course of a single test run.

In order to further extend its leading position in Profiling, QIAGEN is constantly introducing innovations leading to progress in clinical practice. One of the main aspects is combining the advantages of molecular tests with the efficiency of automated systems. The success of this is demonstrated by the marketing authorizations that have been granted following stringent approval procedures, such as the recent US approval of QIAGEN’s test to detect influenza viruses in combination with the Rotor-Gene Q MDx® detection platform.

Personalized Healthcare

Patients often respond differently to drugs they are taking, independent of influencing factors such as age or weight. A drug that works for one patient may not work for another, or may even cause harmful reactions. It has been known for years that this is mainly due to the diversity of human genetic material. A better understanding of such differences in the human genome helps doctors to select and tailor treatments. This is the basis of personalized medicine.

Tests in Personalized Healthcare, known as companion diagnostics, are carried out once a disease has been diagnosed in order to choose the best possible treatment for the patient according to his or her individual genetic makeup. For example, many novel, targeted cancer treatments are very expensive but only work in patients with a particular genetic profile. For example, anti-EGFR inhibitor treatment for colorectal cancer only succeeds if the tumor does not have mutations in the KRAS gene. Companion diagnostics performed to guide treatment options not only improve the patient’s chance of a good treatment outcome but also help make the best use of scarce healthcare resources. It is clear that the future belongs to personalized medicine.

QIAGEN is the world’s leading independent provider of companion diagnostics for Personalized Healthcare. It already markets more than 30 tests for applications in this area. And it is helping science progress: QIAGEN is involved in over 15 projects researching new tests to be carried out in conjunction with treatment, working with leading pharmaceutical companies such as AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, Eli Lilly & Company and Pfizer. QIAGEN also established the first blockbuster segment in personalized medicine with its KRAS tests for personalization of colorectal cancer treatments.

Point of Need

For many years, only specialized laboratories with specific infrastructure were able to use modern diagnostic technologies. Technological progress means that these methods are increasingly becoming available for use in environments without access to a permanent laboratory infrastructure, for example in emerging and developing countries or in situations where results are needed urgently, such as in intensive care and emergency medicine.

QIAGEN is also active in this field, and was a pioneer in Point of Need tests thanks to its portable ESEQuant systems. The ESEQuant Tube Scanner is the size of an office phone, can be run on batteries, and is able to detect multiple molecular targets in a single test run. QIAGEN has also developed the ESEQuant Lateral Flow System, a product designed for protein-based Point of Need tests.

QIAGEN is also working on the development of new applications for Point of Need tests. One example is a series of tests to detect a heart attack in emergency medicine, developed by Lepu Medical for the ESEQuant Lateral Flow System. And QIAGEN’s AmniSure® test shows whether a pregnant woman’s amniotic membrane has ruptured prematurely. Quick and accurate diagnosis of this condition can prevent serious consequences for the health of mother and child.