Molecular Biology

As an innovator in real-time HIV viral load detection, bioMérieux is building its molecular diagnostics offering with a growing line of assays for infectious agents and cancers. Our proprietary isothermal platform, NASBA®, allows the rapid detection of both RNA and DNA-based targets. Our universal extraction technology, BOOM®, has been widely licensed to other diagnostic players, underscoring its outstanding strength and performance. bioMerieux’s proprietary automated extraction system, NucliSENS® easyMAG®, has gained broad recognition for its research and commercial applications.

FIELDS OF APPLICATION: A WIDE RANGE

Molecular biology tools bring a very sophisticated level of sensitivity and specificity to diagnostics. These tools can detect a bacterium, virus, yeast, parasite or genetic marker through the presence of DNA or RNA genetic sequences in a blood sample. Tests are performed directly on a clinical sample and make it possible to obtain results in just a few hours.

These tests are used to detect pathogens (bacteria, viruses, yeasts), identify antibiotic resistance mechanisms, and measure the quantity of a virus, such as HIV, in the blood. They thus allow choices to be made about a specific treatment, monitor its effectiveness, and determine how human cells react to a disease or infection.

Identifying patients who will be responsive to a given treatment, and those for whom such therapy may cause significant side effects, represents a recent application for molecular biology. In this field, called theranostics, bioMérieux is working in partnership with the pharmaceutical industry. The company is also developing theranostics through the ADNA program (Advanced Diagnostics for New Therapeutic Approaches). Theranostics is set to become an important area of development in the future.

TRACKING BIOMARKERS

Research into applications

  • Identifying markers of breast, colon and prostate cancer for the purposes of early disease detection, in collaboration with ExonHit
  • Therapeutics (France) and Affymetrix (USA).
  • Identifying markers for septicemia and inflammatory diseases. Research in collaboration with the bioMérieux-Hospices Civils de Lyon joint research unit, among others.
  • Detecting pathogenic agents in humans, especially emerging viruses (avian flu, respiratory infections, bacteria that are resistant to certain antibiotics, yeasts, pneumococci, etc.).
  • Measuring viral load (HIV, hepatitis B virus, etc.)
  • Detecting pathogenic bacteria (salmonella, Listeria, etc.) to ensure safety in the agri-food sector.

MAJOR INVESTMENTS

Centre Christophe Mérieux – Grenoble, France

The global center for bioMérieux molecular biology and microsystem activities, this state-of-the-art research laboratory, designed and launched by Dr. Christophe Mérieux, opened in 2006. Work is currently underway to significantly expand the center.

It houses chemistry, molecular biology and systems engineering labs, seven of which are BL2 facilities, and two of which are BL3 grade, meeting the strictest safety standards.

The Christophe Mérieux Center is located in an exceptional scientific environment, as part of Grenoble's scientific park. It is close to the CEA (French Atomic Energy Commission) national research facility, which includes a joint bioMérieux/CEA-Léti research unit, and Minatec, the largest research center in Europe dedicated to micro and nanotechnologies. This complex is part of the Lyonbiopôle technology cluster, which pools the scientific resources of the universities, hospitals, and industry in the Rhône-Alpes region.

Fudan University Cancer Hospital in Shanghai, China

The FUCH-bioMérieux Laboratory, located in the biggest cancer hospital in China, aims to achieve the molecular characterization of breast and colon tumors in order to identify patients who would benefit from targeted treatments.

bioTheranostics – San Diego, California USA

bioMérieux strengthened its position in molecular biology with the acquisition of California-based AviaraDx (renamed bioTheranostics) in 2008. This company is specialized in molecular diagnostics for the molecular classification of cancers and to help oncologists choose the best treatment strategy.

The company has developed two innovative products based on proprietary technologies:

  • Theros CancerTYPE ID® provides cancer classification for metastatic cancer where the origin is uncertain or unknown,
  • Theros Breast Cancer IndexSM offers a prognosis assessment and treatment response prediction for chemo and hormonal therapy.

bioTheranostics also has a high complexity CLIA* certified laboratory in which the tests are performed. The laboratory accelerates the development of tests with new biomarkers:

  • The CLIA lab allows early introduction of the biomarkers to the clinical community through the testing service it provides,
  • Subsequently, bioMérieux is able to make the biomarkers more widely available by transferring them onto our global installed base of diagnostics systems.

*CLIA - Clinical Laboratory Improvement Amendments

EACH STEP FULLY MASTERED

Extracting the genetic material (DNA, RNA) from the sample: The quality of extraction is critical to ensure the reliability of the final result.

Amplification is an essential step to allow the multiplication of the target and therefore increase the sensitivity of screening. Often the quantity of the infectious agent contained in the sample is too small to be detected directly.

Detection: copies produced during the amplification process are detected by small molecules called probes, which are designed to bind to the target, if it is present in the sample; they release a fluorescent signal that reveals certain pathogens or gene variations. Through the utilization of probes containing different fluorescent markers, several genetic targets may be detected simultaneously in a single sample. DNA chips, which may contain up to thousands of different probes, make it possible to increase the number of analyses that can be performed at the same time.

With a number of recent methods, such as, for example, the NucliSENS EasyQ® system from bioMérieux, the steps of amplification and detection are performed simultaneously.

Our proprietary technologies
We continue to develop a wide range of “new generation” solutions in molecular diagnostics based on our proprietary technologies:

  • BOOM® is the technology used for RNA or DNA extraction from a sample.
  • NASBA® is a real-time enzyme amplification technology developed for RNA or DNA targets. It is particularly useful because of the ease with which it can be applied to RNA. Messenger RNA synthesized in the cell nucleus is the marker for cellular activity. It is a sign that a pathogen is active. Cancer screening tests are based on the detection of messenger RNA synthesized by tumor cells. RNA is also the genetic medium for a large number of viruses, including HIV.
  • Beacon® is a detection technology that bioMérieux has licensed from the Public Health Research Institute (USA).
Pioneering diagnostics