Biocartis

Molecular diagnostics beyond simplicity

Biocartis aims to provide direct access to personalized medicine for patients worldwide by developing fully integrated and broadly applicable molecular diagnostics. Our platforms can be used in a wide variety of healthcare settings to enable rapid and high-quality care close to patients.

Idylla™

Idylla™, Biocartis’ fully automated, real-time Polymerase Chain Reaction (PCR) based molecular diagnostics system, is designed to offer physicians fast access to highly reliable clinical molecular diagnostic information, anywhere and anytime. Idylla™ detects and quantifies multiple DNA or RNA-based biomarkers in a wide variety of patient sample types. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the molecular diagnostics (MDx) market worldwide. Today, Biocartis has six oncology tests and two infectious disease tests in its offer.

Personalized Medicine

Personalized medicine is about every person’s unique genetic profile. Understanding and leveraging the molecular mechanisms underlying diseases, empowers doctors to shift away from the one-drug-fits-all paradigm and tailor a treatment to the genetic profile of their patient. Specific molecular diagnostics tests can help make treatments more effective, with better outcomes and as such, reduce healthcare costs.

 

Investors

Biocartis is a commercial-stage, small-cap molecular diagnostics (MDx) company listed on Euronext (ticker: BCART) since April 2015. We develop highly innovative diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Our proprietary MDx Idylla™ platform, launched in September 2014, is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting.

The main value driver is our menu of rapid, easy and highly accurate molecular diagnostics tests, focused on oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. In June 2016, we were active in over 50 countries and had close to 300 Idylla™ platforms installed at clients worldwide.

PRODUCTS

Idylla™ EGFR Mutation Assay (RUO)

The Idylla™ EGFR Mutation Assay allows detection of EGFR mutations directly from formalin-fixed paraffin-embedded (FFPE) tissue sections in approx. 2.5 hours with less than 2 minutes hands-on time.

Idylla™ BRAF Mutation Test

About 50 percent of all melanomas harbor mutations in the BRAF oncogene. Idylla™ BRAF Mutation Test detects BRAF mutations directly from FFPE tissue sections in 90 minutes with less than 2 minutes hands-on time.

Idylla™ KRAS Mutation Test

About 45 percent of all metastatic colorectal tumors harbor mutations in exons 2, 3 and 4 of the KRAS oncogene. Idylla™ KRAS Mutation Test detects KRAS mutations directly from FFPE tissue sections in approx. 2 hours with less than 2 minutes hands-on time.

Idylla™ NRAS-BRAF-EGFR S492R Mutation Assay (RUO)

The Idylla™ NRAS-BRAF-EGFR S492R Mutation Assay allows detection of NRAS, BRAF and EGFR 492 mutations directly from formalin-fixed paraffin-embedded (FFPE) tissue sections in approx. 2 hours with less than 2 minutes hands-on time.

Idylla™ ctBRAF Mutation Assay (RUO)

The Idylla™ ctBRAF Mutation Assay is the first and only fully automated liquid biopsy assay. Discover the benefits of Idylla™ ctBRAF Assay – the easiest solution to implement liquid biopsy testing in research.

Idylla™ ctKRAS Mutation Assay

Using liquid biopsies is minimally invasive, fast and easy to perform and provides an excellent solution to study the presence of KRAS mutations in different cancer types like colorectal cancer, pancreatic cancer and non-small cell lung cancer (NSCLC).

Idylla™ NRAS-BRAF Mutation Test (CE-IVD)

About 5 percent of all metastatic colorectal tumors harbor mutations in exons 2, 3 and 4 of the NRAS oncogene. Idylla™ NRAS-BRAF Mutation Test detects NRAS and BRAF mutations directly from FFPE tissue sections in approx. 2 hours with less than 2 minutes hands-on time.

Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay (RUO)

About 50% of all metastatic colorectal tumors (mCRC) harbor RAS mutations¹. The frequency of NRAS mutations in exons 2, 3 and 4 is around 5%¹. The frequency of BRAF mutations in mCRC is 8%¹.

Vision & Mission

 Biocartis aims to make personalized medicine an everyday reality, by providing direct access to molecular diagnostics information close to the clinical decision-making point. Establishing a new gold standard in diagnostic testing Biocartis delivers innovative and vital solutions to the pharmaceutical and healthcare market. Providing highly automated instruments in combination with novel and broadly applicable molecular diagnostic assays, Biocartis enables personalized molecular testing in a wide variety of medical settings.

About Personalized Medicine

Every person has a unique genetic profile. Understanding and leveraging the molecular mechanisms underlying diseases empowers doctors to shift away from the one-drug-fits-all paradigm and tailor a treatment to the genetic profile of their patient, also known as ‘personalized medicine’. Specific molecular diagnostics tests can, for instance, tell a doctor what drug is the preferred therapy for a melanoma patient whose tumor carries a specific genetic mutation. Eventually, this makes treatments more effective, improves outcomes and ultimately reduces healthcare costs. However, in order to be truly sustainable and beneficial, molecular information needs to be gathered quickly and easily, at the point of need.

Today, this is not the case. Most hospitals do not perform molecular tests in-house, but send the test samples out to specialized labs where they are processed in batches, on multiple instruments and operated by highly trained personnel. This time-consuming and labor-intensive process delays treatment decisions which are often crucial to save patients’ lives.

 

 

TECHNOLOGY

 Idylla™’s sample-to-result functionality stems from the complete integration of all process steps, from sample liquefaction and cell lysis, over DNA/RNA extraction and real-time PCR amplification & detection, to data analysis and reporting.

1. Liquefaction

The physical properties of many clinical sample types make them unsuitable for fluid handling systems. For certain sample types, such as sputum or feces, the viscosity or consistency of the sample is too high while other sample types, such as fresh or formalin-fixed paraffin-embedded (FFPE) tissue, are completely solid. Before such sample types can be adequately processed by fluid-handling systems, they must be liquefied and homogenized.

2. Cell Lysis

The DNA or RNA that needs to be detected can be encapsulated (e.g. the bacterial/fungal cell wall or the viral membrane). Lysis is the process of liberating these target nucleic acids by disrupting the capsule in which they are contained. Certain bacterial and fungal cells have a particularly strong cell wall and disrupting them requires advanced lysis processes.

3. DNA/RNA Extraction

Most clinical sample types contain components that may interfere with the downstream target amplification and detection steps. Hence a nucleic acid extraction step is used to purify the nucleic acids from the sample. This extraction process can also serve as a way to increase the concentration of the target nucleic acids.

4. Real-time PCR amplification & detection

Idylla™’s high sensitivity allows detecting individual target molecules in a background of high amounts of other nucleic acid molecules. This sensitivity is achieved through real-time PCR, a powerful amplification technique. PCR allows a million or billion-fold multiplication of specific target molecules from a sample. Certain assays can detect a single nucleic acid target, while other multiplex assays can detect many different nucleic acid targets.

5. Data Analysis & Reporting

At the end of each test, Idylla™ automatically reports the results. Through bidirectional connectivity with laboratory and hospital information management systems, results can be forwarded with great accuracy and speed.

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