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In the cancer diagnosis landscape, MSInsight rises to the challenge— detecting Microsatellite Instability (MSI) in patient DNA. MSI is a crucial biomarker in cancer care, as it is predictive of response to immunotherapy, but spotting it accurately is no walk in the park. Current ways of finding MSI in various cancers aren’t cutting it; they are either not sensitive enough or stuck dealing with specific types of cancer. MSInsight steps up to the plate with MSIcare, a brand-new diagnostic tool ready to tackle this need.

65 remaining days
100 investors
Investment achieved
367.095€
Target
500.000€
Invested
73.4%
75% COMMITTED ? Amount of committed pre-campaign investments in the form of reservations or signed letters of intent.
COMMITTED : 5.500,00
367.095
73.4% INVESTED
Maturity

Prototype/preclinical

Premoney valuation

2.500.000

Estimated exit

2029-2030

Sector

Diagnosis

Equity offered

20%

Minimum investment

500

FR based flag
Equity L
Tax deduction L
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Overview: MSInsight

Valuation 2.500.000
Estimated return x34
% Offered 20%
Estimated exit 2029-2030
The company

Cancer management is undergoing a profound transformation. Precision medicine has led to significant advancements in tailoring the treatment of each tumor based on its molecular characteristics at the DNA level.

MSInsight aims to tackle the daily challenge healthcare providers face: decoding a complex biomarker at the patient’s DNA level, representative of a family of common cancers called Microsatellite Instability (MSI) cancer.

The detection of the MSI biomarker dramatically guides patient care and therapeutic choices toward an effective new treatment—immunotherapy. Indeed, oncologists need access to trusted insights to tailor their clinical decisions, which MSInsight can provide.

Nowadays, this diagnostic is systematically recommended for any newly identified tumor, regardless of the origin of the cancer tissue (pan-cancer). It also aids in the early detection of familial predispositions to develop this type of cancer (Lynch syndrome).

In clinical practice, this widespread adoption requires suitable methodologies to perform large-scale screening with high precision in pan-cancer that could potentially impact 13 million individuals worldwide yearly. And the current reference tests fall short of current needs.

Introducing a Novel Bioinformatics Platform

At MSInsight, we are shaping the future of MSI diagnosis, harnessing the potential of a high-throughput DNA analysis technology: Next-Generation Sequencing (NGS). NGS is already routinely used in clinics for other genomic biomarkers than MSI and promises to be highly efficient in evaluating MSI. However, the interpretation of the generated genomic data relies on sophisticated algorithms, and those currently available are not precise enough, resulting in diagnostic errors in up to 30% of cases, leading to dramatic consequences for patients.

In collaboration with a reputed research team in the field of MSI cancer (Inserm), extensive work has been done to understand the reasons behind the poor performance of current tests and propose new, clinically validated, and highly reliable algorithms.

We are developing MSIcare, a software incorporating state-of-the-art bioinformatics algorithms derived from our groundbreaking research. By analyzing genomic data obtained by clinical laboratories, MSIcare identifies MSI with unparalleled precision, whether from patient tumor tissue or a blood sample, and in ALL cancer types. The next stage of development will encompass the regulatory studies and certification of MSIcare, as an in vitro diagnostic medical device.

Our Ambition: To Become the One-Stop Shop MSI Diagnostic Solution

We strive to become the leading player in NGS-based MSI diagnostics, covering the entire patient journey from early detection to treatment response prediction. Our goal is to support healthcare professionals by providing reliable patient-specific information that will help monitor their patients and support their medical decision-making.

MSInsight initially targets the NGS oncology genomic testing market, estimated at $12 billion. MSInsight has significant growth potential, as the future lies in the widespread use of MSI diagnosis regardless of the stage of the disease and the tumor type, the democratization of NGS in clinical routine, and substantial investment by biopharmaceutical industries in immunotherapies targeting MSI cancers. Ultimately, our solutions will benefit hundreds of thousands of individuals worldwide, directly improving their care.

MSInsight will operate on a B2B model, engaging directly with the hospital and private NGS laboratories, specialized genomic service providers, and biopharma companies. The company has formulated a competitive pricing strategy rooted in a value-based approach. To broaden our market and reach more customers, MSInsight will collaborate with strategic distribution partners.

We anticipate achieving a revenue of over €22 million by 2030, deploying MSIcare initially in Europe and North America, and then Asia. Our strategy aims to expand into other markets with complementary applications, such as companion diagnostic tests by biopharma partnerships and genetic tests for hereditary MSI cancers.

How confident are we?

We rely on a solid medical foundation, as exposed below :

We genuinely tackle the shortcomings of market leaders. Our understanding of MSI detection complexity is robust. Independent publications and clinical demonstrations underscore our superiority to existing solutions. We have established collaborations with eminent research institutes and hospitals in the field, enabling access to unprecedented data collection for developing our models. We have partnered with diverse expert service providers for technological development, regulatory compliance, and prototyping. The current installations in labs are the bedrock of our legitimacy and are open to attractive perspectives.

Industry professionals recognize our project and take pride in it. It has garnered prizes and grants, including winning the 25th i-Lab award (€ 250k grant), progressing to the final stage of the EIC Accelerator, as well as awarding an extra €1.3 million grant to our research partner dedicated to our collaborative efforts.

Why is Capital Cell investing in this company?

MSInsight is introducing MSIcare, a cutting-edge platform for the precise detection of the MSI biomarker using Next-Generation Sequencing (NGS) technology. Traditional testing methods like PCR are slow, lack sensitivity, and are not scalable, making them unsuitable for widespread screening. Existing NGS-based tools have a false negative rate of up to 30%. In contrast, MSIcare boasts a clinically validated 0% false negative rate, offering a significant advancement in speed and accuracy. This makes MSIcare ideal for large-scale screening, diagnosis, and the development and monitoring of personalized therapies. Experts have praised the scientific and technological robustness of this proposal.

MSI screening is already a standard in colon cancer, with testing rates in the US increasing by 15% from 2019 to 2021. MSIcare's adaptability to various tumor and sample types broadens its market potential, and its superior performance suggests strong market uptake and penetration prospects. Additionally, sequencing results from MSIcare can identify other biomarkers. The platform is protected by two exclusive patents from Inserm and one co-owned with them, ensuring complete operational freedom. While some experts considered market share and revenue projections optimistic, the overall business plan is deemed solid.

Minimum investment: 500
Type of exit expected: Exclusive acquisition, buyout by an industry player in the diagnostic field
Drag-along rights
Tag-along rights
Tax deductions
Our company qualifies for French residents with a 50% tax incentive.
Main risks

Obtaining regulatory approval, essential for clinical use, and further clinical validation to confirm its efficacy are necessary steps.

Additionally, integrating MSIcare into standard care will involve demonstrating its significant benefits to healthcare systems and achieving market penetration will require effort in a competitive landscape.

More information

Universal MSI diagnosis for all cancers

Enhanced diagnostic precision through unique algorithms

Seamless integration into existing workflows

Our experts say

This is a very well-rounded team of scientific and business experts, with partnerships already identified and established and with a clear roadmap on how the investment will be used to achieve the milestones.

Adrienne Leussa

Phd in biochemistry and MBA from the University of Johannesburg.

The innovation addresses a key process in tumor cells and could be important for developing new therapies or improving current therapies.

Lucie Mondoulet

Senior advisor at Paris Saclay Cancer Cluster

High business potential focused on a large and growing market, which is supported by excellent strategic partnerships.

Jokin Carrillo

Associate Director, Medicinal Chemistry at Gain Therapeutics

The final rating

APPROVED: This company has successfully passed a rigorous legal and financial analysis.

Approved by
The BioExpert Network is an independent and exclusive network of experts in the life science industry and investment. Only proposals that receive positive evaluations in innovation, science, finance... make it successfully through to the funding campaign stage of Capital Cell.
Team
73%
Science
72%
Innovation
75%
Business
71%
Approved by
Alira Health is an international consultancy that provides a suite of integrated services designed to help companies in the healthcare and life sciences sectors.
Market access
70%
Regulatory
80%
Approved by
Elion is an intellectual property (IP) agency, which helps biotech and medtech start-ups with their protection strategies, patent drafting and prosecution, as well as freedom-to-operate studies.
Intellectual Property
87%

The project

MSInsight utilizes cutting-edge DNA sequencing to deliver highly accurate cancer tests, ensuring precise diagnoses and tailored treatments.

Our vision is to establish MSIcare as the new gold standard in our market.
The current fundraising aims to conduct the clinical performance evaluation of our first test, diag-MSI, ensuring it meets medical device regulations and quality standards to submit an application for European and US approvals (CE-IVD marking and FDA 510(k) approval). Completing these steps within the next 18 months is a pivotal milestone in establishing MSIcare as a reliable and compliant diagnostic solution for healthcare professionals and patients in clinical settings.

The strength of our successful demonstrations highlights why now is the time to invest in our project, as:

Large datasets to feed our advanced algorithms. We exploit several well-annotated biological and tissue sample collections from patients. Competitor algorithms are based only on a restricted number of samples and less qualitative cohorts. Our first validation on large cohorts of colorectal cancer samples (800+) improves the detection sensitivity of the MSI biomarker by 30% compared to the Msi.sensor reference test bringing it near perfection with a 100% sensitivity. To validate our results, we always conducted a systematic concordance comparison with gold standards, including IHC and PCR (if relevant).

Comprehensive diagnosis across tumor types. MSIcare holds significant potential for detecting MSI in pan-cancer, notably in tumors in which PCR is not performant at all. So far, trials have been carried out on stomach cancers, endometrial cancers, and glioblastomas showing promising results. We are consolidating these results in a vast array of 16 tumor types.

Targeting relevant microsatellites for each tumour type. One of the key novelty points of our solution is to focus on mutations within a specific type of microsatellites (repetitive sequences in the DNA), which have been shown to offer superior sensitivity and accuracy in detecting instability. Our research has identified over 400 of the most relevant microsatellites of interest.

Bypassing the need for matched healthy tissue. Our method was optimized to evict the need for a personalized comparative analysis between tumor DNA and the matched healthy (non-tumor) DNA. Non-tumor tissue from patients isn’t always readily available, hindering access to the diagnosis using MSI-PCR and MMR-IHC tests when surgery isn’t an option or when the tumor tissues are insufficient. Moreover, most genomic tests routinely performed by NGS (detection of other mutations on oncogenes) only require tumor tissue. Having a method for detecting the MSI biomarker under the same conditions will increase the practicability of our test for users, providing an advantage over our competitors.

Extending MSI detection to circulating tumor DNA. This barrier was pushed further by developing the algorithm so it could efficiently detect MSI on circulating tumor DNA, outside the primary tumour site from blood samples. The ability to track and even quantify MSI in the blood of patient’s tumors represents a significant clinical advance, not only in the setting of residual disease detection but also in monitoring Lynch patients (hereditary cancer syndrome).

Current traction. We recognize the critical role of strategic partnerships in realizing our vision. We have compiled evidence of early market traction and forged strong alliances with prestigious research institutions (Inserm, AP-HP, Sorbonne University), the MSI cancer French national network, and leading molecular oncology and MSI research experts. It will be invaluable in advancing our understanding of the complexities of MSI detection and validating innovative algorithms for NGS-based diagnosis to support our journey to market.

Our team

At MSInsight, our team is the driving force behind our mission to empower cancer diagnosis and personalised medicine. With a collective background of over 50 years in oncology research, we are committed to making a meaningful impact in the field of MSI diagnosis through genomic data. Our team is not just building a product; we are building a future where precision oncology becomes a reality for all.

Management team

Arnaud Cutivet, PhD , CEO
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Before founding MSInsight, Arnaud served as the Deputy Director of the Cancer Cluster CLARA. He facilitated numerous technology transfer projects in oncology with biotech and medtech startups, and led several strategic partnerships with pharmaceutical laboratories. Notably, he successfully managed grants totaling €8 million.
Earlier in his career, Arnaud led innovation at Indicia Biotechnology, an immunotechnology services company.
Arnaud holds an engineering degree from ENSICAEN and a PhD in biotechnology from UTC.

As CEO of MSInsight, Arnaud oversees the company's development and management strategy, as well as business development.

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Alex Duval, MD-PhD , CSO
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Alex is full professor of medicine at Sorbonne University, specialized in Cancer Genetics. He has been directing an Inserm team for over 18 years in Paris with research activity dedicated to MSI cancers.
As a medical doctor, he heads the MSI precision medicine cancer diagnostics laboratory at the La Pitié-Salpêtrière Hospital, Paris.
He is an internationally recognized opinion leader regarding the personalized care of these tumors. Translational genomic research activities aims at discovering new risk factors, biomarkers, and diagnostic tools, some of which have been patented, licensed and used in routine clinics.
He has over 120 publications and 10 patents.

At MSInsight, he is in charge of our scientific programs.

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Toky Ratovomanana, PhD , CTO
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Toky possesses expertise in bioinformatics and genomics, specializing in the application of IT and programming to enhance genomic research.
His focus is on the integration of bioinformatics tools and machine learning for analyzing cancer genetics, notably microsatellite instability. Actively involved in research and development in oncology genomics, demonstrating proficiency in high-throughput genomics, single-cell analysis, and leveraging deep learning for gene expression analysis.
His research aims at improving the predictability of treatment responses in colorectal and breast cancer, striving to identify novel biomarkers and facilitate biological interpretations of AI models.
His work was awarded by "Pépite" national contest and the French Society of Personalized Medicine.

In 2022, he co-founded MSInsight and acts as a Chief Technical Officer

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Olivier Exertier, eMBA , CFO
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Olivier holds an Executive Health MBA.
Manager specialized in the healthcare sector, he spent more than 15 years working as a senior manager in management consulting, in charge a business unit dedicated to life science (Algoé Consultants). Consequently, he has supported numerous entrepreneurial and innovation projects in oncology and infectiogy.
He served as the Director of the Cancer Cluster CLARA for 4 years before joining the Director's Office of the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO).
Additionally, Olivier is a member of an investment fund in life sciences.

At MSInsight, he is in charge if the financial management and fund-raising.

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Florence Renaud, MD-PhD , Medical Advisor
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Within Paris Hospital, Florence is an anatomopathologist specialized in MSI diagnosis. Her scientific interests lie in digestive oncology, digestive pathology, molecular biology, and digital pathology. She also holds a position as an associate professor at Sorbonne University.

At MSInsight, she plays a key role in shaping the company's medical strategy.

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Ada Collura, PhD , Scientific advisor
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Ada holds a Ph.D. in Genetics from University of Paris Sud. She is currently a Research Associate and conducts her research activities within an Inserm team at Saint-Antoine Research Center.

At MSInsight, she is involved in our scientific strategy and the implementation of our R&D programs.

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Key team members

Mélyna Koutima
Quality & Regulatory Affairs Engineer
Mathieu Danière
Software Developer
Sydney Normand
Marketing & Market Access Specialist

Advisors

Marie-Anne Lauferon
Business Development Strategy
Christophe Amiel
Regulatory Advisor
Alexandra Carrel
Outside Counsel
Agnès Lamoine
Certified accountant
Bastien Fournié
Patent Attorney

The problem

Today, considering its clinical relevance and international guidelines recommendations, Microsatellite Instability detection has become instrumental in oncology diagnosis and hereditary cancer testing.

However, healthcare professionals face daily challenges with the solutions at hand. The search for MSI is mainly done using a gold-standard PCR-based protocol. PCR protocols do not address current needs. They lack sensitivity, leading to diagnostic errors, and are not adaptable to diverse cancers. In light of the increasing number of potential patients, this approach lags as it is unsuitable for high-throughput testing and scalability with blood samples.  

Combining robustness, speed, and large-scale analysis, Next-Generation Sequencing (NGS) has recently emerged as a highly efficient, compatible, alternative approach. As it grows increasingly more common and cheaper, NGS is becoming a method of choice for MSI screening, particularly for pan-cancer diagnosis and patient monitoring, as it allows for genome analysis using tumoral tissues and simple blood draws. 

However, the complex data generated requires sophisticated algorithms. Available solutions do not meet the expected accuracy, causing up to 30% misdiagnosis. Patients are being incorrectly directed towards therapeutic programs unsuited for their condition, leading to dramatic consequences for these patients and unnecessary healthcare expenses. 

The solution

Interpreting the genomic data generated by NGS remains a critical challenge, especially for identifying mutations in DNA microsatellite regions. At MSInsight, we empower laboratories with high-performance and accurate solutions, to foster trust and confidence in their diagnosis.

MSInsight brings a game-changer to the table — MSIcare, an in vitro diagnostic medical device software that incorporates state-of-the-art bioinformatics algorithms and artificial intelligence models derived from our research.

MSIcare is a comprehensive solution for detecting MSI throughout the patient’s journey, from early detection of familial predisposition to MSI cancer to diagnosing MSI in various types of cancer and predicting/monitoring therapeutic response. Our clinical studies demonstrate that MSIcare identifies MSI with unparalleled precision compared to existing solutions, whether from patient tumor tissue or a blood sample and in all cancer types.

MSIcare is designed as a modular platform, evolving with the integration of our bioinformatics as development progresses, addressing needs at each stage. Our initial development focus is on the diag-MSI solution, which is dedicated to detecting MSI from tumor DNA.

We have secured our IP with patents, copyrighted algorithms, and undisclosed know-how for each application, including dedicated microsatellite databases.

Our differentiation

The diagnostic assessment of MSI through NGS encompasses diverse solutions with unique specifications and limitations. The lack of a standardized and universally validated approach poses challenges in ensuring consistent and reliable results across various cancer types.

MSInsight has worked on deciphering the reasons behind the poor achievements of the existing algorithms to outperform them. Drawing on our unique bioinformatics expertise and MSI cancer knowledge, our tests rise to the challenge with a sensitivity close to 100%.

Our competitors, primarily service providers in genomics and bioinformatics, often lack transparency in clinical validation, leading to skepticism among healthcare professionals. This highlights the need for a robust and transparent solution, a gap that MSIcare aims to fill. Our comprehensive comparative study with existing solutions has brought attention to their limitations.

The bioinformatics algorithms we developed set us apart from competitors, providing:

Reliable and Universal MSI diagnosis

MSInsight’s innovations are based on a network of experts (Inserm, AP-HP) in MSI cancer care. It gives us exceptional clinical cohorts of thousands of pan-cancer data points. Evidence of the performance of our models is acquired using large cohorts of pan-cancer samples (more than 6000) perfectly annotated and compared to current standard methods (MMR-IHC, MSI-PCR, MSI.sensor).
Unlike others, we offer MSI diagnosis across all cancer types without needing comparative analysis of healthy tissue. Our method requires only a single sequencing from DNA derived from either solid tumor tissue samples or liquid biopsies.

Adaptable User Environment

Our solutions seamlessly integrate into the client’s NGS workflow without altering sequencing conditions. This adaptability contrasts with competitors who limit their data interpretation to their sequencing protocols, allowing us to cater to a broader client base with diverse needs. MSIcare optimizes both time and cost for users by automating analysis without dedicated bioinformatic expertise and providing results within an hour. The process is further streamlined as it uses the same NGS sequencing results for searching other genomic biomarkers, eliminating the need for duplicating tests with PCR.

Functional Scalability

Beyond accuracy, MSIcare addresses diagnostic needs that are unmet by other solutions. We aim to push the boundaries of this service by enriching MSIcare with new functionalities for:

  • Monitoring hereditary predispositions to MSI cancer.
  • Predicting treatment response.
  • Monitoring patients going through these new precision treatments.