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Falcon R&D Program

 

As the Falcon bird is known to be an intelligent creature with unprecedented senses and skills, our R&D program is uniquely equipped to unveil new, detailed insights in the genomic, biologic and clinical nature of dermatologic diseases.

Under the wings of the Falcon R&D Program, a series of specific studies and projects is initiated, aimed at developing and introducing an array of diagnostic utilities, to provide physicians with the tools to optimize the clinical pathway of their patients.

These diagnostic utilities are all based on gene expression signatures.

Pipeline


In our R&D centered partnerships with clinicians and academia, entrepreneurial drive interacts with scientific
expertise to tackle unmet needs in personalized healthcare.
The Falcon R&D Program pipeline includes multiple study initiatives on dermatologic diseases,
such as Melanoma and cutaneous Squamous Cell Carcinoma.

 

The following table is subject to ongoing updates as the study initiatives evolve.

Falcon’s Study Initiatives

Merlin Study Initiative

The Merlin Study Initiative helps answering the question “Can this patient safely forgo a Sentinel Lymph Node Biopsy?”. At the core of this initiative is a proprietary algorithm, called the CP-GEP model. CP-GEP interrogates 8 genes of interest, directly correlated to risk of nodal metastasis, and integrates clinicopathologic variables (patient age and Breslow thickness) into the analysis. The model is able to predict a melanoma patient’s nodal metastatic risk without an invasive Sentinel Lymph Node Biopsy surgery. Ongoing extensive validation studies in the US and EU have confirmed that the test accurately stratifies low- and high-risk patients.

Watch here Merlin’s explanatory animation

Watch here the tumor board at WCM 2021

Peregrine Study Initiative

The Peregrine Study Initiative helps answering the question “Which patient is at high risk of disease recurrence?”. These patients may benefit from increased surveillance or early adjuvant therapy.
The initiative investigates clinical decision making by assessing individual risk profiles for recurrence, despite having a negative sentinel lymph node in patients with thin and intermediate thickness melanomas (Breslow thickness 0.8-4mm).

Kestrel Study Initiative

The Kestrel Study Initiative aims at investigating patients with early-stage melanoma at high risk of disease-related fatality.
Approximately 90% of all melanoma patients are diagnosed with an early-stage melanoma which is thin and has not spread to the lymph nodes at diagnosis. However, 41% of melanoma-related deaths occur among these early-stage patients that initially have a good prognosis. As current predictors are not sufficient to identify this specific patient group, the consortium will dedicate its research to find novel variables (e.g. genes and proteins in the primary tumor) and attempt to develop accurate biomarkers for this specific purpose.

Alopex Study Initiative

The Alopex Study Initiative aims at the discovery and validation of a model that identifies the cutaneous Squamous Cell Carcinoma patient at high risk of developing metastasis.
While most patients are cured by the excision of the primary tumor, 5% are at high risk of recurrence and even disease-specific death. These high-risk patients would benefit from intensive surveillance and additional treatment options. This collaboration has a unique starting point because the researchers have extensive experience and will work with the unique infrastructure of large routinely collected health care datasets of metastatic SCC patients.

Our Partners

The Falcon R&D Program aims to build an extensive, global network with research institutes. Not only for research and validation studies within the existing Study Initiatives but as well to broaden the scope of the Falcon Program by starting new Study Initiatives that would entail the whole spectrum of dermatology related clinical utilities. Our extensive development and validation network are sites in Australia, Europe and in the United States.

 

 

 

Falcon’s scientific references

 

The Falcon R&D Program aims to publish its scientific and clinical research as open access peer reviewed manuscripts, available for every stakeholder in the melanoma field. Below you can find references to scientific papers, together with abstracts and posters that have been presented at – and published by (international) melanoma related conferences.

Merlin

Validation of CP-GEP (Merlin Assay) for predicting sentinel lymph node metastasis in primary cutaneous melanoma patients: a U.S. cohort study.
Yousaf et al. 2021. International Journal of Dermatology. Link.

Validation of a clinicopathological and gene expression profile model for sentinel lymph node metastasis in primary cutaneous melanoma.
Mulder et al. 2020. British Journal of Dermatology. Link.

Deselecting melanoma patients for sentinel lymph node biopsy during COVID-19: clinical utility of tumor molecular profiling.
Meves & Eggermont 2020. Mayo Clin Proc Inn Qual Out. Link.

Primary cutaneous melanoma risk stratification using a clinicopathologic and gene expression model: a pilot study.
Arias-Mejias et al. 2020. International Journal of Dermatology. Link.

Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma.
Bellomo et al. 2020. JCO Precision Oncology. Link.

Peregrine

Identification of stage I/IIA melanoma patients at high risk for disease relapse using a clinicopathologic and gene expression model.
Eggermont et al. 2020. European Journal of Cancer. Link.

Kestrel

Kestrel Study Initiative has not yet published a peer-reviewed article.
Keep an eye on this website to follow the latest developments.

Alopex

Alopex Study Initiative has not yet published a peer-reviewed article.
Keep an eye on this website to follow the latest developments.

Merlin

Using the clinicopathologic and gene expression (CP-GEP) model to predict sentinel node status in patients with primary melanoma: a prospective cohort study during the COVID-19 pandemic.
Mulder et al. 2021. EADO Conference. Poster.

Independent validation study of CP-GEP model (Merlin Assay) to identify patients who can safely forgo sentinel lymph node biospy.
Johansson et al. 2021. EADO Conference. Poster.

The use of a clinicopathologic and gene expression model (Merlin Assay) to risk stratify cutaneous melanoma patients in clinical practice: A pilot study.

Bridges et al. 2020. ASDP Conference. Abstract.

A combined clinicopathologic and gene expression model (CP-GEP) identifies primary cutaneous melanoma patients who can safely forgo sentinel lymph node biopsy.
Meves et al. 2020. AAD Conference. Abstract.

Validation of a Model Combining Clinicopathologic Risk Factors and a Gene Expression Profile to Identify Primary Melanoma Patients Who Can Safely Forgo Sentinel Lymph Node Biopsy.
Yousaf et al. 2020. ESMO Conference. Abstract. Poster.

Validation of a ClinicoPathological and Gene Expression Profile (CP-GEP) model for sentinel lymph node metastasis in primary cutaneous melanoma.
Mulder et al. 2019. ESMO Conference. Abstract.Poster.

Stromal gene expression predicts sentinel lymph node metastasis of primary cutaneous melanoma.
Sominidi-Damodaran et al. 2019. EADO Conference.Abstract.Poster.

A molecular model to identify patients who can safely forgo sentinel lymph node biopsy in primary cutaneous melanoma.
Bellomo et al. 2019. CIM Conference. Abstract. Poster.

Peregrine

Using a clinicopathologic and gene expression (CP-GEP) model in a European cohort to identify stage II melanoma patients at high risk for disease relapse.
Mulder et al. 2021. EADO Conference. Poster.

Identification of stage IIA melanoma patients at high risk for disease relapse using a clinicopathologic and gene expression model.
Wever et al. 2020. ASCO Conference. Abstract.

Using a clinicopathologic and gene expression model to identify melanoma patients at high risk for disease relapse.
Eggermont et al. 2020. ASCO Conference. Abstract. Poster.

Kestrel

Kestrel Study Initiative has not yet published abstracts or posters.
Keep an eye on this website to follow the latest developments.

Alopex

Alopex Study Initiative has not yet published abstracts or posters.
Keep an eye on this website to follow the latest developments.

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