PR85281

ROTTERDAM, Netherlands and SAN DIEGO, August 26, 2020, /PRNewswire=KYODO JBN/--

SkylineDx signed a collaboration agreement with a multi-disciplinary clinical

consortium in the Netherlands that designed a trial to implement a diagnostic

innovation to manage continuity of care delivery when resources are under

pressure due to COVID. The diagnostic tool, Merlin Assay, identifies melanoma

(skin cancer) patients for whom postponing sentinel lymph node biopsy (SLNB)

surgery would be at minimal risk, allowing physicians to better triage care and

allocate resources. Around 80% of melanoma patients that undergo an SLNB

surgery to check for metastases, have no detectable disease spread, making the

surgery redundant. The Merlin Assay uses characteristics from the primary tumor

and the patient's age to calculate if a patient's risk of having metastases is

so low that the surgery can be safely avoided. Reducing up to 42% of these

surgeries [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220172/ ]

[https://oncologypro.esmo.org/meeting-resources/esmo-2019-congress/Validation-of

-a-Clinicopathological-and-Gene-Expression-Profile-CP-GEP-Model-for-Sentinel-Lym

ph-Node-Metastasis-in-Primary-Cutaneous-Melanoma ] , the Merlin Assay enables

hospitals to efficiently direct their surgical resources to patients with the

highest need, and in case of metastases, prioritize immediate steps on their

care path. The consortium consists of 8 Dutch institutes and is led by the

Erasmus MC, University Medical Center Rotterdam (EMC).

"Reducing the backlog of regular care and maintaining it, is of utmost

importance while we are preparing for a possible new COVID peak", comments

Prof. Dr. Kees Verhoef, Head of Oncology – and Gastrointestinal Surgery at EMC.

"Tools that better direct the use of healthcare resources, will make us better

equipped to provide adequate cancer care for individual patients at the moment

they need it".

A recent US case study from the Mayo Clinic described the clinical pathway of a

melanoma patient that was referred for the SLNB surgery. It took 21 days of

extensive use of hospital resources, medical specialists and laboratory tests,

including a 90-minute surgery under general anesthetics, to arrive at an SLNB

result which turned out to be negative for metastasis.  For the same patient,

the Merlin Assay, correctly identified the low risk nature of the patient's

melanoma after just a few days

[https://mcpiqojournal.org/article/S2542-4548(20)30101-6/pdf ]. It is an

illustrative example of how the diagnostic innovation could impact the patient

pathway. The Dutch trial will capture this information in real world setting.

"Better allocation of resources and a faster turnaround time are not the only

benefits, using the Merlin Assay in routine clinical practice," continues Dr.

Dirk Grunhagen, Oncological Surgeon at EMC. "The overall complication rate

associated with the surgery is between 5-10%. The Merlin Assay may save the

low-risk patient group surgical complications and the subsequent care needed."

"It has been a proud moment to experience how different stakeholders can come

together and be innovative in designing and implementing solutions when it is

most needed," comments Dharminder Chahal, CEO of SkylineDx that developed the

Merlin Assay. "We are very excited that we were able to contribute by accelerating

the access to our diagnostic innovation. With the start of this study, another

important step towards personalizing cancer treatment has been taken."

About Merlin

The Merlin assay uses the CP-GEP model, a powerful algorithm that calculates

the risk of metastasis in a patient's sentinel lymph nodes. The model is able

to calculate risk on an individual basis through a combination analysis of 8

genes from the patient's primary tumor, the tumor thickness and the patient's

age. The model has been previously published in JCO Precision Oncology

[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220172/ ] and validated by the

Erasmus MC, University Medical Center Rotterdam

[https://oncologypro.esmo.org/meeting-resources/esmo-2019-congress/Validation-of

-a-Clinicopathological-and-Gene-Expression-Profile-CP-GEP-Model-for-Sentinel-Lym

ph-Node-Metastasis-in-Primary-Cutaneous-Melanoma ]. Further clinical research

and validation studies on the predictive use of the CP-GEP model is the main

focus of the Merlin Study Initiative, developed under the wings of the Falcon

R&D Program [https://falconprogram.com/ ].

About SkylineDx

SkylineDx [https://skylinedx.com/ ] is a biotechnology company, mainly focused

on research & development of molecular diagnostics in oncology. The company is

headquartered in Rotterdam (the Netherlands) and complemented with a field

medical and scientific affairs team in the US and a CAP/CLIA certified

laboratory in San Diego (California). SkylineDx uses its expertise to bridge

the gap between academically discovered gene expression signatures and

commercially available diagnostic products with high clinical utility,

assisting healthcare professionals in accurately determining the type or status

of disease or predict a patient's response to treatment. Based on test results,

healthcare professionals can tailor the treatment approach to the individual patient.

SOURCE: SkylineDx