SkylineDx confirms positive results first independent validation skin cancer test

ROTTERDAM (the Netherlands) and SAN DIEGO (US), September 30, 2019: SkylineDx announced, during the European Society for Medical Oncology congress (Barcelona, EU), that it successfully validated the performance of their skin cancer (melanoma) diagnostic test on the first, independent, European dataset. This melanoma test combines genetic information from a patient’s tumor cells (taken during a diagnostic biopsy) with tumor – and patient specific characteristics. Based on this unique combination, the test is able to accurately predict the risk of having metastasis present in the lymph nodes without a patient having to undergo a surgery to remove (part of the) lymph nodes. The discovery came from an US patient population and remains robust in the Dutch validation population, saving 41% of patients an unnecessary surgical intervention [2].

These positive results follow last week’s announcement of launching a pilot study to evaluate and optimize the diagnostic services in clinical practice with a renowned US hospital in Q4 2019 and the start of a national trial in the US in 2020 [3]. “I am always anxious going into validation. If you optimize the performance of a test too much on the initial dataset, it will only work in that dataset and fails in an independent dataset”, says Dharminder Chahal, CEO SkylineDx. “That we may present these positive results today during this major conference, is fantastic news for our team and gives everyone the needed energy and enthusiasm to continue the developments in our Falcon R&D Program to get this test from bench to bedside as quickly as possible”.

About SkylineDx

SkylineDx is a high-tech commercial-stage biotech company headquartered in Rotterdam, the Netherlands and a commercial office and CAP/CLIA certified laboratory in San Diego, California, USA. The company uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility. With the focus on diagnostics, SkylineDx assists healthcare professionals in accurately determining the type or status of the disease or to predict a patient’s response to a specific treatment. Based on the test results, healthcare professionals can tailor the treatment to the individual patient. To learn more, please visit www.skylinedx.com.

Footnotes

1. Link to press release on website SkylineDx (click here).

2. Mulder & Dwarkasing et al., 2019. ESMO Poster Discussion #1325 ID3615. Presentation Monday September 30, 2019: 12-1PM Poster Area (Hall 4) at ESMO in Barcelona, Spain (EU).  

3. SkylineDx and Mayo Clinic collaborate on implementing skin cancer test in clinical practice (click here)