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Ushering in Gene Signature-Based Diagnostic Testing

Ushering in Gene Signature-Based Diagnostic Testing

Dharminder Chahal, SkylineDx | Healthcare Tech Outlook | Top  Oncology Solutions CompaniesDharminder Chahal, Co-Founder and CEO, SkylineDx
SkylineDx, a leading molecular diagnostics company, is on a mission to turn the tide of one-size-fits-all cancer treatment with its innovative gene signature-based diagnostic tests. Not only does it assists healthcare professionals to create personalized treatment protocols, but it also improves patients’ quality of life by enabling them to benefit from insights driven at the genomic level of their disease.

The diagnostic products from SkylineDx help medical professionals identify the disease characteristics and customize the treatment strategy based on the patient’s profile. Patients who receive individualized care are less likely to suffer the adverse effects of under- or over-treatment, lowering the extent of complications and the need for hospitalization and medication.

SkylineDx started its journey in hematology. Its CLIA-validated and CE-marked clinical test, SKY92, can measure the activity of 92 cancer genesto determine the prognosis of multiple myeloma. Today, its portfolio is highly diversified to cater to different oncology branches. One, in particular, is skin cancer.

SkylineDx’ Falcon R&D program is a significant step in that direction for effective diagnosis and treatment of melanoma—an aggressive type of skin cancer. The program borrows its name from the bird, a highly intelligent creature with exceptional sensing abilities. Mimicking that intelligence, Falcon R&D offers physicians the tools to unveil new and detailed insights into the genomic, biological, and clinical nature of melanoma, which can then be used to optimize the clinical pathways of their patients.

SkylineDx has also developed the CE-IVD Merlin test kit that identifies melanoma patients who can forgo sentinel lymph node biopsy (SLNB) surgery, a procedure used to determine the metastatic spread of cancer for staging purposes. In approximately 80 percent of patients, the invasive biopsy comes back negative for metastasis. Merlin test provides a more personalized insight into the metastatic propensity of the tumor, identifying patients with a low-risk tumor that can avoid the surgery. The test accurately stratifies low- and high-risk patients and could lower surgery-related complications by 59 percent.

“We collaborated with the Mayo Clinic to bring the Merlin test into clinical practice. Today, the test comes under Medicare coverage, which has helped it gain more traction as an innovative molecular test,” says Dharminder Chahal, co-founder and CEO of SkylineDx.

Three other tests are currently in the development phase, including one focused on squamous cell carcinoma—the second most common form of skin cancer.

  • The diagnostic products from SkylineDx help medical professionals identify the disease type and customize the treatment strategy based on the patient’s response


The global team of experts at SkylineDx consistently collaborates with caregivers to translate their research in personalized medicine into clinical practice. Working across different time zones and locations, the team demonstrates its proficiency in clinical trial development and execution as well as product development.

Through its persistent efforts, SkylineDx is determined to revolutionize cancer diagnostics and treatment practices that have traditionally relied on standardized approaches. The company is dedicated to ushering in a new era of genetic testing and advancing the effectiveness of personalized cancer treatments.

 Top 10 Oncology Solutions Companies – 2023

Company
SkylineDx

Management
Dharminder Chahal, Co-Founder and CEO, SkylineDx

Description
SkylineDx, a leading molecular diagnostics company, is on a mission to turn the tide of one-size-fits-all cancer treatment with its innovative gene signature-based diagnostic tests. Not only does it assists healthcare professionals create personalized treatment protocol, but it also improves patients’ quality of life by enabling them to benefit from insights driven at the genomic level of their disease.

SkylineDx News

Independent European data on CP-GEP model in Stratifying Melanoma Patients for Long Term Survival

ROTTERDAM - SkylineDx is pleased to announce two forthcoming scientific publications at the European Association for Dermato-Oncology congress, April 4-6, 2024. These publications show Merlin test's (CP-GEP model) ability to identify early-stage cutaneous melanoma patients at high risk for relapse.
The first is a study led by researchers from Denmark, Weitemeyer, et al, that examined over 400 patients who underwent a sentinel lymph node biopsy (SLNB) between 2010 and 20151. All the biopsies were defined as negative for metastasis. The CP-GEP model was applied on the prospectively collected, archived tumor specimens and its outcome correlated with the patients' clinical data for 5 years following diagnosis (for both recurrence free survival and overall survival). The findings indicate that the model effectively stratifies node-negative patients in two groups: patients at low – and high risk for disease progression. In the high-risk group, 17.2% experienced a recurrence of the disease in the 5-year following diagnosis compared to 8% in the low-risk group.
While a nodal assessment by means of the SLNB surgery remains the gold standard for clinical staging of cutaneous melanoma, not all eligible patients might undergo this invasive procedure. Node biopsies in the head and neck location may be challenging due to the regional course of nerves and lymphatic drainage2. The second study, led by Dr. Amaral from University of Tuebingen, Germany, assessed the performance of the CP-GEP model in a group of patients that did not undergo the SLNB procedure. More specifically, she focusses on a subgroup of melanoma patients with a primary tumor in the head and neck region. CP-GEP showed to be able to identify patients with a high risk for recurrence in this independent dataset. The authors concluded that the model demonstrates potential to risk stratify patients with early-stage melanoma3.
"Both studies provide promising insights into CP-GEP's capacity to stratify patients based on their risk for disease progression and its potential value to support treatment and surveillance strategies for early melanomas." says Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx .