Based on technology from SkylineDx, the test
aims to aid treatment decisions for patients with the deadliest
form of skin cancer
Patients classified as low-risk by MelaNodal
Predict are shown to have survival rate of over 90
percent
SECAUCUS, N.J., and SAN DIEGO, Feb. 13,
2024 /PRNewswire/ -- Quest Diagnostics (NYSE:
DGX), the nation's leading provider of diagnostic information
services, today announced the launch of MelaNodal Predict™, a
highly advanced predictive gene expression test to help personalize
treatment decisions for patients with melanoma, the deadliest form
of skin cancer and one of the most common cancers in the United States.1 Dermatologists
and other providers nationwide may begin ordering the test today
from Quest Diagnostics, as well as through Dermpath
Diagnostics, Quest's subspecialty pathology business.
MelaNodal Predict is a lab-developed test validated by Quest
Diagnostics and based on technology developed by SkylineDx, an
oncology biotechnology company, alongside Mayo Clinic. The
technology utilizes a combination analysis of patient age and tumor
thickness with advanced gene expression profiling technology.
MelaNodal Predict examines a patient's original diagnostic tumor
biopsy and applies an algorithm to help providers identify patients
with a low or high risk of nodal metastasis (melanoma that has
spread to the lymph nodes).
This insight may help providers identify patients that could,
with less risk, avoid a potentially unnecessary, expensive and
invasive surgery called a sentinel lymph node biopsy (SLNB). If the
algorithm classifies a patient as low risk, they may be able to
choose to forgo the procedure. More than 8 in 10 patients who have
an SLNB are negative for nodal metastasis, based on post-surgical
analysis.2
"Melanoma test services are an important component of our broad
portfolio of advanced oncology tests," said Kristie Dolan, Senior Vice President and General
Manager of Oncology at Quest Diagnostics. "By leveraging our scale,
we can provide MelaNodal Predict to patients and treating
physicians across the country to support clinical decision making.
The MelaNodal Predict test's results will help physicians identify
their patient's risk of metastasis to assist in individualizing
surgical decisions and patient management plans."
By reducing SLNB interventions, providers who utilize the test
may be able to more effectively use healthcare resources and manage
patient risk. It is estimated that patients who receive an SLNB
have a greater than 10% risk of surgery-related complications
including bleeding, infection and limb swelling.3 The
test also provides insights on a patient's long-term outcome, as
patients with a low-risk result have reported better survival
rates. All studies of the algorithm utilized have reported minimal
follow up after five years,4 and recent data from 6 US
institutions shows that patients the algorithm classified as low
risk have a survival rate of more than 90 percent.5
"This relationship between Quest and SkylineDx is a testament to
the transformative impact that innovative collaborations can have
in healthcare. SkylineDx's expertise in molecular diagnostics,
coupled with Dermpath Diagnostics' leadership in dermatopathology,
has elevated MelaNodal Predict to a new standard in personalized
melanoma care," said Dharminder
Chahal, CEO of SkylineDx. "Working with Quest Diagnostics
will help us ensure we can continue to advance the field of
molecular diagnostics and broaden access to our innovations.
Together, we hope to make a meaningful impact on the lives of
individuals impacted by this disease."
This collaboration aims to combine SkylineDx's innovative
technology with Quest's expertise and national scale in
the United States, which includes
broad electronic health record connectivity and health plan
relationships and over 400 Quest, Dermpath, AmeriPath, and
PhenoPath pathologists. A leader in advanced oncology diagnostics,
Quest specializes in testing for inherited genetic disorders and
tumor sequencing for colorectal and other cancers. The pathology
businesses of Quest Diagnostics deliver subspecialty expertise for
health systems and other providers in the
United States and overseas.
About SkylineDx
SkylineDx is a biotechnology company
focused on research and development of molecular diagnostics in
oncology and inflammatory diseases. 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 predicting a patient's
response to treatment. Based on test results, healthcare
professionals can tailor the treatment approach to the individual
patient. SkylineDx is headquartered in Rotterdam, the Netherlands, complemented by a
U.S. base of operations and a CAP/CLIA certified laboratory in
San Diego, California, USA. To
learn more about SkylineDx, please visit www.skylinedx.com.
About Quest Diagnostics
Quest Diagnostics empowers
people to take action to improve health outcomes. Derived from the
world's largest database of clinical lab results, our diagnostic
insights reveal new avenues to identify and treat disease, inspire
healthy behaviors and improve health care management. Quest
annually serves one in three adult Americans and half the
physicians and hospitals in the United
States, and our nearly 50,000 employees understand that, in
the right hands and with the right context, our diagnostic insights
can inspire actions that transform lives.
www.QuestDiagnostics.com.
1 Melanoma Skin Cancer Statistics | American
Cancer Society
2 Stetkevich SA, Simman R. Redesigning Sentinel Lymph
Node Biopsy Guidelines in Melanoma Cases. Eplasty. 2023
Feb 3;23:e8. PMID: 36817365; PMCID:
PMC9912052.
3 Wilke LG, McCall LM, Posther KE, Whitworth PW,
Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK,
Herndon JE 2nd, Giuliano AE. Surgical complications associated with
sentinel lymph node biopsy: results from a prospective
international cooperative group trial. Ann Surg Oncol. 2006
Apr;13(4):491-500. doi: 10.1245/ASO.2006.05.013. Epub 2006
Mar 2. PMID: 16514477.
4 Amaral T, Sinnberg T, Chatziioannou E, et al.
Identification of stage I/II melanoma patients at high risk for
recurrence using a model combining clinicopathologic factors with
gene expression profiling (CP-GEP). Eur J Cancer. 2023;182:155-162.
doi:10.1016/j.ejca.2022.12.021
5 Multicenter US Study Reveals CP-GEP's Profound
Impact on Stratifying Melanoma Patients for Long-Term Survival -
SkylineDx
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SOURCE Quest Diagnostics