Molecular Testing in Melanoma 

Dermatologists understand the concern and danger patients face when biopsies reveal melanoma. Since almost 7,000 Americans are predicted to die from melanoma in 2020, and some therapeutic regimens for advanced disease are contingent upon molecular tumor markers, clinics must take an active role in accelerating the molecular testing process.

Dermatologists can benefit from a baseline understanding of molecular testing. By identifying why molecular tests are ordered, exploring the most common forms of testing, and examining the testing workflow, dermatologists can help to ensure their patients receive life-saving care.

Why are molecular tests ordered?

When a diagnosis of advanced melanoma occurs, molecular diagnostic testing is critical to revealing opportunities for targeted therapies and immunotherapies. Targeted therapies treat melanoma by inhibiting genetic driver mutations. One of the most commonly mutated genes in melanoma is BRAF, which affects about 50 percent of all melanoma cases. Mutations in the BRAF gene produce a protein that can cause cancerous cells to grow and divide. In addition, tumors with certain BRAF mutations are sensitive to targeted therapy with BRAF and MEK inhibitors, which is associated with prolonged survival. Another commonly mutated gene in melanoma is NRAS, which can also be targeted by MEK inhibitors.

Melanomas with mutations in the C-KIT gene are less common but can also be tested for. Typically, C-KIT melanomas occur on the palms, hands, feet, or mucosal areas like the mouth. Some targeted therapies, such as imatinib, can be utilized in tumors with C-KIT mutations.

Immunotherapy utilizes the body’s own immune system to treat melanoma tumors. A biomarker called tumor mutational burden has been associated with response to immunotherapies. Tumor mutational burden can be determined by certain types of molecular testing.

Molecular testing is recommended for at-risk patients with stage 3 and stage 4 metastatic melanoma. While stage 3 can suggest satellite tumors or multiple lymph nodes matted together, stage 4 indicates cancer has spread to other areas of the body, such as the liver, soft tissue, spinal cord, or lungs. A patient in either stage can expect surgery, targeted therapy and/or immunotherapy, and possible radiation treatment.

What are the most common forms of testing?

When testing detects cutaneous malignant melanoma in the early localized stage, patients have a five-year survival rate of 99 percent. However, a belated diagnosis that results in cancer spreading to regional or distant locations can reduce the five-year survival rate to as little as 25 percent.

Molecular testing is most commonly performed on a sample of the patient’s melanoma tumor. Testing procedures are often determined by what is covered by the patient’s insurance. Next-Generation Sequencing (NGS) performs full characterization and provides the most genetic information. This highly sensitive test can identify mutations in melanoma tumor tissue simultaneously in BRAF and hundreds of other genes, including NRAS and C-KIT. Some NGS tests can also measure tumor mutational burden, a biomarker for response to immunotherapy.

Real-time polymerase chain reaction (RT-PCR) is another form of molecular testing that detects the most common mutations (hot spot mutations) in a gene. While PCR testing specializes in low numbers of gene targets, it can offer faster turnaround time for results when only one or a few genes are of interest. NGS testing can simultaneously detect mutations across thousands of target regions. Either of these genetic tests is optimal for BRAF mutation analysis.

What is the molecular testing workflow?

Traditionally, oncologists handle molecular testing. However, dermatologists can speed up the process by requesting the tests from their dermatopathology lab partner, which should have protocols to manage and report mutation tests. Experienced full-service dermatopathology labs like PathologyWatch stay up to date on the latest molecular testing processes. In addition to managing tests for dermatology clinics, the academic-level dermatopathologists at PathologyWatch also manage testing for oncologists.

Once the laboratory makes the melanoma diagnosis, EMR integration is a reliable way to share fast and accurate results with the dermatologist, who is an integral part of the patient’s care team. After receiving the results, the dermatologist can refer the patient to an oncologist, who will start life-saving treatment based on the molecular testing results.

Though representing only 1 percent of all skin cancers, melanoma’s ability to spread to other parts of the body makes it highly lethal. As a dermatologist, knowing why molecular tests are ordered, understanding the different types of testing, and being aware of the testing workflow can help you get your patients the prompt treatment they require.

PathologyWatch Announces Locum Tenens Dermatopathology Services

Full-service lab PathologyWatch now provides remote, academic-level dermatopathology services to laboratories in need of temporary or long-term support.

Digital dermatopathology service provider PathologyWatch is now offering top-tier dermatopathology services to laboratories in need of temporary or long-term locum tenens support. Utilizing the advantages of digital pathology, PathologyWatch provides instant remote access to a workforce of academic-level dermatopathologists.

Commonly, a laboratory in need of locum tenens assistance is responsible for providing travel arrangements, lodging and per diem to attract qualified talent. Using an integrated digital pathology system, PathologyWatch eliminates costly overhead by offering a network of expert dermatopathologists available 24/7 for consultation. As a result, laboratories find a seamless transition to help them to continue running at full capacity.

“Providing locum tenens support to companies experiencing overflow due to staffing or seasonal variables is the next logical step for PathologyWatch,” says CEO and co-founder Dan Lambert. “Our locums tenens support is ideal for pathology labs and dermatology clinics that have a limited number of in-house dermatopathologists. The on-demand services require no minimum or advanced notice. When dermatopathologists have an influx of samples, have a life event, or even want to take a vacation, they can simply turn on the services for as long as they need them.”

In addition to a significant reduction in travel costs, PathologyWatch provides labs with 24/7 digital access to all pathology slides without purchasing a scanner. This also includes improved access to subspecialists and second opinions. Meanwhile, extensive insurance coverage means PathologyWatch can accommodate the majority of laboratory customers nationwide.

“Using PathologyWatch for locums coverage has given me access to high-quality dermatopathologists when I needed the coverage with ease and flexibility,” said Emily Green, dermatopathology lab director at Golden State Dermatology. “I highly recommend their services.”

For more information on PathologyWatch, please visit PathologyWatch.com. PathologyWatch follows all state and federal regulations. As such, the specific coverage arrangement may vary from state to state.

About PathologyWatch

PathologyWatch is the groundbreaking leader of digital dermatopathology services. Through these services, dermatology clinics, hospitals and laboratories can improve operational efficiency by speeding up workflow and enhance patient outcomes by utilizing the PathologyWatch expert professional team and partner laboratory services. This can facilitate best-in-class reads and, in some cases, enable additional revenue to the practice by in-housing pathology. With an intuitive and easy-to-implement digital pathology solution that includes access to top-tier dermatopathologists and a streamlined clinical workflow that interfaces directly into the EMR, PathologyWatch brilliantly combines state-of-the-art technology and clinical decision making to deliver unprecedented patient care.

3 Ways Digital Pathology Is Instrumental in the Shared Decision-Making Process

Sometimes, seeing is believing.

This is never more true than when discussing a treatment plan for a medical condition. “Communicating the importance of medical evidence and a balanced representation of options is the first step toward accelerating patient engagement in shared decision making,” concluded the groundbreaking discussion paper Communicating with Patients on Health Care Evidence.

This research found that 80 percent of patients want their provider to tell them the full truth about their diagnosis even though it may be unpleasant. Around 70 percent of people surveyed want their provider to share the risks associated with each option. But how can a healthcare provider share clear, definitive information for their patients who are often unfamiliar with terminology and find it difficult to fully comprehend the ramifications of the diagnosis? 

The answer is simple: Provide a visual aid. 

The aforementioned study published by the Institute of Medicine of the National Academies examined the effects of using visual aids as part of the patient’s decision-making on treatment plan options. Researchers found that when patients are given decision aids—such as educational booklets, DVDs, or interactive tools—to help them make treatment choices, they are more knowledgeable and satisfied with their care. 

If visual aids prove beneficial for patients to better understand their diagnoses and the necessary treatment plan, then let’s discuss the three exciting ways digital pathology acts as an effective decision aid for patient care and heightens the quality of care delivered. 

1. Encourages Patient Engagement

At PathologyWatch, we utilize the collaborative capabilities of digital technology as it provides full access to a patient’s test slide through our EMR. And that information can also be shared with a patient to assist in the decision-making process for designing a treatment plan. 

In many cases, patients are better able to understand their diagnoses when they can see the pathology associated with their cases. This isn’t just about delivering information to a patient. Instead, as our dermatology clients attest, it invites a personal conversation that centers around a patient’s concerns and goals for treatment. 

Typically practiced in breast cancer cases, for example, shared decision-making (SDM) provides a collaborative strategy for a patient and the healthcare provider to discuss medical options. Most consumers (95 percent) believe it is important that doctors tell them about the results of medical research when making treatment decisions. By pairing the patient’s values and priorities with the physician’s expertise, both parties can talk about the best possible option.

2. Provides Faster Results

Experts predict that the global number of new cancer cases will rise by 70 percent over the next two decades. This means pathology labs will need to find ways to accommodate the increase in demand through cost-saving efficiency and diagnoses. 

“Digitizing your workflow is not simply a question of upgrading your lab’s hardware and IT,” says Ivo Van den Berghe, MD. “It’s also about rethinking your ways of working. . . . Digital pathology replaces the subjective nature of manual slide inspection under the microscope.”

Digital transformation also creates more efficiency. “In the old situation, a lab assistant would have to manually sort and archive 300 tissue samples each day,” Van den Berghe says. “Now the samples are sorted and archived automatically. This saves our lab assistants a lot of time.” Such expediency means doctors can meet with their patients sooner, armed with visual test results, and discuss more timely treatment plan options that can improve the recovery rate. 

3. Provides a Comprehensive Perspective

In cases where the diagnosis involves a rare condition, digital pathology can make it possible for doctors to tap into expertise available throughout the world for a comprehensive understanding of an irregular case. “We’re connecting with laboratories worldwide to get a better understanding of rare tumors and how to treat them,” Van den Berghe says. “Digital pathology enhances clinical confidence in our findings by delivering the right result the first time.”

Patients trust their doctor to deliver accurate results. With digital pathology, they can get their results quickly, participate in shared medical decisions, and potentially benefit from a more comprehensive perspective of their diagnosis and ideal treatment options.

Better Communication with Your Dermatopathology Laboratory Equals Better Results

As a dermatologist, you rely on your lab partner to provide correct diagnoses to ensure your patients receive the highest level of care. However, since communication errors are a major factor in up to 70 percent of adverse events, it’s easy to see how better communication with your dermatopathology laboratory can lead to better results.

Producing accurate results is a team effort. By identifying the information required for a definitive diagnosis, developing a communicative relationship, and enhancing communication through technology, you can help your dermatopathology lab consistently produce more valuable reports. 

Facilitating Definitive Diagnoses

When it comes to complicated diagnoses (such as rashes/eruptions), it’s safe to say dermatologists get out of it as much as they put into it. In cases like these, the value of the report you receive from the lab sometimes reflects the amount and quality of clinical information you share with the dermatopathologist.

For instance, including your differential diagnosis in the requisition form can help steer the dermatopathologist in the right direction. This is particularly helpful when it comes to the diagnosis of inflammatory skin diseases. The histological findings may be subtle, and comprehensive clinical information, including photos, may be needed to arrive at the most accurate diagnosis.  

By providing your dermatopathologist with clinical features, you can help ensure they have the required data to make a definitive diagnosis.

Relationships of Communication

When a dermatologist receives a report that is not definitive, it could be the result of the dermatopathologist not fully understanding the clinical scenario. In these cases, the dermatologist should be proactive and communicate with the dermatopathologist, providing any additional details for a more definitive diagnosis. For example, relevant information for an eruption may include the distribution, duration, symptoms, extent, and color. The dermatopathologist should also reach out to the dermatologist for more information when needed.

Meanwhile, dermatologists who value turnaround time and accurate results should make improving the relationship with the lab a priority. A survey of dermatopathologists showed that diagnoses were delayed due to lack of clinical information, as 45 percent of respondents spend more than 30 minutes a day tracking down clinical information that was not present on the order form. By voluntarily providing information upfront, following up as needed, and building relationships based on communication, you can help your dermatopathologist improve the quality of the lab results. 

Technology-Enhanced Information 

Digital tools can enhance laboratory reporting and enable clinicians to better correlate findings. For example, an EMR interface can simplify the transfer of data between your clinic and the lab. This can reduce the chances of errors by replacing handwriting and carbon copies. In clinics where handwritten requisition forms are used, digital tools provided by PathologyWatch enhance clinic flexibility by providing various reporting options. 

PathologyWatch also supports clients interested in enhanced EMR reporting options. Where available, these EMR interfaces can provide the dermatopathologist with valuable clinical information, including clinical photos, visit notes, and the history of present illness to the laboratory. In addition, PathologyWatch is able to deliver results that speed up dermatologist report review and sign-off within their clinic. 

By providing clinical features, taking a proactive role in communicating, and considering technology options to support your communication, you can experience better communication with your dermatopathology laboratory to produce better results.

Critical Value in Dermatopathology—Where Time and Communication Are Essential

Critical values are defined as “laboratory results that indicate a life-threatening situation for the patient.” Because of their demanding nature, the appropriate healthcare professional must be notified urgently of a critical value. 

In the field of dermatopathology, the College of American Pathologists defines a critical value as a critical diagnosis such as “a medical condition that is clinically unusual or unforeseen and should be addressed at some point in the patient’s course.”

All laboratories, including dermatopathology labs, are required to exercise effective communication when it comes to reporting critical diagnoses and must have a written protocol in place. This is in accordance with laboratory regulations outlined by CLIA (Clinical Laboratory Improvement Amendments; CLIA ’88) and the Joint Commission (TJC) National Safety Goals.

Dermatology clinics should understand what qualifies as a critical or a significant unexpected diagnosis. By examining how labs identify and manage critical diagnoses, defining the referring provider/lab partnership, and understanding how results are shared, we can expedite treatment and improve patient care.

Management of Critical Diagnosis in the Lab

Immediate and decisive action is required in the dermatopathology lab to identify and report critical diagnoses to the dermatologist as soon as possible. Every dermatopathology laboratory should have a written protocol outlining the diagnoses that are considered critical. In most instances, a new diagnosis of invasive melanoma is considered a critical diagnosis, as well as a life-threatening diagnosis such as staphylococcal scalded skin syndrome, graft versus host disease, or toxic epidermal necrolysis. Unalarming in appearance, each of these skin disorders could lead to serious health complications if not treated quickly. 

Once identified as critical or significant, the laboratory is responsible for documenting how and when the results are communicated with the dermatology clinic. If the diagnosis is shared over the phone, there should be a record of who made and received the call. In addition to ensuring the clinic accepts and understands the results, the lab keeps a record to comply with existing laboratory regulations.

The Referring Provider/Lab Partnership

When a clinic and laboratory form a new partnership, the dermatologist and lab open communication lines to clarify the types of results they define as urgent or critical.

Though 75 percent of laboratories have a written policy for handling critical and significant unexpected diagnoses, clinics need to ensure their lab’s processes meet the needs of patients and practices (for instance, if a dermatologist establishes that he or she wants a notification for melanoma in-situ as well as invasive melanoma, or for unexpected cases of Tinea spp). By communicating regularly regarding cases, mutual trust will develop over time between the lab and the clinic.

Sharing Urgent Results

The most crucial step in the critical diagnosis process comes when the dermatologist shares the results with patients and points them towards treatment. The urgency is real, as the rate of survival decreases 5 percent for patients with stage I melanoma treated between 30 and 59 days compared with those treated in the first 30 days after diagnosis. 

To ensure fast and precise action, it is helpful when labs share critical values directly to the EMR in addition to a phone call. Full-service dermpath labs like PathologyWatch transfer results and digital images electronically, enabling clinics to correlate with dermatopathologists instantly. At the same time, accessing the diagnosis in the EMR makes it easy for dermatologists to quickly share the results with patients on a tablet or laptop, reducing worrisome waiting periods.

Whenever a dermatology clinic sends a batch of request sheets to the lab, there are chances for revealing critical diagnoses. By clarifying what constitutes a critical value, defining the referring physician/lab partnership, and examining the best way to share results, you can increase optimal treatment and recovery for patients.