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05-19-2018, 05:35 AM
Advanced Cancer Diagnostics Reduce Frequency of Misdiagnoses: Interview with Precipio CEO Ilan Danieli
https://www.medgadget.com/wp-content/uploads/2018/05/logo-2-300x127.pngAccording to 2010-2012 data from the National Cancer Institute (NCI), 40% of men and women will be diagnosed with cancer in their lifetime. In all its forms, cancer is known to be a clinically and emotionally challenging disease to manage. Despite the fact that each year 455 men and women per 100,000 patients are diagnosed with cancer (NCI, 2008-2012 data), 1 in 5 cancer patients are still misdiagnosed, further exacerbating the challenges of treatment for clinicians, patients, and their families.
Founded in 2011, Precipio Diagnostics (http://www.precipiodx.com/)*out of New Haven, Connecticut is a reference laboratory using advanced diagnostics and personalized medicine to reduce the prevalence of cancer misdiagnosis. Today, Precipio reports a 99% accuracy rate in correctly diagnosing cancer patients through the company’s unique combination of offerings.
Precipio’s diagnostic services include laboratory testing and clinical review through partnerships with some of the nation’s leading medical institutions, including the Yale School of Medicine. In addition to its services, Precipio is also developing and commercializing products in line with its diagnostic services. Last month, the company filed a provisional patent for a non-invasive cell capture device for gynecological cancer detection.
To learn more about Precipio’s offerings and vision for improving cancer diagnosis, Medgadget had a chance to speak with the company’s Founder and CEO, Ilan Danieli.
Michael Batista, Medgadget:*What are the causes of cancer misdiagnosis and what are the repercussions*when a patient is misdiagnosed?
https://www.medgadget.com/wp-content/uploads/2018/05/Danieli.jpgIlan Danieli:*There are many reasons a patient can be misdiagnosed; we believe one of the key causes of misdiagnosis is the lack of subspecialized expertise of the diagnosing pathologist. As the complexity of cancer continues to increase, the ability to correctly diagnose a patient is largely driven by the pathologist’s experience and focus. Pathology is largely a matter of pattern recognition; experience and expertise in being able to review the various components of the case (biopsy slides, clinical information, patient history); and putting together the picture to arrive at the right diagnosis. This requires significant training and the development of subspecialist expertise. Conversely, we see the pathology industry moving in the opposite direction, with pathologists functioning more as generalists, being asked to do more, review a broader range of patient types, with less training.
The repercussions of misdiagnosis can be lethal. The diagnosis sets the path for the entire treatment course the patient and their oncologist will embark on as they begin their battle against the cancer. A wrong diagnosis will send even the best and brightest of oncologists down the wrong path. To be clear, when we say misdiagnosis, the bulk of the mistakes are incorrect classification of the disease. A false positive/negative is less frequent, although sadly, it does happen, and we have seen many such cases. Misdiagnosis can result in placing the patient on the wrong treatment, which can lead to disease progression and further harm to the patient. It’s important to keep in mind that cancer treatment involves chemotherapy, which uses highly toxic drugs that are put into the patient’s body with the intent of attacking the cancer cells. With various treatments designed to attack different types of cells, administering the wrong chemotherapy drug can be catastrophic.
Another element of the diagnostic process is determining the prognosis (severity) of the disease. Many cancers are defined both by stage, as well as how aggressive they are. Less-aggressive cancers are treated in a different manner than more-aggressive cancers; the decision on how aggressively to treat the patient is based on the pathologist’s determination of the disease prognosis.
Medgadget:*What are the industry standards for diagnosing cancer today which lead to these*surprisingly high misdiagnosis rates?
Danieli:*It’s important to understand that the diagnostic process includes two elements. The first is the laboratory work, often referred to as the “technical component,” where the biopsy is received and various tests are run on it. This includes chemical staining, laser-based analysis, chromosome evaluation, and many other tests. The industry standards are governed by Clinical Laboratory Improvement Amendments (CLIA), which mandate the method in which a laboratory test is developed and validated, and the ability to reproduce consistent results. While there are guidelines in terms of which tests are customarily ordered based on the clinical information and the type of biopsy, these tests are laboratory-developed (termed LDTs) and each laboratory may have different protocols for which tests are run and how they are set up. Many of the characteristics of the laboratory output are also driven by the medical director’s preferences and expertise. These factors can result in various degrees of variability in the output a laboratory produces.
The second element of the diagnostic process is the professional interpretation. In this step, the pathologist receives all the laboratory “outputs,” reviews all the information, and arrives at a diagnosis. The ability to arrive at the correct diagnosis is largely driven by the pathologist’s training, experience and expertise. If the pattern presenting in the slides and other materials is familiar to the pathologist, either through training or having seen it before, then there is a higher likelihood that they will arrive at the correct diagnosis. In order to qualify to render a diagnosis, the physician must be a board-certified pathologist. However, while there are many subspecialist certifications that provide a higher level of training and subspecialized expertise, there is no regulatory requirement for pathologists to complete these subspecialized training programs in order to diagnose such cases.
For example, we specialize in hematopathology (cancers of the blood system: leukemia, lymphoma, etc.), one of the most complex types of cancers to diagnose. While there is a board certification as a subspecialist hematopathologist, many pathologists with an anatomic pathology certification, who don’t have that board certification, still diagnose blood-related cancers.
Medgadget:*Why did you and your team at Precipio think you could improve upon the industry standards?
Danieli:*We observed a growing gap between the need for subspecialized expertise required to reach the correct diagnosis and what the industry was providing. We recognized that one of the only sources of subspecialized expertise was within premier academic institutions; however, the only patients who were benefitting from that expertise,
https://www.medgadget.com/wp-content/uploads/2018/05/logo-2-300x127.pngAccording to 2010-2012 data from the National Cancer Institute (NCI), 40% of men and women will be diagnosed with cancer in their lifetime. In all its forms, cancer is known to be a clinically and emotionally challenging disease to manage. Despite the fact that each year 455 men and women per 100,000 patients are diagnosed with cancer (NCI, 2008-2012 data), 1 in 5 cancer patients are still misdiagnosed, further exacerbating the challenges of treatment for clinicians, patients, and their families.
Founded in 2011, Precipio Diagnostics (http://www.precipiodx.com/)*out of New Haven, Connecticut is a reference laboratory using advanced diagnostics and personalized medicine to reduce the prevalence of cancer misdiagnosis. Today, Precipio reports a 99% accuracy rate in correctly diagnosing cancer patients through the company’s unique combination of offerings.
Precipio’s diagnostic services include laboratory testing and clinical review through partnerships with some of the nation’s leading medical institutions, including the Yale School of Medicine. In addition to its services, Precipio is also developing and commercializing products in line with its diagnostic services. Last month, the company filed a provisional patent for a non-invasive cell capture device for gynecological cancer detection.
To learn more about Precipio’s offerings and vision for improving cancer diagnosis, Medgadget had a chance to speak with the company’s Founder and CEO, Ilan Danieli.
Michael Batista, Medgadget:*What are the causes of cancer misdiagnosis and what are the repercussions*when a patient is misdiagnosed?
https://www.medgadget.com/wp-content/uploads/2018/05/Danieli.jpgIlan Danieli:*There are many reasons a patient can be misdiagnosed; we believe one of the key causes of misdiagnosis is the lack of subspecialized expertise of the diagnosing pathologist. As the complexity of cancer continues to increase, the ability to correctly diagnose a patient is largely driven by the pathologist’s experience and focus. Pathology is largely a matter of pattern recognition; experience and expertise in being able to review the various components of the case (biopsy slides, clinical information, patient history); and putting together the picture to arrive at the right diagnosis. This requires significant training and the development of subspecialist expertise. Conversely, we see the pathology industry moving in the opposite direction, with pathologists functioning more as generalists, being asked to do more, review a broader range of patient types, with less training.
The repercussions of misdiagnosis can be lethal. The diagnosis sets the path for the entire treatment course the patient and their oncologist will embark on as they begin their battle against the cancer. A wrong diagnosis will send even the best and brightest of oncologists down the wrong path. To be clear, when we say misdiagnosis, the bulk of the mistakes are incorrect classification of the disease. A false positive/negative is less frequent, although sadly, it does happen, and we have seen many such cases. Misdiagnosis can result in placing the patient on the wrong treatment, which can lead to disease progression and further harm to the patient. It’s important to keep in mind that cancer treatment involves chemotherapy, which uses highly toxic drugs that are put into the patient’s body with the intent of attacking the cancer cells. With various treatments designed to attack different types of cells, administering the wrong chemotherapy drug can be catastrophic.
Another element of the diagnostic process is determining the prognosis (severity) of the disease. Many cancers are defined both by stage, as well as how aggressive they are. Less-aggressive cancers are treated in a different manner than more-aggressive cancers; the decision on how aggressively to treat the patient is based on the pathologist’s determination of the disease prognosis.
Medgadget:*What are the industry standards for diagnosing cancer today which lead to these*surprisingly high misdiagnosis rates?
Danieli:*It’s important to understand that the diagnostic process includes two elements. The first is the laboratory work, often referred to as the “technical component,” where the biopsy is received and various tests are run on it. This includes chemical staining, laser-based analysis, chromosome evaluation, and many other tests. The industry standards are governed by Clinical Laboratory Improvement Amendments (CLIA), which mandate the method in which a laboratory test is developed and validated, and the ability to reproduce consistent results. While there are guidelines in terms of which tests are customarily ordered based on the clinical information and the type of biopsy, these tests are laboratory-developed (termed LDTs) and each laboratory may have different protocols for which tests are run and how they are set up. Many of the characteristics of the laboratory output are also driven by the medical director’s preferences and expertise. These factors can result in various degrees of variability in the output a laboratory produces.
The second element of the diagnostic process is the professional interpretation. In this step, the pathologist receives all the laboratory “outputs,” reviews all the information, and arrives at a diagnosis. The ability to arrive at the correct diagnosis is largely driven by the pathologist’s training, experience and expertise. If the pattern presenting in the slides and other materials is familiar to the pathologist, either through training or having seen it before, then there is a higher likelihood that they will arrive at the correct diagnosis. In order to qualify to render a diagnosis, the physician must be a board-certified pathologist. However, while there are many subspecialist certifications that provide a higher level of training and subspecialized expertise, there is no regulatory requirement for pathologists to complete these subspecialized training programs in order to diagnose such cases.
For example, we specialize in hematopathology (cancers of the blood system: leukemia, lymphoma, etc.), one of the most complex types of cancers to diagnose. While there is a board certification as a subspecialist hematopathologist, many pathologists with an anatomic pathology certification, who don’t have that board certification, still diagnose blood-related cancers.
Medgadget:*Why did you and your team at Precipio think you could improve upon the industry standards?
Danieli:*We observed a growing gap between the need for subspecialized expertise required to reach the correct diagnosis and what the industry was providing. We recognized that one of the only sources of subspecialized expertise was within premier academic institutions; however, the only patients who were benefitting from that expertise,