Pancreatic cancer is one of the deadliest forms of cancer, mainly due to its aggressive nature and late symptoms. Therefore, prompt and accurate diagnosis is the key to treatment. However, tissue sampling is complicated by the pancreas’ deep location in the abdomen, and therefore there is an increasing need for new biopsy instruments that improve the ability to obtain high-quality samples from the organ. Globally, the incidence and mortality rates have continued to increase, and some experts expect pancreatic cancer to surpass colorectal cancer as the second leading cause of cancer death by 2030.
Cancer.net reports The 5-year survival rate for patients in the United States is currently 11 percent. However, the report states that this number would increase to 42 percent if the cancer is detected at an early stage. Early and accurate diagnosis is therefore of great importance in reducing mortality.
Shortcomings in current pancreatic cancer diagnostics
Today's diagnostic methods for pancreatic cancer are mainly ultrasound, MRI, CT and tissue sampling with endoscopic ultrasound (EUS). The latter method is crucial for diagnosing the disease because it has the highest sensitivity for detecting pancreatic cancer. Via EUS, the doctor can take tumor samples for histological diagnosis with fine-needle aspiration (EUS-FNA) or fine-needle biopsy (EUS-FNB).
Recent studies have shown that EUS-FNB is preferable to EUS-FNA because the biopsy samples contain more tissue and thus have a higher sensitivity for detecting malignancy. Despite the importance of this sampling method, it has its shortcomings. Crucially, the samples are often scanty and contaminated with blood, which complicates the analysis and subsequent diagnostics.
Development of an improved sampling instrument
The Swedish medical technology company BiBBInstruments (“BiBB”) has recognized this gap in cancer diagnostics and developed a sampling method, EndoDrill, which is instead based on core needle biopsy (CNB). CNB is already used successfully today in the diagnosis of breast cancer, among other things.
As pioneers in the field of endoscopic CNB, BiBB intends to offer EndoDrill as the world’s first CE-marked (2020) EUS-CNB instrument. The instrument is motor-driven, which simplifies use and significantly increases biopsy size and quality compared to today’s existing manual instruments. EndoDrill takes samples with intact core tissue that provide more data and are significantly larger and less blood-contaminated than tissue sampled with both EUS-FNA and EUS-FNB methods.
Upcoming clinical evaluation in pancreatic cancer
BiBB has come a long way with the EndoDrill system, which includes a product portfolio with three product variants. Two have been initially evaluated clinically with good results: EndoDrill GI for the diagnosis of tumors in the upper gastrointestinal tract and EndoDrill URO for the diagnosis of muscle-invasive bladder cancer (MIBC). The third variant, EndoDrill EBUS, is in late development and is indicated for lung cancer. BiBB sees strong potential for EndoDrill GI also in pancreatic cancer and the company intends to focus on this indication next. In fact, pancreatic cancer is the most common indication for EUS biopsy.
Starting clinical evaluation in pancreatic cancer will therefore lead to further important value-driving milestones for the company. According to BiBB, clinical partners are eagerly awaiting the continuation of the evaluation of EndoDrill. However, before these activities can take off, BiBB's MDR certification application must be approved. Currently, the company's CE marking is in accordance with the previously applicable MDD regulation, which expired in August 2022.
CEO tells more
BiBB CEO Frederick Lindblad told BioStock more about EndoDrill's potential in pancreatic cancer diagnostics.
Fredrik, why is pancreatic cancer the most common indication for EUS biopsy?
– In just 25 years, EUS-guided biopsy (EUS-FNA, EUS-FNB) has become the preferred method for diagnosing pancreatic cancer – and has been shown to have a higher diagnostic sensitivity (the ability to correctly detect the disease) than other methods for detecting early pancreatic tumors. The sampled tissue is required to confirm the diagnosis and to determine the benign or malignant nature of the tumor. Endoscopy as a method is considered effective, safe and minimally invasive and EUS is the most advanced and fastest growing segment. For the pancreatic indication, EUS is used for diagnosis, staging, as well as for a growing number of therapeutic applications.
What do you hope EndoDrill can offer patients with pancreatic cancer?
– Our goal is to offer a superior EUS biopsy instrument with the highest diagnostic accuracy. With EndoDrill's unique electrically driven rotating needle, it is possible for the first time to obtain true endoscopic core biopsies. Today, conventional EUS-FNA needles detect cancer in approximately 85 percent of cases in the pancreas. However, much more information, such as typing and genetic profiling, is needed to confirm diagnosis, guide treatment and improve outcomes.
– This information is provided by a core biopsy. With EndoDrill’s ability to sample core tissue, we want to offer information-rich biopsies. We aim to approach 100 percent sensitivity and a definitive diagnosis at the first EUS examination, with the aim of saving lives and reducing suffering and healthcare costs. In addition, according to our users, EndoDrill is easier to use even for less experienced EUS endoscopists.
Have you had dialogues with current and potential clinical partners regarding the start of clinical evaluation of EndoDrill within the indication, and if so, how are these dialogues progressing?
– We are in ongoing discussions with EUS endoscopists at several Swedish university hospitals. They are very keen to start the first clinical cases in pancreatic cancer as soon as we have received the new CE marking according to the MDR. The plan is to follow up initial patient cases with a multicenter study.
What type of tissue sample does EndoDrill deliver and why is this important?
– Unlike the mess of cells and tissue fragments taken with conventional EUS needles, EndoDrill can sample visible tissue cylinders, i.e. core biopsies. This type of biopsy is easier to process and has the highest diagnostic accuracy of all types of tissue samples. The development from fine needle sampling to core needle sampling has already revolutionized the diagnostic outcome in breast and prostate cancer. Thanks to the EndoDrill system, endoscopists have for the first time a user-friendly instrument that can take the same high-quality samples in the gastrointestinal tract, e.g. pancreas, stomach, colon and lungs. EndoDrill’s core tissue samples thus make it easier for the physician to distinguish malignancies from benign diseases. In addition, EndoDrill provides additional tissue for molecular profiling for the rapidly growing field of precision medicine.
Finally, what is the market potential for EUS biopsy in pancreatic cancer diagnostics?
– Globally, approximately 495 new patients are diagnosed with pancreatic cancer each year (WHO, 000). Current guidelines recommend tissue diagnostics for two groups of patients who account for up to 2020 percent of patients with pancreatic cancer. This means that the number of potential candidates for EUS biopsy exceeds 85 patients per year. The only thing holding back the increased use of EUS is the lack of advanced equipment and experienced EUS endoscopists, as EUS is technically challenging with a long learning curve. Despite these challenges, the number of EUS procedures in the United States has increased from approximately 400 in 000 to approximately 10 in 000 (MarketScan 2000, all EUS indications).
– It is said that the new era of precision medicine will have the greatest influence on the development of the EUS field for both diagnostic and therapeutic purposes. We see EndoDrill's ability to take better biopsies in a simpler way as an important contribution to this new era of cancer treatment. Therefore, we have high expectations for an exciting future for our EndoDrill concept.