The situation
To collect biopsies of the lung, two main methods are currently used:
Transthoracic needle biopsy (TTNA) requires a needle to be inserted through the chest wall from outside the body. The risk of a collapsed lung (pneumothorax) can result up to 61% of the time with an average of 20%. 19
– Navigational Bronchoscopy has emerged as a technology to collect lung biopsies with a low risk of complications, including approximately a 1.5% pneumothorax rate.
Transthoracic needle Biopsy
Lung biopsies are excised from patients and then sent to the laboratory for advanced cancer testing. These tests require that all patients have an adequate amount of high-quality tissue (e.g. with live cancer cells) to be able to conduct the advanced tests such as EGFR, kRas, or PD-1/PDL-1.
Intra-procedurally, he only way to truly assess tissue adequacy is to interrogate /image the biopsy in it’s entirety, to determine 1) do I have the tissue? 2) what exactly am I looking at (cancer cells, immune cells, granuloma)? and 3) do I have enough cells to submit to pathology to gain the best chance of a conclusive diagnosis?
Navigational Bronchoscopy
The problem:
- Inadequate real-time tissue assessment of biopsies
Proceduralists (Bronchoscopist, Radiologists, etc) are currently forced to choose between intraprocedural partial tissue adequacy assessment (ROSE: Rapid On Site Evaluation) or sending tissue samples for full pathology review.
Intra-procedurally, neither truly answering the question, “Do I have enough cells to submit to pathology for the best chance of a conclusive diagnosis?”
This can lead to:
Prolonged delay for patient results
- Waiting days and/or weeks is unacceptable
- Patient emotional stress/anxiety due to the ‘unknown’
- Is it benign? Is my risk small? Do I have cancer? Am I going to die?
Need for a redo procedure
- Current methods result in inconclusive rates as much as 43%
- Inconvenience of a redo procedure for the patient
- Increased risk for a patient complication
- Additional procedure costs associated with a redo procedure
Potential delays in treatment options for the patient
- For a lung cancer patient, the gap in time between diagnosis to treatment/surgery can be life critical!
The solution :
The CelTivity™ Biopsy System
For The Proceduralist
- Know ‘what’s in the cup?’ within 2 minutes!
- Intra-procedurally, image the entire tissue sample vs a partial sample
- No staining or sacrificing the sample
- Does not require onsite cytopathology
For The Hospital
- Potentially reduce the number of lung biopsy redo procedures
- Potentially improve patient satisfaction scores
- Deliver substantial payer savings
For The Patient
- Potentially reduce current delays with obtaining patient results
- Potentially reduce the time gap between patient diagnosis to cancer treatment/ surgery
The CelTivity™ Difference
Dynamic Cell Imaging™
Confocal Laser endomicroscopy (CLe)
Optical Coherence Tomography (OCT)
Do I have the right tissue?
Can I identify what I’m looking at?
Did I get enough cells for the best chance of a conclusive diagnosis?
Dynamic Cell Imaging™
Do I have the right tissue?
Yes
Can I identify what I’m looking at?
Yes
Did I get enough cells for the best chance of a conclusive diagnosis?
Yes
Confocal Laser endomicroscopy (CLe)
Do I have the right tissue?
Yes
Can I identify what I’m looking at?
Maybe?
Did I get enough cells for the best chance of a conclusive diagnosis?
No
Optical Coherence Tomography (OCT)
Do I have the right tissue?
Yes
Can I identify what I’m looking at?
No
Did I get enough cells for the best chance of a conclusive diagnosis?
No
