Search Results

The GenASIs ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern; and shape. The GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types:

1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, Paraffin embedded human breast cancer tissue specimens with Vysis® Path Vysion™ HER-2 DNA Probe kit. Results from the PathVysion™ Kit are intended for use as an adjunct to existing clinical and Pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The Path Vysion™ kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5fluorouracil (CAF) chemotherapy.
3. Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
4. Gene rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit.

The GenASIs ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The GenASIs ScanView System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The system is designed to work with a manual or automated microscope and includes a dedicated, high powered microscope camera combined with state-of-the-art image analysis software for clinical and research oriented image analysis.

The system's modular platform enables automation of a wide range of laboratory selected assays in pathology and cytogenetics applications. This flexible solution may be adapted to the advanced automation and workflow needs of any laboratory or research institution. The system includes a fully automated computer-controlled microscope, motorized 9-slide stage and high powered microscope-camera. This platform also comes with a variety of additional components such as oil dispenser, automated fluorescent illumination control and state-of-the-art image analysis software for clinical and research oriented image analysis and automatic robotic slide loading system, enabling high throughput automated slide analysis for a wide range of pathology applications that provides a true "walk-away" functionality, scanning up to 81 slides consecutively without human intervention. These scanning capabilities presented with the GenASIs High Throughput platform offer an efficient way to optimally use the scanning and analysis system for uninterrupted scanning.

Acceptance Criteria and Device Performance Study for GenASIs ALK System

1. Table of Acceptance Criteria and Reported Device Performance

• For manually counted 61%: Mean 56.9, SD 4.6, %CV 8.0
• For manually counted 52%: Mean 46.9, SD 5.9, %CV 12.6
• For manually counted 85%: Mean 79.6, SD 5.2, %CV 6.5
• For manually counted 18%: Mean 22.2, SD 2.9, %CV 13.2
• For manually counted 27%: Mean 26.7, SD 4.2, %CV 15.9
• For manually counted 31%: Mean 29.6, SD 5.7, %CV 19.2
  Between-Day:
• For manually counted 61%: Mean 56.4, SD 3.7, %CV 6.7
• For manually counted 52%: Mean 47.5, SD 4.3, %CV 9.1
• For manually counted 85%: Mean 80.0, SD 3.8, %CV 4.8
• For manually counted 18%: Mean 25.2, SD 4.8, %CV 19.1
• For manually counted 27%: Mean 27.8, SD 3.8, %CV 13.6
• For manually counted 31%: Mean 32.6, SD 6.4, %CV 19.6
  Between-System:
• For manually counted 61%: Mean 56.2, SD 3.1, %CV 5.5
• For manually counted 52%: Mean 46.1, SD 4.4, %CV 9.5
• For manually counted 85%: Mean 79.4, SD 3.5, %CV 4.5
• For manually counted 18%: Mean 24.4, SD 5.0, %CV 20.5
• For manually counted 27%: Mean 28.3, SD 4.1, %CV 14.4
• For manually counted 31%: Mean 32.2, SD 5.9, %CV 18.2
  Within-day/Within Repeatability for specimens around the cutoff (10-25%):
• For manually counted 12%: Mean 11.6, SD 1.62, %CV 13.9
• For manually counted 19%: Mean 18.6, SD 1.13, %CV 6.0
• For manually counted 22%: Mean 19.7, SD 0.6, %CV 3.1
• For manually counted 18%: Mean 17.6, SD 0.98, %CV 5.6
• For manually counted 19%: Mean 19.6, SD 1.32, %CV 6.7 |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: A total of 179 slides were used in the method comparison study for the test set. This included 9 cases within the equivocal zone (10-50%).
• Data Provenance: The slides were archived formalin-fixed paraffin-embedded (FFPE) tissue specimens from patients with non-small cell lung cancer (NSCLC) that had been previously counted and analyzed manually within the last 6 months at four different clinical sites. Negative cases were selected sequentially from a known bank of negative samples. All available positive and equivocal slides during the comparison studies were included. Patients included in the study were negative for the EGFR test.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document states that the ground truth for the test set was established by manual counting results that were performed "in the last 6 months" prior to the study. It does not explicitly state the number of experts used for these manual counts for each individual slide in the test set. However, the study involved four clinical sites, implying that multiple individuals performed these manual counts across the sites. The qualifications of these experts are not explicitly detailed beyond being the standard practice for "manual counting" in a clinical laboratory setting.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the ground truth. It states that the GenAsIs ScanView operator had "no prior knowledge of the manual counting results." This implies that the manual counts served as the primary, pre-established reference standard against which the device's performance was compared, rather than a process of reaching consensus after the device results were obtained.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study compares the device's performance against pre-existing manual counts and assesses the device's own precision and reproducibility. There is no information provided about human readers improving with AI vs. without AI assistance. The GenASIs ALK System is described as an "adjunctive automated enumeration tool in conjunction with manual visualization," suggesting it is intended to assist, but the study design does not directly measure the effectiveness of this human-in-the-loop improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The "Analytical Performance" section (Table 1) directly compares the GenASIs ScanView results (algorithm only, as the operator had "no prior knowledge of the manual counting results") against the manual method. This demonstrates the algorithm's performance without direct human intervention in the result determination during the comparative phase. The "Precision/Reproducibility" studies also evaluate the device's standalone consistency.

7. Type of Ground Truth Used

The ground truth used was expert consensus / manual counting results performed by laboratory personnel at the clinical sites. These manual counts were established prior to the device's evaluation and served as the reference standard.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set. It focuses solely on the validation study using the test set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established, as details about a training set are not included in this submission summary.

Ask a specific question about this device