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Rapid 3D Whole-Slide Digitization of Thick Cytopathology Slides with a Gigapixel Microscope

Award Number: R44CA250877
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2023

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Rapid 3D Whole-Slide Digitization of Thick Cytopathology Slides with a Gigapixel Microscope - Significance: Digital microscopes are becoming an indispensable tool within the pathology lab. Whole-slide microscope scanners are now routinely used to record gigapixel-sized images of surgical pathology specimens for archival, sharing, annotation and automated processing. Unfortunately, whole-slide scanners still cannot efficiently digitize thick specimens, such as fine-needle aspirates (FNAs) and other cytology samples that are commonly used as the first-line modality for diagnosing cancer of the lung, thyroid, pancreas and other sites. Standard microscope lenses can only capture data from a 1 mm2 area per snapshot. Given this limitation, it is currently not technically feasible to fully scan out an entire slide in 3D, which leads to a number of critical bottlenecks within the cytologist's workflow for cancer diagnosis. Proposal: Ramona Optics is developing a new micro-camera array microscope (MCAM) that can overcome these limitations to digitize thick specimens (up to 50 µm deep) at 1 µm3 volumetric resolution across an entire slide. The resulting multi-gigabyte recording can then be examined by cytopathologists via a custom-developed 3D software interface to aid with various diagnostic tasks. In Phase I of this Fast-Track proposal, Ramona will finalize the hardware and software for its new MCAM-3D device. In Phase II, Ramona will collaborate with the Duke University Medical Center and several other cytopathologists to test and measure MCAM-3D performance on several relevant clinical tasks, including remote telecytology-based assessment of FNA sample adequacy, as well as suitability for secondary diagnosis. Apart from improving workflow and patient care in the hospital, Ramona Optics also expects the MCAM- 3D to enable a number of critical high-throughput imaging experiments in the life sciences that are currently not possible due to the limited throughput of current standard microscope designs. SA1 (Phase I): Integrate hardware and software for whole-slide MCAM-3D capture: Ramona will complete development of an MCAM-3D device that digitizes whole slides (12 cm2 area, 50 µm thick) at 0.8 and 2.6 µm/pixel lateral and axial resolution within 1.5 minutes. 3D viewing software will enable real-time interaction with the multi-gigabyte recorded data volume, offering ~50X more measurements than current 2D whole-slide scanners. SA2 (Phase II): Evaluate MCAM-3D for telecytology and improve system specifications: In collaboration with 3 cytopathologists at the Duke University Medical Center, Ramona will test the MCAM-3D for remote rapid on-site evaluation (ROSE) of sample adequacy. ROSE is well-known to improve patient care by reducing repeat procedures. The objective of this aim is to show that the MCAM-3D can make ROSE easier, quicker and potentially more accurate. At the same time, Ramona will incorporate study findings to improve lateral/axial imaging resolution to 0.5 µm/1 µm and scanning speed to 30 sec. SA3 (Phase II): 3D whole-slide digitization and remote viewing for clinical applications: Ramona will improve the MCAM-3D's processing speeds to enable real-time remote viewing of 3D samples within the Duke University Medical Center. It will then work with cytopathologists to carefully assess its performance at telecytology-based diagnoses and archiving specimen material as it works towards a finalized product for sale 6 months after the conclusion of this project.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	RAMONA OPTICS INC	1007 BURCH AVE	DURHAM	NC	27701	DURHAM	USA	Cancer Detection and Diagnosis Research	000	3	4/11/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,000,000 )
2022	2022	RAMONA OPTICS, INC.	1007 BURCH AVE	DURHAM	NC	27701	DURHAM	USA	Cancer Detection and Diagnosis Research	002	3	8/9/2022	NON-COMPETING CONTINUATION	$1,000,000
2022	2021	RAMONA OPTICS, INC.	1007 BURCH AVE	DURHAM	NC	27701	DURHAM	USA	Cancer Detection and Diagnosis Research	001	2	1/19/2022	EXTENSION WITH OR WITHOUT FUNDS	$64,642
2022	2020	RAMONA OPTICS, INC.	1007 BURCH AVE	DURHAM	NC	27701	DURHAM	USA	Cancer Detection and Diagnosis Research	000	1	1/19/2022	NEW	-$64,642
														Subtotal = $1,000,000

Issue Date FY: 2021 ( Subtotal = $1,000,000 )
2021	2021	RAMONA OPTICS, INC.	1007 BURCH AVE	DURHAM	NC	27701	DURHAM	USA	Cancer Detection and Diagnosis Research	000	2	8/31/2021	EXTENSION WITH OR WITHOUT FUNDS	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $400,000 )
2020	2020	RAMONA OPTICS, INC.	1007 BURCH AVE	DURHAM	NC	27701	DURHAM	USA	Cancer Detection and Diagnosis Research	000	1	4/14/2020	NEW	$400,000
														Subtotal = $400,000

Grand Total All Awards = $2,400,000

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Rapid 3D Whole-Slide Digitization of Thick Cytopathology Slides with a Gigapixel Microscope

Award Number: R44CA250877

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2023

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