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Deep Whole Genome Sequencing of Aqueous Humor cfDNA for Diagnosis of Intraocular Malignancies

Award Number: R42CA314557
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/07/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Deep Whole Genome Sequencing of Aqueous Humor cfDNA for Diagnosis of Intraocular Malignancies - Project Summary Retinoblastoma (RB)—the most common primary intraocular malignancy of childhood--often cannot be biopsied safely. As a result, clinicians must decide between enucleation, surveillance, or systemic therapy without tissue confirmation. Published series indicate that .10% of eyes enucleated for suspected RB prove benign on final pathology, translating to avoidable, lifelong monocular vision and psychosocial harm for children each year. Similar uncertainty affects other biopsy-inaccessible intraocular cancers (e.g., primary vitreoretinal lymphoma, leukemic ocular infiltration). Aqueous humor (AH) tapping is clinic-feasible and contains abundant tumor-derived cfDNA. Olmeda BioSciences will deliver the first CLIA-grade, ultra-low-input, capture-free whole-genome sequencing (WGS) laboratory-developed test (LDT) for AH cfDNA, centrally run at CHLAfs CLIA-certified Center for Personalized Medicine under Olmeda SOPs, design control, and version-locked analytics. The single-tube workflow sequences every molecule at moderate depth (.50~) and reports genome-wide CNAs, SNVs, and indels from .1 ng input.overcoming the molecule-loss and input requirements that limit panel assays.while targeting a 7. 10 day turnaround and eliminating batching delays. Phase I finalizes chemistry, SOP/QC gates, and containerized pipelines using matched AH. tumor pairs; Phase II executes single-center prospective clinical validation at CHLA-CPM, completes CLIA validation/LDT lock, and assembles a payer-aligned evidence package (PLA/ MolDx). Impact: By converting AH tapping into biopsy-equivalent genomic confirmation, this project aims to (i) reduce unnecessary enucleations of benign mimics, (ii) accelerate correct therapy for malignant cases, and (iii) establish a scalable, payer-aligned, centralized CLIA service with portability to other intraocular cancers. The result is a child-centered advance that improves safety, access, and lifelong outcomes in diseases where biopsy is unsafe.


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: 2026 ( Subtotal = $398,880 )
2026	2026	OLMEDA BIOSCIENCES LLC	7438 TRADE ST UNIT C	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	1	9/7/2026	NEW	$398,880
														Subtotal = $398,880

Grand Total All Awards = $398,880

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Deep Whole Genome Sequencing of Aqueous Humor cfDNA for Diagnosis of Intraocular Malignancies

Award Number: R42CA314557

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/07/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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