Cytopath Biopsy Lab Inc.

Cytopath Biopsy Lab Inc., operating as Cblpath and headquartered in Rye Brook, New York, is a for-profit provider of proprietary ThyroSeq molecular diagnostic laboratory testing for thyroid cancer risk assessment, functioning as a prime contractor (100% of recent awards) across the Department of Veterans Affairs healthcare system and the Defense Health Agency on full-and-open competitive awards with no socioeconomic set-aside designations.

The vendor operates exclusively as a prime contractor delivering specialized in-house molecular diagnostic testing without subcontractor engagement. Cblpath's federal capability footprint is monolithic: ThyroSeq V3 genomic sequencing and classifier testing, a proprietary assay that analyzes genetic mutations in thyroid nodules to assess malignancy risk and inform clinical decision-making for veteran and active-duty populations. Recent representative work includes a $2.36 million Blanket Purchase Agreement with Veterans Integrated Service Network 1 (awarded September 2026, running through September 2031) for ThyroSeq v3 genomic classifier testing at VA Connecticut; a $1.01 million BPA with VISN 19 (September 2026 through September 2031) for molecular thyroid testing at the Rocky Mountain Regional VA Medical Center; a $2.25 million BPA with VISN 6 (October 2025 through September 2030) for ThyroSeq genomic testing across multiple North Carolina and Virginia facilities; and a $788.7 million firm fixed-price purchase order with VISN 21 (awarded August 2024, running through August 2029) for ThyroSeq V3 Classifier CPT testing—the largest single award in Cblpath's portfolio.

Customer concentration sits heavily within the Veterans Health Administration regional networks. The top five customers account for 73% of combined potential value: the Defense Health Agency leads by dollar magnitude ($9.8 million across 12 awards), followed by VISN 1 ($7.8 million, 13 awards), VISN 6 ($4.2 million, 20 awards), VISN 22 ($4.1 million, 5 awards), and VISN 19 ($3.2 million, 14 awards). When ranked by award count, VISN 6 leads (20 awards) but carries lower per-award magnitude than the Defense Health Agency's award set, signaling that Defense Health Agency contracts trend larger. Cblpath serves 16 distinct federal customer agencies in total, though VA VISNs and Defense Health Agency dominate; other customers include the National Institutes of Health's National Institute of Diabetes and Digestive and Kidney Diseases.

Cblpath holds nine single-award indefinite delivery vehicles (BPAs and IDIQs) across multiple VA regional networks. The top five vehicles by combined potential value include the VISN 1 BPA ($2.36 million, 7 task orders), the VISN 6 BPA ($2.25 million, open for multiple calls), the VISN 2 IDC ($1.8 million ceiling, 4 delivery orders issued to date), the VISN 21 IDC ($500 thousand, 4 delivery orders issued), and the VISN 19 BPA ($1.01 million, three annual BPA calls). All contracts use firm fixed-price pricing and compete on full-and-open basis without set-asides. Cblpath's sole-source procurement posture is notable: several awards explicitly cite ThyroSeq as proprietary technology exclusive to Cytopath Biopsy Lab Inc., enabling sole-source awards under FAR 13.106-1(b)(1)(i) exclusive licensing provisions and pre-solicitation notices emphasizing the contractor as the exclusive manufacturer.

Award activity has grown from 14 awards in 2022 to a peak of 19 in 2024, with 13 awards recorded in 2026 year-to-date. Fourteen awards carrying combined potential value of $1.7 million reach ultimate completion inside the next twenty-four months, creating recompete exposure for the vendor and recompete opportunity for competitors. SCI-reported invoiced revenue on federal service contracts above the $150,000 threshold totaled $1.9 million across FY2022–FY2025, with $898 thousand invoiced in FY2025 across roughly 0.6 FTEs; the SCI dataset reflects only contracts above $150,000 and excludes goods, products, and non-federal revenue, so this figure substantially understates Cblpath's total federal services footprint. On SCI-reportable service contracts, government-paid rates ranged from approximately $667/hr at the 10th percentile to $54,667/hr at the 90th percentile, with a median around $5,667/hr, reflecting the diagnostic-laboratory service model. The vendor performs zero subcontractor hours on its prime contracts, operating an integrated in-house delivery model.