KSL Diagnostics
KSL Diagnostics is a CAP-accredited, CLIA-certified reference laboratory in Buffalo, NY, providing specialized cytogenetic, molecular, and immunology diagnostic testing to healthcare providers, transplant programs, and physician practices across five US-licensed states.
- Company typePrivate
- Founded2018
- HeadquartersBuffalo, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What KSL Diagnostics does
KSL Diagnostics, Inc. is a privately held, CAP-accredited and CLIA-certified national reference laboratory headquartered in Buffalo, New York, operating as a wholly-owned subsidiary of KSL Biomedical, Inc. The company provides specialized clinical diagnostic testing across four service lines: oncology cytogenetics (FISH panels for AML, MDS, MPN, CLL, multiple myeloma, ALL, lymphoma, and triple-hit lymphoma, plus conventional karyotyping), diagnostic immunology (HNA, Fungitell®, hepatitis serologies, Sjögren's disease antibodies, and the proprietary COVID-19 Immune Index™), transplant immunology (HLA typing, antibody screening, and deceased/living donor evaluation with 4-hour STAT turnaround), and biochemical/molecular genetics (disaccharidases activity panel). The test menu is built on conventional molecular and cytogenetic platforms (FISH, real-time PCR, flow cytometry, Luminex, gel agglutination, ELISA) and the company holds clinical laboratory permits in New York, Pennsylvania, California, Maryland, and Rhode Island, plus ASHI accreditation and ISO 13485/15189 certifications for affiliated KSL Biomedical manufacturing and laboratory facilities.
The company generates revenue on a fee-for-service, per-test basis billed to healthcare providers under CPT codes (e.g., AML Panel 88271x16, 88275x8; HLA Antibody Screen 86832/86833), with prices not publicly disclosed. Its go-to-market is consultative, sales-led enterprise field sales targeting oncologists, hematologists, pathologists, cytogenetic laboratories, and solid-organ transplant programs, with named anchor relationships at Kaleida Health facilities and Erie County Medical Center. A second channel serves consumers directly through 4 permanent Western New York testing sites and a 25+ partner network of independent pharmacies and urgent care centers, used initially for COVID-19 testing and vaccination pop-ups (Walden Galleria, Rainbow Bridge) that delivered over 500,000 pandemic-era tests. KSL is the central laboratory for ImCare Biotech's FDA Breakthrough Device Designation Seravue® LC-SPIK hepatocellular carcinoma assay and is preparing LDT panel launches in 2026-2027, signaling a planned expansion into solid tumor diagnostics.
KSL Diagnostics firmographics
Firmographics- Name
- KSL Diagnostics
- Legal name
- KSL Diagnostics, Inc.
- Website
- https://ksldx.com
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- KSL Diagnostics is a CAP-accredited, CLIA-certified reference laboratory in Buffalo, NY, providing specialized cytogenetic, molecular, and immunology diagnostic testing to healthcare providers, transplant programs, and physician practices across five US-licensed states.
- Ownership category
- akta.pro rank
KSL Diagnostics industry classification
Industry- Product category
- Clinical Reference Laboratory Services
- NAICS
- Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Reference & Esoteric Testing Laboratories (HLAFAMAJ)
- akta.pro secondary industries
- Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Cytology & Histopathology Diagnostics (IHC, ISH, tissue-based assays) (HLAAALAI), Bioanalytical Testing (PK/ADA/NAb) (HLAGADAA)
Keywords
Where KSL Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Buffalo
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
KSL Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Supply Chain
Revenue model
- Clinical Laboratory Testing Services: Reference laboratory providing diagnostic testing services for oncology, cytogenetics, molecular diagnostics, diagnostic immunology, transplant immunology, and genetic testing. Revenue generated through billable laboratory tests ordered by healthcare providers.
- COVID-19 Testing Services: COVID-19 testing including RT-PCR (30-minute and 24-hour turnaround) and rapid antigen tests provided at testing sites and pop-up locations. Revenue generated through test fees, insurance billing, and government assistance programs.
- Specialized Diagnostic Panels: Comprehensive disease-specific testing panels (e.g., AML Panel, CLL Panel, MDS Panel) and individual FISH probes offered as discrete laboratory tests billed per CPT code
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Transaction based/ take rate | Pay-as-you-go | Laboratory diagnostic tests billed per test or panel |
Go-to-market motion2 records
Distribution channels5 records
Marketing channels7 records
KSL Diagnostics product offering
Product offeringCore offering
KSL Diagnostics is a national reference laboratory providing clinical diagnostic testing services in cytogenetics (FISH panels for leukemia, lymphoma, and myeloma), molecular oncology, diagnostic immunology, transplant immunology (HLA typing and donor evaluation), biochemical/molecular genetics, and infectious disease (including its proprietary COVID-19 Immune Index™ antibody test). Tests are ordered by healthcare providers and delivered through a CAP-accredited, CLIA-certified laboratory operating 24/7 for STAT testing, with results delivered via the KSL Outreach® secure portal.
Product overview
KSL Diagnostics is a national reference laboratory offering integrated clinical diagnostic services across four main divisions: Oncology/Cytogenetics (FISH panels for AML, MDS, MPN, CLL, Multiple Myeloma, ALL, Lymphoma, and Triple Hit Lymphoma plus chromosome analysis), Diagnostic Immunology (HNA, Fungitell®, Hepatitis, Sjögren's Disease, and COVID-19 Immune Index™ testing), Transplant Immunology (HLA typing, antibody monitoring, and donor evaluation for solid organ transplantation), and Biochemical/Molecular Genetics (disaccharidases panel). The company operates as a CAP-accredited and CLIA-certified facility providing comprehensive testing menus across oncology, immunology, genetics, and infectious diseases. KSL also serves as the central laboratory for ImCare Biotech's LC-SPIK hepatocellular carcinoma Clinical Trial Assay. Testing services are supported by a secure reporting portal (KSL Outreach®) and the COVID-19 Immune Index™ for immunity assessment.
Differentiator
Problem solved
Functional benefit
Brands
- COVID-19 Immune Index™: First-of-its-kind antibody test that detects immune response to COVID-19 and assesses risk of infection if subsequently exposed. Correlates COVID-19 virus neutralization against antibody levels.
Products and services
- AML Panel Comprehensive FISH panel for Acute Myeloid Leukemia covering 8 genetic markers including t(15;17) PML/RARA, inv(16) CBFB, t(8;21) RUNX1T1/RUNX1, and key deletions and translocations; KSL guarantees 24-hour STAT results for PML/RARA. Ordered by hematologists, oncologists, and pathology groups for AML diagnosis, prognosis, and treatment guidance.
- MDS Panel FISH panel for Myelodysplastic Syndromes covering del(5q)/monosomy 5, del(7q)/monosomy 7, del(20q)/monosomy 20, Trisomy 8, and 11q23.3 KMT2A. Used by hematologists and pathologists for MDS diagnosis and risk stratification.
- MPN Panel FISH panel for Myeloproliferative Neoplasms detecting PDGFRB and FGFR1 rearrangements and the CML-associated t(9;22) BCR/ABL/ASS translocation. Used to support diagnosis and therapeutic targeting in MPN and CML.
- CLL Panel FISH panel for Chronic Lymphocytic Leukemia covering 6q23.3 MYB, 11q23.3 ATM, Trisomy 12, t(11;14) CCND1/IGH, del(13q), and 17p13 TP53. Used by hematologists for CLL prognosis and treatment selection.
- Multiple Myeloma (MM) Panel FISH panel for Multiple Myeloma using CD138+ plasma cell selection, covering CDKN2C/CKS1B, trisomies, RB1, IGH, and TP53 markers; includes an MM Reflex Panel for IgH rearrangement. Used for myeloma risk stratification and disease monitoring.
- ALL Panel FISH panel for Acute Lymphoblastic Leukemia detecting 8q24.21 MYC, t(9;22) BCR/ABL1, 11q23.3 KMT2A, and 14q32.3 IGH rearrangements. Used to support ALL diagnosis, risk stratification, and targeted therapy decisions.
- Lymphoma Panel FISH panel for lymphoma detection covering BCL6, MYC, CCND1/IGH, IGH, and IGH/BCL2 translocations. Used by pathologists and oncologists to classify lymphoma subtype.
- Triple Hit Lymphoma FISH Panel Specialized FISH panel for high-grade B-cell lymphomas detecting concurrent rearrangements of MYC, BCL2, and BCL6 (double/triple-hit lymphomas) using 18q21.3 BCL2, 3q27 BCL6, and 8q24.21 MYC probes. Used for aggressive lymphoma classification and treatment planning.
- Chromosome Analysis (Conventional Karyotype) Conventional cytogenetic karyotype analysis for hematopoietic malignancies using bone marrow or peripheral blood specimens to detect acquired chromosome abnormalities. Used by hematologists and oncologists alongside FISH panels.
- Human Neutrophil Antibodies (HNA) Test Bead-based multiplex immunoassay detecting neutrophil antibodies associated with TRALI, SLE, RA, Myasthenia gravis, Felty's syndrome, and drug-induced neutropenia. Used by transfusion medicine services and immunologists.
- Fungitell® (1,3)-Beta-D-Glucan Test Qualitative ELISA for invasive fungal infections including Candida, Aspergillus, and Pneumocystis, with an optional reflex to titer. Used by infectious disease and immunology clinicians.
- Hepatitis D (Anti-HDV) Antibody Test Qualitative ELISA for Hepatitis D antibody detection for clinical workup of hepatitis D co-infection.
- Hepatitis E IgG ELISA Qualitative ELISA for Hepatitis E IgG antibody detection used to evaluate prior exposure or immunity.
- Tissue Specific Antibodies in Early Sjögren's Disease Diagnosis Immunoassay billed under PLA code 0522U for early detection of Sjögren's Disease-specific tissue antibodies, supporting autoimmune diagnosis and clinical research.
- Disaccharidases Activity Panel Quantitative spectrophotometry assay of disaccharidase enzyme activity in small intestine tissue biopsies for diagnosis of gastrointestinal dysfunction and lactose intolerance.
- Deceased Donor Evaluation HLA typing and evaluation for deceased organ donors using Real-Time PCR, Flow Cytometry, and Gel Agglutination, with STAT results within 4 hours of receipt. Used by solid-organ transplant programs.
- Living Donor Evaluation Preliminary or final HLA typing for living organ donors, including lymphocyte crossmatch with intended recipients. Used by solid-organ and bone marrow transplant programs.
- HLA Antibody Monitoring Luminex-based HLA antibody screening and identification for pre- and post-transplant monitoring, with reflex to single antigen testing. Used to detect sensitization and inform transplant timing.
- Solid Organ Transplant Candidate Evaluation Comprehensive transplant candidate evaluation combining HLA typing and antibody monitoring using multiple methodologies. Used by transplant centers to evaluate candidates pre-transplant.
- HLA Antibody Screen (Class I and Class II) Luminex-based screening for HLA Class I and Class II antibodies implicated in TRALI, transplant rejection, and bone marrow engraftment.
- COVID-19 Immune Index™ First-of-its-kind antibody test that measures IgG titers and correlates results with plaque reduction neutralization test (PRNT) results to assess immune protection. Used by immunocompromised patients, at-risk populations, and clinicians to inform booster timing.
- LC-SPIK (Seravue®) Hepatocellular Carcinoma Test Clinical Trial Assay for Hepatocellular Carcinoma using the Seravue® ELISA platform to detect the Liver Cancer-Secreted Serine Protease Inhibitor Kazal (LC-SPIK) biomarker, delivered in partnership with ImCare Biotech. Used by oncologists and clinical trial investigators for HCC diagnosis.
Quantifiable outcome
- 100% virus neutralization at IgG levels of 20 and above in COVID-19 Immune Index testing
- +2 more outcomes
Companies that use KSL Diagnostics
Customer profileNamed customers5 records
Segments5 records
Ideal customer profiles4 records
KSL Diagnostics technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
KSL Diagnostics partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core, secondary and minor.
- ImCare BiotechcorePartnership for hepatocellular carcinoma (HCC) diagnostics using LC-SPIK biomarker. KSL Diagnostics serves as central laboratory for Seravue® Validation Study (NCT06994130). KSL to launch LDT panels for HCC in 2026-2027. ImCare Biotech discovered and developed the LC-SPIK liver cancer biomarker.
- State University of New York at BuffalocoreDr. Lakshmanan Suresh serves as Clinical Professor at SUNY Buffalo. Multiple research collaborations with investigators throughout the world. KSL team members maintain academic affiliations and collaborative research programs.
- University at Buffalo Jacobs School of Medicine and Biomedical SciencescoreResearch partnership with UB on SARS-CoV-2 antibody studies leading to COVID-19 Immune Index™ development. Collaborated with Dr. Amy Jacobs on plaque reduction neutralization testing (PRNT) correlation studies using UB's Biosafety Level 3 containment facility. Study funded by UB Center for Advanced Technology in Big Data and Health Sciences (UB CAT).
- University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UB CAT)coreUB CAT, a program of Empire State Development's Division of Science, Technology and Innovation (NYSTAR), supports university-industry collaborations. Funded research on COVID-19 antibody correlation studies and supported commercialization of COVID-19 Immune Index™.
- Brighton-Eggert PharmacysecondaryWNY family-owned community pharmacy since 1968 administers COVID-19 vaccinations at KSL's Walden Galleria pop-up testing site. KSL provides testing infrastructure while pharmacy provides vaccination administration services.
- Walden GalleriaminorShopping mall location hosting KSL Diagnostics pop-up COVID-19 testing and vaccination site on second floor next to Macy's, serving holiday shoppers and Canadian travelers.
- Rainbow Bridge Niagara FallsminorMobile COVID-19 testing site at Rainbow Bridge corner (1st and Niagara Streets) serving cross-border travelers requiring PCR tests for Canadian entry.
Scale indicators5 records
Recent moves6 records
Expansion highlights6 records
KSL Diagnostics competitors and assessment
Company assessmentBroad incumbents
- Sonic Healthcare USA: International reference lab operator with a sizable U.S. footprint in clinical and specialty testing. Comparable as a multi-state reference lab competing in esoteric and specialty diagnostics.
- Quest Diagnostics: Largest U.S. clinical laboratory with national logistics, broad specialty menu, and dominant payor contracts. Competes with KSL on routine and many specialty tests, though at much broader scale and as a partial substitute for hospital outreach.
- Laboratory Corporation of America (Labcorp): Major U.S. national reference lab with extensive specialty/esoteric testing and integrated oncology offerings. Head-to-head competitor for hospital outreach and specialty send-out volumes, with greater commercial scale and payor leverage.
- Mayo Clinic Laboratories: Hospital-affiliated esoteric reference laboratory offering a deep specialty menu across immunology, genetics, and oncology with national specimen shipping. Comparable as a broad esoteric reference lab competing for the same specialty send-out volumes.
Direct peers
- Invitae: Genetic/molecular diagnostics company focused on hereditary cancer and broader genetic testing, serving oncologists and clinicians. Comparable to KSL's genetic testing and molecular oncology capabilities and customer overlap.
- Natera: Molecular diagnostics company with specialty oncology and transplant-related testing (e.g., Signatera, Prospera). Comparable in its oncology-focused specialty menu and its positioning with cancer centers and transplant programs.
- ARUP Laboratories: National esoteric reference laboratory offering specialty testing in transplant immunology, HLA typing, immunogenetics, and diagnostic immunology — the closest large-scale analog to KSL's transplant immunology and esoteric assay portfolio.
- Exact Sciences (Genomic Health): Oncology-focused diagnostics company with commercial specialty assays (e.g., Oncotype DX) sold to oncologists and cancer centers. Comparable in oncology diagnostics sales motion and in developing LDT/commercial assays from novel biomarkers.
- NeoGenomics Laboratories: Specialty oncology reference lab with a deep menu in hematologic malignancy FISH, cytogenetics, and molecular oncology. Most directly comparable to KSL's cytogenetics/FISH business and the same oncologist/cancer-center customer base.
- BioReference Laboratories (OPKO Health): Specialty reference lab historically strong in reproductive, oncology, and esoteric molecular testing. Comparable in offering mix (specialty reference lab serving health systems and clinicians) and in being a regional/specialty-focused competitor to the national incumbents.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
KSL Diagnostics social profiles
Digital presenceKSL Diagnostics compliance and trust
Trust signalCompliance10 records
KSL Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
KSL Diagnostics leadership team
Management profileNumber of profiles
Profiles9 records
KSL Diagnostics subsidiaries and ownership
Company hierarchySubsidiaries2 records
KSL Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
KSL Diagnostics M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about KSL Diagnostics
What does KSL Diagnostics do?
KSL Diagnostics is a national reference laboratory providing clinical diagnostic testing services in cytogenetics (FISH panels for leukemia, lymphoma, and myeloma), molecular oncology, diagnostic immunology, transplant immunology (HLA typing and donor evaluation), biochemical/molecular genetics, and infectious disease (including its proprietary COVID-19 Immune Index™ antibody test). Tests are ordered by healthcare providers and delivered through a CAP-accredited, CLIA-certified laboratory operating 24/7 for STAT testing, with results delivered via the KSL Outreach® secure portal.
Is KSL Diagnostics a public or private company?
KSL Diagnostics is a private company. It is classified as corporate owned and is currently operating.
When was KSL Diagnostics founded?
KSL Diagnostics was founded in 2018. It employs 101 to 250 people.
Where is KSL Diagnostics based?
KSL Diagnostics is headquartered in Buffalo, United States, in the North America region.
How does KSL Diagnostics make money?
Three revenue lines are on record. Clinical Laboratory Testing Services are the primary driver. The others are COVID-19 Testing Services and specialized Diagnostic Panels.
Who are KSL Diagnostics's main competitors?
Broad incumbents on record are Sonic Healthcare USA, Quest Diagnostics, Laboratory Corporation of America (Labcorp) and Mayo Clinic Laboratories. Direct peers are Invitae, Natera, ARUP Laboratories, Exact Sciences (Genomic Health), NeoGenomics Laboratories and BioReference Laboratories (OPKO Health).
Does KSL Diagnostics have an API?
No public API is recorded for KSL Diagnostics.
What industry is KSL Diagnostics in?
KSL Diagnostics's product category is Clinical Reference Laboratory Services. Its primary akta.pro industry code is HLAFAMAJ, Reference & Esoteric Testing Laboratories, with a secondary code of HLAAALAN, Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays. Its NAICS code is 621511 and its SIC code is 8071.