ImCare Biotech
ImCare Biotech is a privately held Doylestown, PA biotech developing the Seravue® LC-SPIK ELISA diagnostic and companion drug compounds for early detection and treatment of hepatocellular carcinoma, serving academic researchers today and targeting clinical laboratories upon FDA clearance.
- Company typePrivate
- Founded2011
- HeadquartersDoylestown, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What ImCare Biotech does
ImCare Biotech, Inc. is a privately held clinical-stage biotechnology company founded in 2011 by Dr. Xuanyong Lu, headquartered at the Pennsylvania Biotechnology Center in Doylestown, PA, with a core team of approximately four executives. The company is developing diagnostic and pharmaceutical products targeting liver cancer, anchored by the proprietary LC-SPIK (Liver Cancer-Specific Serine Protease Inhibitor Kazal) biomarker and its lead diagnostic product, the Seravue® ELISA kit. Seravue has received FDA Breakthrough Device Designation (June 2020) for the early detection of Hepatocellular Carcinoma (HCC), with clinical validation across 1,200+ patients showing 80% sensitivity and 90% specificity for all-stage HCC and 72%/90% for early-stage disease, materially outperforming the AFP standard of care. The company is also advancing drug discovery programs (IMB101, IMB102) and supporting technologies including Immune-absorbance Real-Time PCR (IA-PCR) and the Anti-SPINK1 antibody (BA1).
The business operates on a dual-track model. Today, revenue is generated primarily through direct e-commerce sales of Research Use Only (RUO) and cGMP-grade LC-SPIK ELISA kits ($499–$649 per kit) to academic, government, and non-profit research institutions via shop.imcarebiotech.com. Commercial clinical sales are gated on FDA clearance, after which the company plans to distribute Seravue to hospitals, healthcare providers, and clinical laboratories, with potential automatic Medicare coverage under the CMS MCIT pathway. Non-dilutive funding has been substantial: SBIR Phase I (2012), Phase II (2015), and a Phase IIB Bridge Award of up to $4M over three years (October 2021) from the National Cancer Institute, supplemented by SEC-registered equity raises totaling roughly $1.8M between 2020 and 2023.
The company's strategic positioning rests on a granted US patent (US8193328B2) covering SPIK modulators for anti-cancer and anti-viral use, a pending SPIK antibody patent application, registered Seravue® and LC-SPIK trademarks, and a network of academic co-development partnerships with Harvard Medical School, Drexel University, UC Irvine, Ohio State University, and Thomas Jefferson University. Leadership combines commercial expertise from CEO Aaron Yefei Lu (McKinsey, Stanford, London Business School) with scientific depth from President/Co-founder Xuanyong Lu and CSO Karteek Kadimisetty (PhD, UConn), supported by VP of Engineering Bobby Biswal leading software and AI development for diagnostic modeling.
ImCare Biotech firmographics
Firmographics- Name
- ImCare Biotech
- Legal name
- ImCare Biotech, Inc.
- Website
- https://imcarebiotech.com
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- ImCare Biotech is a privately held Doylestown, PA biotech developing the Seravue® LC-SPIK ELISA diagnostic and companion drug compounds for early detection and treatment of hepatocellular carcinoma, serving academic researchers today and targeting clinical laboratories upon FDA clearance.
- Ownership category
- akta.pro rank
ImCare Biotech industry classification
Industry- Product category
- Cancer Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Pharmaceutical Preparation Manufacturing (325412)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)
- akta.pro secondary industries
- Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)
Keywords
Where ImCare Biotech is headquartered
LocationHeadquarters
- HQ city
- Doylestown
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
ImCare Biotech business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Research Use Only (RUO) ELISA Kits: Sale of research use only ELISA kits for LC-SPIK and AFP biomarker detection. Products sold directly through company's e-commerce platform to academic institutions, research organizations, and non-profit entities. Revenue is transaction-based with one-time purchases.
- Diagnostic Products (Post-FDA Clearance): Upon FDA clearance, Seravue diagnostic kit will be sold for clinical diagnostic use in HCC detection. Targeting healthcare providers, hospitals, and clinical laboratories. Future potential revenue from cGMP grade kits for enhanced applications.
- Government Grants (NIH/NCI): Non-dilutive funding through Small Business Innovation Research (SBIR) grants from National Cancer Institute/NIH. Includes Phase II grant and Phase IIB Bridge Award of up to $4M over three years for commercialization and pivotal clinical study support.
- Securities Offerings: Private securities offerings under SEC Rule 506(b) for equity investment. Historical offerings: approximately $1.28M (2021), $368,415 (2022), $153,402 (2023) as per SEC Form D filings.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Human LC-SPIK ELISA Kit - Seravue® (Research Use Only) |
| Unit Pricing | Pay-as-you-go | Human LC-SPIK ELISA Kit - Seravue® (cGMP Grade) |
| Unit Pricing | Pay-as-you-go | Human AFP ELISA Kit (Research Use Only) |
Go-to-market motion3 records
Distribution channels2 records
Marketing channels5 records
ImCare Biotech product offering
Product offeringCore offering
ImCare Biotech develops and sells ELISA-based diagnostic test kits (Seravue) that utilize its proprietary LC-SPIK (Liver Cancer-Specific Serine Protease Inhibitor Kazal) biomarker for detection of Hepatocellular Carcinoma (HCC). The kits are currently sold for research use only (RUO) to academic and research institutions, with a cGMP-grade variant also offered. The company is pursuing FDA clearance for clinical diagnostic use of Seravue.
Product overview
ImCare Biotech is a biotechnology company focused on liver disease diagnostics and drug development. Its core commercial products are the Seravue® LC-SPIK ELISA Kit (available in RUO and cGMP-grade variants), an FDA Breakthrough Device-designated diagnostic blood test for hepatocellular carcinoma (HCC) based on the proprietary LC-SPIK biomarker, alongside the Human AFP ELISA Kit (RUO). The product portfolio is complemented by the Anti-SPINK1 Antibody (BA1) and the IA-PCR technology platform used internally for drug screening. In drug development, ImCare is advancing IMB101 and IMB102 as novel anti-cancer compounds targeting SPIK-mediated immune evasion. All products are for research use only and not yet approved for clinical diagnosis.
Differentiator
Problem solved
Functional benefit
Brands
- Seravue: The primary diagnostic product brand for ImCare Biotech's liver cancer detection test using the LC-SPIK biomarker. Available as ELISA kits for research use.
Products and services
- Seravue Human LC-SPIK ELISA Kit (RUO) ELISA-based diagnostic test kit for quantification of human LC-SPIK levels in serum and plasma samples for the detection of Hepatocellular Carcinoma (HCC), including early-stage HCC. Sold for research use only to academic, government, and research organizations.
- Seravue Human LC-SPIK ELISA Kit (cGMP Grade) cGMP-grade variant of the LC-SPIK ELISA Kit with assay range 0.31-10.0 ng/mL and sensitivity approximately 0.05 ng/mL. Designed for enhanced quality requirements in research and product evaluation settings.
- Human AFP ELISA Kit (RUO) Research-use-only ELISA kit for the precise quantification of human Alpha-fetoprotein (AFP) levels in serum, plasma, and cellular media samples (assay range 0.25-16.0 ng/mL). Supports hepatocellular carcinoma detection research and multi-analyte biomarker panel testing.
- Anti-SPINK1 Antibody (BA1) Monoclonal antibody that recognizes native human pancreatic secreted SPINK1/TATI/PSTI in Western Blot and ELISA applications, supporting academic research on SPIK/LC-SPIK biology.
- IMB101 and IMB102 (Drug Compounds) Anti-cancer drug compounds in development with IC50 of approximately 1µM and CC50 greater than 100µM in vitro. Designed to restore the immune system's ability to kill oncogenic cells by inhibiting SPIK activity.
Quantifiable outcome
- LC-SPIK AUC 0.87 with 80% sensitivity/90% specificity for all HCC vs AFP AUC 0.70 with 52% sensitivity/86% specificity
- +5 more outcomes
Companies that use ImCare Biotech
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles2 records
ImCare Biotech technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
ImCare Biotech partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- Harvard Medical SchoolcoreDevelopment partnership with Harvard Medical School representing high-profile academic collaboration. Contributed prestigious research validation and expertise to support diagnostic technology development.
- Ohio State UniversitycoreDevelopment partnership for liver cancer diagnostic technology development. Ohio State University contributed research infrastructure and academic expertise.
- Thomas Jefferson UniversitycoreDevelopment partnership established for collaborative research on liver disease diagnostics. Thomas Jefferson University contributed academic research capabilities and clinical expertise.
- Drexel University, College of MedicinecoreImCare Biotech signed agreement with Drexel University's College of Medicine to develop Seravue diagnostic technology. This partnership contributed to the foundational development of the LC-SPIK biomarker technology and Seravue ELISA test for early liver cancer detection.
- University of California, Irvine, Medical CentercoreCollaborated with UC Irvine Medical Center alongside Drexel University for Seravue development. Contributed clinical expertise and resources to support diagnostic kit development for liver cancer detection.
- South-Central University for Nationalities (China)minorStrategic cooperation signed in November 2011 for collaborative research activities related to liver disease diagnostics and treatment development.
- Hubei Cancer HospitalminorStrategic cooperation with Hubei Cancer Hospital in China for liver cancer research and diagnostic development collaboration.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
ImCare Biotech competitors and assessment
Company assessmentDirect peers
- Exact Sciences: Developer of Oncoguard Liver, a blood-based multi-analyte HCC surveillance test in advanced clinical development. Directly comparable to ImCare's Seravue as a competing biomarker-based HCC detection assay targeting at-risk surveillance populations.
- EDP Biotech: Small-cap diagnostics company developing blood-based biomarker tests for early cancer detection, including HCC. Comparable to ImCare as a similarly sized, single-asset-focused liver cancer diagnostics developer.
Broad incumbents
- Bio-Techne: Major supplier of ELISA kits, antibodies, and reagents to academic and translational researchers, including cancer biomarker research. Comparable to ImCare's RUO ELISA kit business as a reagent/research-tools incumbent.
- Abcam: Global supplier of research-use-only antibodies, ELISA kits, and assay reagents, including cancer biomarker products. Comparable to ImCare's RUO kit and Anti-SPINK1 antibody (BA1) product lines as a much larger reagent incumbent.
- Roche Diagnostics: Sells Elecsys AFP and other clinical chemistry assays including PIVKA-II/DCP used in HCC detection. Indirectly competes with Seravue as part of a broad clinical diagnostics portfolio across hospital and reference laboratory channels.
- Abbott Diagnostics: Manufacturer of ARCHITECT AFP and other immunoassays routinely used in HCC workups. Comparable as a large incumbent with established clinical laboratory distribution that any new HCC biomarker would need to displace or complement.
- Fujirebio Diagnostics: Specializes in clinical immunoassays including liver cancer biomarker tests (e.g., AFP-L3, DCP). Comparable as an established specialty diagnostics company with regulatory-cleared HCC biomarker products globally.
Emerging players
- Natera: Developer of Signatera tumor-informed molecular residual disease and early cancer detection tests. Comparable as a blood-based cancer diagnostics peer pursuing novel biomarker approaches, though at significantly larger scale.
- VolitionRx: Clinical-stage diagnostics company developing blood-based nucleosome biomarker tests for cancer detection. Comparable as a small-cap, pre-commercialization cancer diagnostics peer pursuing multi-cancer detection through novel blood-based biomarkers.
- Guardant Health: Developer of liquid biopsy tests for cancer detection and monitoring, with potential applicability to HCC. Comparable as a blood-based cancer diagnostics peer though operating at significantly larger scale and broader cancer focus.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
ImCare Biotech social profiles
Digital presenceImCare Biotech compliance and trust
Trust signalCompliance2 records
ImCare Biotech financial estimates
Financial estimateRevenue estimate
Valuation estimate
ImCare Biotech leadership team
Management profileNumber of profiles
Profiles4 records
ImCare Biotech funding detail
Funding detailFunding overview
Funding rounds4 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ImCare Biotech M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ImCare Biotech
What does ImCare Biotech do?
ImCare Biotech develops and sells ELISA-based diagnostic test kits (Seravue) that utilize its proprietary LC-SPIK (Liver Cancer-Specific Serine Protease Inhibitor Kazal) biomarker for detection of Hepatocellular Carcinoma (HCC). The kits are currently sold for research use only (RUO) to academic and research institutions, with a cGMP-grade variant also offered. The company is pursuing FDA clearance for clinical diagnostic use of Seravue.
Is ImCare Biotech a public or private company?
ImCare Biotech is a private company. It is classified as venture growth investor backed and is currently operating.
When was ImCare Biotech founded?
ImCare Biotech was founded in 2011. It employs 1 to 10 people.
Where is ImCare Biotech based?
ImCare Biotech is headquartered in Doylestown, United States, in the North America region.
How does ImCare Biotech make money?
Four revenue lines are on record. Research Use Only (RUO) ELISA Kits are the primary driver. The others are diagnostic Products (Post-FDA Clearance), government Grants (NIH/NCI) and securities Offerings.
Who are ImCare Biotech's main competitors?
Direct peers on record are Exact Sciences and EDP Biotech. Broad incumbents are Bio-Techne, Abcam, Roche Diagnostics, Abbott Diagnostics and Fujirebio Diagnostics. Emerging players are Natera, VolitionRx and Guardant Health.
Does ImCare Biotech have an API?
No public API is recorded for ImCare Biotech.
What industry is ImCare Biotech in?
ImCare Biotech's product category is Cancer Diagnostics. Its primary akta.pro industry code is HLAGAIAI, Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes), with a secondary code of HLAAAMAC, Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays). Its NAICS code is 325413 and its SIC code is 2835.