What Savyon Diagnostics does

Savyon Diagnostics is a privately held Israeli in vitro diagnostics manufacturer founded in 1984 and headquartered in Ashdod. The company develops, manufactures, and markets diagnostic kits and systems for the detection of infectious diseases across four business segments: Clinical Diagnostics (molecular RT-PCR assays, ELISA and microimmunofluorescence immunoassays, lateral flow rapid tests, and OTC self-testing products), Contract Development and Manufacturing (GMP-certified services for biotech companies from startups to large enterprises), Genetic and Molecular Lab Services (NIPT, pharmacogenetics, wellness testing, genome and exome sequencing), and Analytical Services (GMP-certified glycoanalysis, carbohydrate profiling, and amino acid analysis using HPLC and mass spectrometry).

The company's technology portfolio spans the full diagnostic workflow, including lyophilized RT-PCR master mixes with integrated internal controls, automated nucleic acid extraction (Savvygen Extractor NX-48S processing 48 specimens in 20 minutes), proprietary culture devices (Diaslide, DipStreak, ChromoStreak, UNI-SEP), and CE-IVD and FDA-cleared products. Manufacturing infrastructure includes Class 10,000 ISO 7 clean rooms, a dry room with <30% humidity, and a Biosafety Level 3 laboratory. The OTC/consumer portfolio under the Savvycheck brand includes vaginal yeast, pregnancy, ovulation, StrepA, FOB, amniotic fluid, and cardiac biomarker tests sold through retail channels.

Savyon operates a multi-channel B2B and B2C go-to-market model: direct enterprise sales to clinical laboratories, healthcare facilities, and biotech companies globally via dedicated sales representatives and technical support teams, complemented by OTC retail distribution (with select products limited to the Israeli market). Pricing is not publicly disclosed and follows a one-time/pay-as-you-go model for clinical and OTC products, with professional services engagement for contract manufacturing and analytical work. The company maintains an active digital presence through its website, LinkedIn, and Facebook channels.

Name

Savyon Diagnostics

Legal name

Savyon Diagnostics

Website

https://savyondiagnostics.com

Company type

Private

Founded year

1984

Operating status

Operating

Short description

Savyon Diagnostics is an Israeli in vitro diagnostics manufacturer founded in 1984, producing molecular assays, immunoassays, rapid tests, and OTC self-testing kits for clinical laboratories, point-of-care facilities, home users, and biotech contract manufacturing clients.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Testing Laboratories (8734), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)

akta.pro secondary industries

Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

Keywords

• In vitro diagnostics
• Molecular diagnostic assays
• Immunoassay kits
• Contract diagnostic manufacturing
• OTC self-testing kits

Headquarters

HQ city

Ashdod

HQ country

Israel

HQ region

Middle East

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Personnel, Supply Chain, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Diagnostic Products Sales: Sale of clinical diagnostic products including molecular assays, immunoassays, rapid tests, and microbiology products to clinical laboratories and healthcare facilities.
2. Contract Manufacturing & Development Services: Provides contract manufacturing and development services to biotech companies from startups to large enterprises. Includes assay development, prototype design, scale-up, SOPs, and technical files for regulatory purposes.
3. Analytical Services: GMP-certified analytical laboratory services including glycoanalysis, carbohydrate profiling, amino acid analysis, and molecule interactions/kinetics for pharmaceutical and biotech companies.
4. Genetic & Molecular Lab Services: Lab services including NIPT (Non-Invasive Prenatal Testing), wellness testing, pharmacogenetics, genome sequencing, exome sequencing, RT-PCR, and assay development for clinical and research applications.
5. OTC Products: Over-the-counter diagnostic tests for home use including pregnancy tests, ovulation tests, vaginal health tests, and other consumer-facing rapid diagnostic products.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Savyon Diagnostics develops and manufactures in vitro diagnostic kits and systems for the detection of infectious diseases and other medical conditions, spanning molecular assays (RT-PCR), immunoassays (ELISA, lateral flow, microimmunofluorescence), rapid chromatographic tests, and microbiology urine culture devices for clinical laboratories, point-of-care, and home use. The company also operates contract development and manufacturing services for biotech companies and provides GMP-certified analytical laboratory services including glycoanalysis for pharmaceutical clients.

Product overview

Savyon Diagnostics is an established in vitro diagnostics manufacturer founded in 1984, offering a diversified portfolio of diagnostic products organized across four main business segments: Clinical Diagnostics (molecular and immunological solutions), Contract Development & Manufacturing, Genetic & Molecular Lab Services, and Analytical Services. The Clinical Diagnostics segment spans four product categories: (1) OTC/consumer self-testing products including Savvycheck vaginal yeast infection tests, Savvycheck pregnancy and ovulation tests, Savvycheck StrepA tests, Savvycheck FOB test, VS-SENSE pH swab for BV, and Savvycheck amniotic fluid detection panty liners; (2) Rapid immunoassay tests including Coprostrip C. difficile GDH+ToxA+ToxB, Coprostrip H. pylori, Coprostrip Giardia, QuickStripe Strep A/B, QuickStripe Chlamydia Ag, and Savvycheck SenseA Heart cardiac biomarker test; (3) ELISA immunoassay kits including SeroFIA, SeroELISA, SeroCP, SeroMP, SeroPertussis, CoproELISA H. pylori, and Haptoglobin Typing ELISA; and (4) RT-PCR molecular assays including Savvygen H. pylori & Antibiotic Resistance, Savvygen STI panels (CT/NG/TV, MG/MH, UU/UP), Savvygen HSV 1+2/VZV, Savvygen GI Bacterial Panel, and Savvygen GI Parasites Panel, all supported by Savvygen Extractor NX-48S automation and compatible extraction reagent kits. Microbiology products include Diaslide and Chromostreak urine culture devices, URISCREEN bacteriuria screening test, MacConkey agar plates, Chromagenic UTI Agar, and culture media (BHI, PDA). Laboratory reagents include specimen containers, chemical reagents (HCl, NaOH, ethanol), nucleic acid lysis and transport buffers, Uni-Sep lymphocyte isolation system, and Formalin 10%. Contract Development & Manufacturing services assist biotech companies from concept to product, with GMP-certified facilities including Class 10,000/ISO 7 clean rooms, Biosafety Level 3 laboratory, and automated production lines. Analytical Services offer GMP-certified glycoanalysis including N-linked and O-linked glycan analysis, sialic acid profiling, and monosaccharide analysis using HPLC and mass spectrometry.

Differentiator

Problem solved

Functional benefit

Brands

• Savvycheck: Brand for OTC self-testing diagnostic products including pregnancy tests, ovulation tests, vaginal yeast infection tests, FOB tests, and StrepA tests
• Savvygen
• CoproStrip
• QuickStripe
• SeroFIA
• SeroELISA
• SeroPertussis
• SeroMP
• SeroCP
• Diaslide
• ChromoStreak
• URISCREEN
• VS-SENSE
• AL SENSE
• SenseA Heart

Products and services

• Savvycheck Vaginal Yeast Infection Test (OTC) CE-approved self-testing kit for qualitative detection of Candida antigens in vaginal swab samples, providing results within 10 minutes for home diagnosis of vaginal yeast infection. Designed for non-professional home users.
• Savvycheck Vaginal Yeast Infection Test (Professional/POC) Point-of-care rapid lateral flow assay for qualitative detection of Candida spp. antigens in cervical secretions, with results in 10-20 minutes. Detects 5 Candida species with high sensitivity and specificity for clinical use.
• Savvycheck Pregnancy Test OTC home pregnancy test with 99% accuracy detecting hCG in urine samples at 10 mIU/mL sensitivity, allowing pregnancy detection from the first day of missed period.
• Savvycheck Ovulation Test OTC home ovulation predictor test with 99% accuracy for detection of LH surge in urine to identify the 24-36 hour window for optimal conception timing.
• Savvycheck Panty Liners for Identification of Amniotic Fluid Leakage CE OTC-cleared in vitro self-test for detection of amniotic fluid leakage in pregnant women, distinguishing between amniotic fluid and urine with color-change result reading.
• Savvycheck SenseA Heart Ultra-sensitive point-of-care immunoassay for rapid diagnosis of myocardial infarction using dual cardiac biomarkers (troponin I and heart-type fatty acid-binding protein), detecting heart damage in 30 minutes from onset without requiring instrumentation.
• Savvycheck FOB Test Chromatographic immunoassay for qualitative detection of human fecal occult blood at 50ng/ml or higher, used as a screening test for early signs of colorectal cancer. Sold only in Israel.
• Savvycheck StrepA Stick OTC One-step lateral flow immunoassay for qualitative detection of Streptococcus Group A carbohydrate antigen directly from throat swabs for home use.
• Savvycheck No Step StrepA Test Qualitative lateral flow immunoassay for detection of Streptococcus Group A carbohydrate antigen from throat swabs with no reagent handling required.
• VS-SENSE pH Swab for Detection of BV 10-second vaginal pH test for detection of Bacterial Vaginosis (BV) or Trichomonas Vaginalis (TV), providing easy-to-interpret results based on pH changes.
• Coprostrip C. difficile GDH+ToxA+ToxB Rapid chromatographic immunoassay combo card for simultaneous qualitative detection of Clostridium difficile GDH antigen, Toxin A, and Toxin B in human feces for C. difficile infection diagnosis.
• Coprostrip H. pylori Rapid chromatographic immunoassay for qualitative detection of H. pylori antigens in human feces specimens to aid in diagnosis of H. pylori infection.
• Coprostrip Giardia Rapid chromatographic immunoassay for qualitative detection of Giardia lamblia antigens in human feces specimens with >99% agreement with microscopic examination.
• CoproELISA H. pylori ELISA-based test for screening and detection of H. pylori in human stool specimens, compatible with various preservatives including formalin and SAF.
• QuickStripe Strep B Rapid visual immunoassay for qualitative detection of Group B Streptococcus (GBS) antigens in vaginal or rectal swabs from pregnant women and newborn swabs.
• QuickStripe Strep A Rapid chromatographic immunoassay for qualitative detection of Strep A antigen from throat swab specimens to aid in diagnosis of Group A Streptococcal infection.
• QuickStripe Chlamydia Ag Rapid chromatographic immunoassay for qualitative detection of Chlamydia trachomatis antigens in female cervical swabs, male urethral swabs, and male urine specimens.
• SeroFIA Chlamydia (IgG, IgM, IgA) Microimmunofluorescence (MIF) assays for determination of IgG, IgM, and IgA antibodies to Chlamydia pneumoniae, Chlamydia trachomatis, and Chlamydia psittaci in human serum.
• SeroELISA Chlamydia (IgG, IgM, IgA) ELISA-based determination of IgG, IgA, and IgM antibodies to Chlamydia using L2 serovar broadly reacting antigen, detecting C. trachomatis, C. psittaci, and C. pneumoniae antibodies.
• SeroCP IgG, IgM, IgA (Chlamydia pneumoniae) ELISA-based assays for qualitative detection of antibodies to Chlamydia pneumoniae (TWAR-183) in human serum using purified elementary bodies as antigens.
• SeroMP IgG, IgM, IgA (Mycoplasma pneumoniae) Semi-quantitative ELISA for determination of antibodies to Mycoplasma pneumoniae using enriched P1 membrane protein antigen for complete infection diagnosis.
• SeroPertussis IgG, IgA/IgM ELISA-based serology for Bordetella pertussis using pertussis toxin and filamentous hemagglutinin (FHA) antigens, detecting IgG, IgA, and IgM antibodies.
• Haptoglobin Typing ELISA ELISA kit for qualitative determination of Haptoglobin phenotypes (Hp 1-1, Hp 2-1, or Hp 2-2) in human serum/plasma for diabetic patients, used for cardiovascular disease risk prognosis and Vitamin E treatment assessment.
• Savvygen H. pylori & Antibiotic Resistance First-line screening RT-PCR assay for simultaneous qualitative detection of H. pylori bacteria and clarithromycin resistance mutations from stool specimens, enabling optimal antibiotic treatment selection.
• Savvygen STI CT/NG/TV CE-marked multiplex RT-PCR assay for qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) from urine or vaginal swab specimens.
• Savvygen STI MG/MH RT-PCR assay for qualitative detection of Mycoplasma genitalium (MG) and Mycoplasma hominis (MH) from urine or vaginal swab specimens.
• Savvygen STI UU/UP RT-PCR assay for qualitative detection of Ureaplasma urealyticum (UU) and Ureaplasma parvum (UP) from urine or vaginal swab specimens.
• Savvygen HSV 1+2 / VZV RT-PCR assay for qualitative detection and differentiation of herpes simplex virus types 1 and 2 (HSV-1, HSV-2) and varicella-zoster virus (VZV) in clinical samples.
• Savvygen GI Bacterial Panel RT-PCR assay for qualitative detection and differentiation of Salmonella, Campylobacter, and Shigella/enteroinvasive E. coli (EIEC) in human stool specimens.
• Savvygen GI Parasites Panel RT-PCR assay for qualitative detection and differentiation of Cryptosporidium, Giardia lamblia, and Entamoeba histolytica in human stool specimens.
• Savvygen Extractor NX-48S Automated nucleic acid extraction instrument with walk-away operation, processing 48 specimens in 20 minutes using pre-filled cartridge-type reagents. Features UV lamp, auto door lock, and 7-inch touchscreen interface.
• Diaslide UriSelect/MacConkey Urine Culture Device Semi-quantitative urine culture device with chromogenic UTI selective agar and MacConkey agar for detection, enumeration, and identification of urinary tract pathogens including E. coli, Proteus, and Enterococci.
• Chrostreak UriSelect/MacConkey Urine Culture Device Convenient semi-quantitative screening culture device with unique streaking mechanism for isolation of single colonies from urine samples at bacterial populations up to 10^8 organisms/mL (Cat#BD-915).
• URISCREEN Rapid screening test for bacteriuria and somatic cells in urine with results in 10 seconds, CE and FDA (OTC/POC) cleared, with sensitivity of 5×10^4 CFU/mL.
• Uni-Sep System for Lymphocytes Isolation Ready-to-use patented system for isolation of peripheral blood mononuclear cells and lymphocytes using unique plastic insert for direct blood pouring without special layering precautions.
• Contract Development and Manufacturing Services Contract development and manufacturing services for biotech companies ranging from startups to large enterprises, including assay development, prototype design, scale-up, SOPs compilation, and technical files for regulatory purposes. GMP-certified facilities with Class 10,000/ISO 7 clean rooms, BSL-3 laboratory, and automated production lines.
• Analytical Services (Glycoanalysis & Protein Chemistry) GMP-certified analytical laboratory services for pharmaceutical companies, biotech startups, research institutes, and food/agriculture industry. Includes N-linked and O-linked glycan analysis, sialic acid profiling (NeuAc and NeuGc), quantitative monosaccharide analysis, amino acid analysis, and molecule interactions/kinetics using HPLC and mass spectrometry.
• Genetic & Molecular Lab Services Lab services including Non-Invasive Prenatal Testing (NIPT), wellness testing, pharmacogenetics, whole genome sequencing, exome sequencing, RT-PCR, and assay development for clinical and research applications.

Quantifiable outcome

• Results obtained in 10 minutes for rapid tests
• +4 more outcomes

Named customers7 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Meridian Bioscience (now Revvity Life Sciences): Mid-sized IVD manufacturer with molecular diagnostics, immunoassays, and rapid test portfolios; historically also offered contract development and manufacturing services — directly analogous to Savyon's diversified IVD and CDMO model.
• Sekisui Diagnostics: IVD manufacturer with comparable portfolio across clinical chemistry, immunoassays, molecular diagnostics, and rapid tests, plus OEM/contract manufacturing capabilities — closely overlaps with Savyon's product and services mix.
• Trinity Biotech: Public IVD company with infectious disease diagnostics (HbA1c, Lyme, toxoplasmosis), point-of-care, and clinical chemistry products — comparable in product breadth and mid-tier scale to Savyon's portfolio.
• EKF Diagnostics: UK-listed IVD manufacturer with point-of-care, molecular, and rapid test products, plus contract manufacturing services for diagnostic test developers — closely mirrors Savyon's hybrid product/CDMO business model.

Broad incumbents

• bioMérieux: Global leader in microbiology and infectious disease diagnostics; directly competes with Savyon's microbiology products (Diaslide, ChromoStreak, URISCREEN, culture media) and offers broader IVD solutions worldwide.
• Hologic: Major molecular diagnostics player with a dominant women's health and STI testing franchise (Aptima) — directly overlaps with Savyon's Savvygen STI panels (CT/NG/TV, MG/MH, UU/UP) and multiplex strategy.
• Cepheid (Danaher): Leader in molecular diagnostics with the GeneXpert system for infectious disease testing across CT/NG, GI, and respiratory panels — competes head-to-head with Savyon's Savvygen multiplex RT-PCR portfolio on menu and workflow.
• QuidelOrtho: Combined Quidel and Ortho Clinical Diagnostics; Quidel's Sofia rapid immunoassays and Strep A products directly overlap with Savyon's QuickStripe and CoproStrip rapid test lines.
• SPD Swiss Precision Diagnostics: Consumer diagnostics company behind Clearblue (pregnancy, ovulation); competes directly with Savyon's Savvycheck pregnancy and ovulation tests in the OTC self-testing category globally.

Emerging players

• Trivitron Healthcare: India-headquartered IVD manufacturer with a broad portfolio across immunoassay, molecular diagnostics, rapid tests, and clinical chemistry — emerging global competitor with comparable product breadth to Savyon.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/pages/Savyon-Diagnostics-%D7%90%D7%A9%D7%93%D7%95%D7%93/285429041493072?fref=ts
• LinkedInlinkedin.com/company/129706

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Savyon Diagnostics