What Credo Biomedical does

Credo Diagnostics Biomedical is a Singapore-headquartered molecular diagnostics company founded in 2011 that develops, manufactures, and commercializes rapid point-of-care PCR testing platforms for human clinical diagnostics and veterinary medicine. The company operates three core instrument platforms: VitaSIRO solo™, a standalone cartridge-based system integrating nucleic acid extraction with multiplex real-time PCR (up to 6 targets, 40-minute turnaround); VitaPCR™, a compact 1.2 kg real-time PCR system delivering results in 20 minutes; and QubeMDx+™, a veterinary-focused platform. Supporting infrastructure includes VitaDataLink™ connectivity software (HL7 integration with LIS, EMR, HIS) and a Contract Development and Manufacturing Organization (CDMO) service line. The company holds ISO 13485 and MDSAP manufacturing certifications and has CE marks under IVDR/IVDD across its major platforms.

The company generates revenue through three streams: sale of diagnostic instruments, sale of proprietary assay cartridges and reagents (consumables), and CDMO services. Approximately 90% of instruments and cartridges are manufactured in-house at a Taiwan facility, which the company cites as the basis for its low-cost positioning — US launch pricing is set at $6,000 per VitaSIRO solo system and $20 per assay cartridge. Sales occur through distribution partnerships in more than 50 countries, targeting hospitals, emergency departments, clinical laboratories, veterinary clinics, and health system administrators. The VitaPCR platform generated significant revenue during the COVID-19 pandemic; respiratory demand has since normalized to seasonal patterns. The company is currently preparing for US market entry with clinical trials at 15 sites to support an FDA 510(k) submission for VitaSIRO solo, has stated plans to pursue a Nasdaq listing in 2027/2028, and is privately held with no disclosed VC or PE investment to date.

Name

Credo Biomedical

Legal name

Credo Diagnostics Biomedical Pte. Ltd.

Website

https://credodxbiomed.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Credo Diagnostics Biomedical, founded in 2011 and headquartered in Singapore, develops and manufactures rapid point-of-care real-time PCR molecular diagnostic platforms (VitaSIRO solo, VitaPCR, QubeMDx+) and consumable assays for hospitals, clinical laboratories, veterinary clinics, and health systems across 50+ countries, with manufacturing in Taiwan and an FDA 510(k) US entry underway.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics / Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Point-of-care molecular diagnostics
• Real-time PCR systems
• Rapid PCR assays
• Veterinary molecular diagnostics
• CDMO diagnostic services

Headquarters

HQ city

Singapore

HQ country

Singapore

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Instruments: Sale of diagnostic instruments including VitaPCR™ and VitaSIRO solo™ systems for point-of-care molecular testing
2. Diagnostic Assays and Reagents: Sale of proprietary assay cartridges and reagents for use with company's diagnostic platforms. Assays include respiratory panels, HPV tests, STI tests, genetic tests, and veterinary diagnostics.
3. CDMO Services: Contract Development and Manufacturing Organization services including assay development, sample processing, enzyme development, and instrument/system development for partners.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Credo Biomedical develops, manufactures, and commercializes rapid point-of-care molecular diagnostic platforms (VitaSIRO solo and VitaPCR) and a broad menu of real-time PCR assays for human infectious disease, women's health, and genetic testing, alongside the QubeMDx+ veterinary platform and VitaDataLink connectivity software. The company sells these systems and consumables primarily through distribution partners in 50+ countries, and complements the products with ISO 13485 / MDSAP certified contract development and manufacturing (CDMO) services.

Product overview

Credo Diagnostics Biomedical is a molecular diagnostics company offering point-of-care testing platforms and assays for human clinical diagnostics and veterinary medicine. The product portfolio centers on two main diagnostic platforms: VitaSIRO solo™ (a next-generation standalone system integrating nucleic acid extraction and real-time PCR with multiplex capacity up to 6 targets) and VitaPCR™ (a compact rapid PCR system delivering results in 20 minutes). Supporting these instruments is VitaDataLink™, a data management solution enabling connectivity with LIS, EMR, and HIS systems. The human diagnostics assay menu includes respiratory panels (SARS-CoV-2/Flu/RSV), women's health tests (HPV, CT/NG/TV/MG), genetic testing (MT-RNR1 SNP, ADH/ALDH SNP), and infectious disease tests (Strep A, Influenza, Flu/RSV). The veterinary division offers the QubeMDx+™ platform with assays for avian sexing, canine and feline respiratory/gastrointestinal/blood infections, vector-borne diseases, and zoonotic pathogens. The company also provides CDMO services for assay development, sample processing, enzyme development, and instrument manufacturing with ISO 13485 and MDSAP certification.

Differentiator

Problem solved

Functional benefit

Products and services

• VitaSIRO solo™ Standalone point-of-care molecular diagnostic platform integrating nucleic acid extraction and real-time PCR in a cartridge-based design, with multiplex capacity of up to 6 targets per sample, 40-minute turnaround, 7-inch touchscreen, and connectivity to LIS/HIS via POCT1-A protocols. Intended for hospitals, clinical laboratories, and point-of-care settings performing respiratory, women's health, and genetic molecular tests.
• VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay Multiplex RT-PCR assay for the VitaSIRO solo instrument that detects and differentiates SARS-CoV-2, influenza A and B, and RSV from nasal and nasopharyngeal swabs in approximately 40 minutes; CE-marked.
• VitaSIRO solo™ HPV Assay Point-of-care test detecting and differentiating high-risk HPV subtypes (HPV16, HPV18/45, and 11 additional high-risk subtypes) from cervical swabs with results in 45 minutes in a sample-in/result-out workflow; CE-marked.
• VitaSIRO solo™ CT/NG/TV/MG Assay Point-of-care nucleic acid amplification test (NAAT) for simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium from urine, vaginal, and cervical swabs, with results in 45 minutes. Research Use Only.
• VitaSIRO solo™ MT-RNR1 SNP Assay Point-of-care test detecting the MT-RNR1 single nucleotide polymorphism (m.1555G variant) associated with aminoglycoside-induced hearing loss, with results in 20 minutes from buccal swab samples using an extraction-free workflow with less than 3 minutes hands-on time.
• VitaSIRO solo™ ADH/ALDH SNP Assay Rapid genetic test for ADH1B and ALDH2 gene variants associated with alcohol metabolism and intolerance, using non-invasive buccal swab sampling and automated processing for results in 20 minutes.
• VitaPCR™ Compact rapid molecular diagnostic instrument based on real-time PCR that delivers sample-to-results in 20 minutes at the point of care, weighing 1.2 kg with a 4-inch touchscreen, CE-marked under IVDR, and requiring no additional equipment or reagent refrigeration.
• VitaPCR™ SARS-CoV-2 Gen 2 Assay Rapid RT-PCR assay for the detection of SARS-CoV-2 targeting the N1 and N2 nucleocapsid genes from nasopharyngeal or oropharyngeal swabs on VitaPCR, with less than 1 minute hands-on time and results in 20 minutes; CE-marked under IVDD.
• VitaPCR™ Influenza/SARS-CoV-2 (Flu/SC2) Assay Rapid diagnostic test simultaneously detecting Influenza A (M gene), Influenza B (NS gene), and SARS-CoV-2 (N gene) from nasopharyngeal swabs on VitaPCR, with a 1-minute hands-on procedure and results in 20 minutes.
• VitaPCR™ Flu/RSV Assay Rapid molecular diagnostic test for detection of Influenza virus and RSV (RSV N gene) from nasal or nasopharyngeal swabs on VitaPCR, delivering results in 20 minutes with 1-minute hands-on time.
• VitaPCR™ Strep A Assay Rapid diagnostic test for detection of Group A Streptococcus (GAS) targeting the spy1258 gene from oropharyngeal or throat swabs on VitaPCR, providing results in 20 minutes to support antimicrobial stewardship.
• QubeMDx+™ Point-of-care molecular diagnostic platform for veterinary use that delivers lab-quality PCR results for multiple pathogens in 20 minutes using real-time PCR technology. Veterinary use only.
• QubeMDx+™ Avian Sexing Examination Kit Molecular sexing kit for birds using non-invasive feather samples, detecting CHD gene length differences between Z and W chromosomes to distinguish males (ZZ) from females (ZW), with results in approximately 1 hour and ambient-temperature reagent storage. Includes lyophilized PCR reagents, loading dye, and positive control, and is compatible with multiple avian primer sets.
• QubeMDx+™ Respiratory Assays Molecular diagnostic assays for canine and feline respiratory pathogens, including Canine Respiratory Viral Assay (CDV, CAV1&2, CPIV), Feline Respiratory Viral Assay (FHV, FCV), and Feline Respiratory Bacterial Assay (M. felis, C. felis, B. bronchiseptica), with results in 20 minutes.
• QubeMDx+™ Gastrointestinal Assays Molecular diagnostic assays for canine and feline gastrointestinal pathogens, including Canine GI Assay (CPV/CCV/Giardia) and Feline GI Assay (FPV/FCoV/Giardia), detecting viral and parasitic infections from stool and rectal swabs with results in 20 minutes.
• QubeMDx+™ Feline Blood Infection/FIV/FELV Assays Molecular diagnostic assay for detection of Feline Immunodeficiency Virus (FIV) and Feline Leukemia Virus (FELV) from whole blood (EDTA), enabling early diagnosis as recommended by AAFP, with results in 20 minutes.
• QubeMDx+™ Vector-borne Disease Assays Molecular diagnostic assays for canine vector-borne diseases including Canine Blood Infection Assay (Babesia/B. burgdorferi), Canine Babesia Assay (B. gibsoni/B. canis/B. vogeli), Canine Blood Infection Assay (CHW/E. canis/A. phagocytophilum & A. platys), Haemoplasma/Bartonella Assay, and Hepatozoon/Rickettsii Assay, run on the QubeMDx+ system.
• QubeMDx+™ Canine Zoonotic 3 in 1 Assay Multiplex molecular diagnostic assay for simultaneous detection of Leptospira spp., Leishmania spp., and Brucella canis from whole blood on the QubeMDx+ platform, supporting rapid clinical decision-making and infection control strategies.
• Molecular Diagnostics Total Solution (CDMO Services) Contract Development and Manufacturing Organization (CDMO) services offering end-to-end molecular diagnostic development including assay development, sample processing, enzyme development, and instrument/system development. Backed by ISO 13485 and MDSAP certified manufacturing operations in Taiwan, and intended for partners and customers seeking outsourced molecular diagnostics manufacturing capability.

Quantifiable outcome

• VitaPCR achieved 98.2% positive percent agreement and 100% negative percent agreement with Cepheid Xpert Xpress CoV-2/Flu/RSV plus assay
• +2 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature4 records

Partnerships

One partnership is on record.

• MedTech Innovator ProgramminorGTM or Marketing Partner · 20 September 2024Credo is a member of the MedTech Innovator Program, which helps them learn about US reimbursement and supports their market entry strategy for the US diagnostic testing market.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Cepheid (Danaher): Cepheid's GeneXpert Xpress system is the gold-standard rapid molecular diagnostic platform that Credo explicitly benchmarks its VitaSIRO solo against (predicate device). Both target point-of-care PCR testing for respiratory pathogens in hospital and clinical settings with similar sample-to-result workflows.
• Abbott: Abbott's ID NOW (formerly Alere i) is a leading point-of-care molecular diagnostics platform delivering rapid PCR and isothermal results. Competes with Credo's VitaPCR in decentralized clinical settings like urgent care, emergency rooms, and physician offices for rapid infectious disease testing.
• Roche: Roche's cobas Liat system is a compact point-of-care PCR platform with a menu including Strep A, influenza, RSV, and SARS-CoV-2 assays - directly competing with VitaPCR's test menu in hospitals and clinics globally.
• bioMérieux (BioFire): BioFire FilmArray is a syndromic point-of-care molecular diagnostic platform offering multiplex panels (respiratory, GI, bloodstream, meningitis). Competes with Credo's VitaSIRO solo multiplex cartridge architecture in hospital and clinical laboratory settings.
• Qiagen: Qiagen's QIAstat-Dx is a cartridge-based real-time PCR multiplex system targeting syndromic respiratory, GI, and meningitis/encephalitis testing. Closely comparable to VitaSIRO solo's all-in-one cartridge format and multiplex detection strategy.
• QuidelOrtho: QuidelOrtho's Savanna platform (acquired from DiaSorin/Mobidiag) is a cartridge-based rapid PCR multiplex system for point-of-care testing. Competes directly with Credo's VitaSIRO solo in decentralized clinical settings with similar turnaround time targets.
• Cue Health: Cue Health developed a compact molecular diagnostic platform for at-home and point-of-care COVID-19, influenza, and respiratory testing. Competes with VitaPCR in the rapid decentralized PCR space targeting similar customer segments of consumers, clinicians, and employers.

Emerging players

• Visby Medical: Visby Medical has developed a single-use PCR diagnostic device for sexually transmitted infections (CT/NG/TV) - directly competing with Credo's planned VitaSIRO solo CT/NG/TV/MG STI panel and pursuing similar point-of-care molecular STI testing economics.

Broad incumbents

• IDEXX Laboratories: IDEXX is the dominant veterinary diagnostics company with broad in-clinic and reference lab testing for companion animals. Competes with Credo's QubeMDx+ veterinary platform in the molecular veterinary diagnostics market with established vet clinic relationships.
• Zoetis: Zoetis is the largest animal health company with diagnostics offerings including point-of-care veterinary instruments. Overlaps with Credo's QubeMDx+ portfolio in companion animal molecular diagnostics, particularly feline and canine infectious disease testing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@credodiagnosticsbiomedical1861
• LinkedInlinkedin.com/company/credo-diagnostics

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

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 Credo Biomedical