Innovations in Microbiology Testing
Detection of infectious disease promptly and accurately is important because the burden of infectious disease is high. In the United States, chronic lower respiratory diseases were the third leading cause of death in 2015, behind only heart disease and cancer. The Center for Disease Control and Prevention (CDC) reports that 155,041 people died in the United States in 2015 due to chronic lower respiratory diseases.
Infectious diseases are all the more troubling because they may harm long after the disease is treated. These secondary effects – cancer, heart disease – increase the stakes and suggest the need for testing.
Clinical microbiology laboratories perform tests to detect, isolate, identify and characterize microorganisms that cause infectious diseases, and also perform antibiotic susceptibility tests. Traditional microbiology, including culture, microscopy, use of stains plus fluorogenic and chromogenic substrates, and other technologies has b used for several decades in microbiology laboratories. Microbiology tests may be performed using traditional microbiology techniques, or by using newer technologies including immunoassays, molecular microbiology (PCR or other nucleic acid amplification methods), or mass spectrometry.
The following represent recent developments in microbiology that are innovative. For each, we’ve detailed the company, the area the development is in (disease being treated or general procedure such as blood culture), the location of the company so that interested readers can pursue them, and the detail on the innovation and the status (FDA or CE cleared, market = marketed for some time, service, RUO or other).
This table represents some recent innovations in infectious disease diagnostics. For more analysis please see our Infectious Disease World Market Analysis report.
| Company | Location | Area | Details | Stats |
| Abbott | Abbott Park, IL | flu a/b, strep A | ID NOW CLIA Waived POC | FDA |
| Abbott Diagnostics | U.S. | various | Iridica molecular-testing platform | CE |
| Abbott Diagnostics | U.S. | HIV | ARCHITECT HIV Ag/Ab Combo assay | FDA |
| Accelerate Diagnostics | U.S. | blood culture | CRE in blood culture | dev |
| Accelerate Diagnostics | U.S. | blood culture | BacAccelerate ID/AST Blood Culture Assay | CE |
| Advanced Biological Lab | Luxembourg | HCV | Anti-E1/E2-based ELISA for HCV management | dev |
| AdvanDx | U.S. | blood culture | Candida QuickFISH | CE |
| AdvanDx | U.S. | blood culture | gram-positive/negative QuickFISH | CE |
| AdvanDx | U.S. | HAIs | mecA XpressFISH, MRSA | FDA |
| Alere | U.S. | HAIs | BinaxNOW PBP2a test | CE, FDA |
| Alifax | Italy | blood culture | Automated blood culture | FDA,CE |
| Aperiomics | U.S. | microbiome | Absolute-Biome, microbiome sequencing | RUO |
| Aseptika Limited | UK | resp inf | bacterial protein in sputum, CF, asthma, COPD | CE |
| Atomo Diagnostics | Australia | panel | AtomoRapid dengue and chikungunya | dev |
| Beckman Coulter | Brea, CA | Sepsis | Early Sepsis Indicator DxH900 Hematology System | CE |
| Biocartis | Switzerland | ebola | Ebola test with Janssen Diagnostics on Idylla | dev |
| Biohit OYJ | Finland | microbiome | Genetic Analysis AS’s Dysbiosis microbiome for IBD | CE |
| BioInnovation Solutions | Switzerland | filoviruses, such as Ebola and Marburg | dev | |
| bioMereiux | France | various | AE-180 /AE-240 mid throughput immunoassay system | FDA |
| bioMereiux | France | pneumonia | 18 bacteria/8virus/7gene panel | |
| bioMérieux | France | mass spec | assays for Knome sequencing platform | dev |
| bioMérieux | France | ID/AST | VITEK MS, ID/AST on Shimadzu mass spec | CE, FDA |
| bioMérieux | France | ID/AST | BacT/ALERT Virtuo, 15 min result | mkt |
| Bioneer Corp | Korea | Ebola | AccuPower EBOV real-time RT-PCR | RUO |
| Bioneer Corp | Korea | Zika | AccuPower ZIKV Multiplex Zika, dengue, CHIKV | CE |
| Bioneer Corp. | Korea | Ebola | AccuPower EBOV real-time RT-PCR | Nigeria |
| Bio-Rad | Hercules, CA | malaria | multiplex MAG PIX | FDA |
| Bruker Biosciences | U.S. | blood culture | MALDI Sepsityper Solution, positive blood culture | CE |
| Bruker Biosciences | U.S. | blood culture | integrate MALDI Biotyper with BD Phoenix | dev |
| Cajetmo Heredin University | Lima, Peru | chagas | qPCR on clot samples low blood leads | dev |
| Canon BioMedical | U.S. | Lyme | with T2 Biosystems, Lyme Disease, PCR | dev |
| Cepheid | U.S. | TB | Xpert MTB/RIF, TB & rifampin-resistance | FDA |
| Cepheid | U.S. | TB | Xpert XDR-TB, extensive drug resistance, PCR | dev |
| Cepheid | U.S. | ebola | Xpert Ebola, PCR | EUA |
| Cepheid | U.S. | MRSA | Xpert MRSA/SA Blood Culture (BC) | FDA |
| Cepheid/Danaher | HIV | Gene Expert HIV-1 Qual | FDA | |
| Ceres Nanosciences | U.S. | lyme | Nanotrap Lyme Antigen (LA) Test | srvc |
| Chembio Diagnostics | U.S. | ebola | DPP Ebola with Integrated BioTherapeutics | dev |
| Chembio Diagnostics | U.S. | zika | zika added to DPP Fever Panel assay | dev |
| Chembio Diagnostics | U.S. | malaria | DPP Malaria | dev |
| ChromaCode | Carlsbad, CA | tick-borne | 12 spiecies tick panel | service |
| Co-Diagnostics HBDC | U.S. | TB | LogixSma-RT TB Kit | mkt |
| Coris BioConcept | Belgium | chagas | T. cruzi satDNA OligoC-TesT, PCR | mkt |
| CTK Biotech | U.S. | CHICKV | OnSite Chikungunya IgM Combo Rapid Test | CE |
| Curetis AG | Germany | response | Acumen’s AcuSept panel, sepsis immune response | dev |
| DiaSorin | Italy | campy | LIAISON Campylobacter stool test | mkt |
| DiaSorin | Italy | GI | Liaison bacterial stool-testing panel | CE |
| Diaxonhit | France | avidity portfolio active vs older infections | mkt | |
| Diaxonhit | France | sepsis | BJI InoPlex test staph antibodies in blood | CE |
| DiscoGnosis Project | EU | panel | LabDisk 12 pathogens- malaria, dengue, CHICKV | dev |
| DNA Genotek/OraSure | Canada | microbiome | OMNIgene•GUT microbiome collection kit, stool self collect | CE, RUO |
| DPZ Diagnostics | Germany | ebola | Diagnostics-in-a-Suitcase | dev |
| DxNA | U.S. | Valley Fever | Valley Fever (coccidioidomycosis) | dev |
| Dynamiker Biotechnology | China | fungi | ELISA invasive fungal disease | CE |
| EKF Diagnostics | UK | sepsis | Stanbio LiquiColor Procalcitonin, automated analyzers | CE |
| EliTech Group | South Logan, UT | HSV 2 | multiplex six channel test | |
| Enigma Diagnostics | UK | TB | MDR-TB on Enigma Mini Laboratory | dev |
| Epistem Holdings | UK | TB | Genedrive TB and resistance | CE |
| Fast-Track Diagnostics | Luxembourg | Ebola | FTD Ebola assay | CE |
| Fio Corporation | Canada | ebola | Corgenix ReEBOV Ebola antigen on Deki Reader | EUA; FDA |
| Fio Corporation | Canada | lassa | Corgenix ReLASV Lassa virus antigen on Deki Reader | CE |
| Fio Corporation | Canada | micro | Deki Reader Malaria & Dengue, LF | CE |
| GBDbio | U.S. | TB | TB REaD POC test, fluorescent beta lactamase enzyme | dev |
| Genalyte Inc. | U.S. | ebola | Ebola antigens and IgM/IgG antibodies | dev |
| Genalyte Inc. | U.S. | ebola | Ebola antigens and IgM/IgG antibodies | dev |
| GenArraytion | U.S. | zika | MultiFlex Mosquito-borne Panel, zika etc | RUO |
| GeneDrive | Manchester, UK | Hepatitis C | Genedrive POC HCV ID Kit | CE |
| GeneDrive | Manchester, UK | |||
| GeneDrive | Manchester, UK | hep C | 100% specificity test | CE |
| Genetic Analysis | Norway | microbiome | Dysbiosis test microbiome imbalance in irritated bowel syndrome | CE |
| Global BioDiagnostics | UK | TB | TB, Reporter Enzyme Fluorescence | dev |
| Globavir Biosciences | U.S. | dengue | PanGlob RT-PCR Dengue | market |
| Gold Standard Diagnostics | U.S. | syphilis | AIX1000 Rapid Plasma Reagin (RPR) Automated | FDA |
| Great Basin Scientific | U.S. | PCR | Staph ID/R Blood Culture Panel | FDA |
| Hain Lifescience | Germany | TB | GenoType MTBDRsl, colonies & sputum | CE |
| ICDPR | Dhaka, Bangledesh | cholera | Cholkit Dipstick Assay | market |
| Inflamatix | Burlingame, CA | Sepsis | multigene sepsis panel | dev |
| Institute for Preventitive Research | Gottigen, Germany | treporema | Pallidum LAMP technology | dev |
| Jena University | Jena Germany | MIC | MIC determinaion in two hours with LOC tech. | dev |
| LabCorp | U.S. | Zika | Altona’s RealStar Zika Virus RT-PCR Kit | srvc |
| Luminex | Austin, TX | flu a/b | Aries | FDA |
| Luminex | Austin, TX | GI | Verigene II GI assay | dev |
| Luminex | U.S. | panel | GenArraytion MultiFlex Mosquito-borne Panel- Zika, CHICKV, Dengue | dev |
| Lumora | UK | malaria | malaria test, LAMP, with FIND and Eiken | mkt |
| Magnolia Medical | San Mateo, CA | blood culture | U South Car. Study shows 4 fold decrease in contaminiation | study |
| Mass. Institute of Technology | U.S. | panel | Matrix Multiplexed Diagnostic – ebola, dengue, yellow fever | dev |
| Mayo Medical Lab | U.S. | microbiome | microbiome diagnostics on Whole Biome’s Complete Biome Test | service |
| MBio Diagnostics | U.S. | malaria | LightDeck Malaria cartridge | dev |
| MBio Diagnostics | U.S. | malaria | LightDeck Malaria cartridge | dev |
| MBio Diagnostics | U.S. | instr | LightDeck, multiplexed immunoassay platform, cartridge | dev |
| Medical Innovation Ventures | Malaysia | dengue | ProDetect Dengue tests | CE |
| MeMed Diagnostics | Israel | response | ImmunoXpert pathogen immune response proteins | CE |
| Meridian Bioscience | Cincinatti, OH | CMV | Althethia CMV Test | FDA |
| Meridian Biosciences | U.S. | TB | illumigene Mycoplasma Direct assay, improved | CE, FDA |
| Meridian Biosciences | U.S. | dengue | TruQuik | CE |
| Meridian Biosciences | U.S. | malaria | illumigene Malaria | CE |
| Milford Molecular Diagnostics | U.S. | ebola | Ebola RT-PCR | srvc |
| MIT | Cambridge, MA | gene editing | SHERLOCK Diagnostic Platform cas13 | dev |
| Nanologix | U.S. | instr | NanoLogix N-Assay, ELISA | dev |
| OmniBiome Therapeutics | U.S. | microbiome | maternal infections that lead to preterm labor | service |
| OraSure Technologies | U.S. | ebola | OraQuick Ebola Rapid Antigen Test | EUA |
| Ortho Clinical Diagnostics | Raritan, N.J. | HIV | HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) | FDA |
| Quansys Biosciences | U.S. | resp | 14‐plex Pneumococcal Array | dev |
| Quidel | San Diego, CA | h. pylori | Quick chaser test | |
| Quidel | San Diego, CA | viral gastroenteritis | Solana GAS assay small footprint | |
| Quidel | U.S. | resp | Sofia RSV Fluorescent Immunoassay | waived |
| Quidel | U.S. | resp | Sofia Strep A+ Fluorescent Immunoassay | waived |
| Qvella Corp | Canada | sample | Field Activated Sample Treatment pathogen concentration & Dx | dev |
| Research & Diagnostic Antibodies | U.S. | sepsis | PliNOSa Assay Kit | CE |
| Response Biomedical | Canada | sepsis | RAMP Procalcitonin | CE |
| Roche | Indianapolis, IN | zika | cobas zika test 6800/8800 pooled assay | FDA |
| Roche | Indianapolis, IN | CT/NG | RT PCR cobas | FDA, CE |
| Roche | Indianapolis, IN | HPV | cobas 6800/8800 | FDA |
| Sandia National Labs | Livermore, CA | choldera, staph, e.coli | combined immunoassay and NAAT | service |
| Siemens Healthineers | Tarrytown, NY | hep/HIV | HIV, CHIV, EHIV and viral hep. Tests for Attelica Solution pre-market approval | FDA |
| Singulex | U.S. | pathogens | single-molecule counting technology | dev |
| Stellenbosch University | South Africa | TB | Risk 4 test for TB | dev |
| Sysmex | Kobe, Japan | various | UF-5000 blue laser flow cytometry | market |
| Thermo Fisher Scientific | U.S. | MERS | Middle East Respiratory Syndrome Coronavirus (MERS-CoV) | EUA |
| Thermo Fisher Scientific | U.S. | flu | CDC’s influenza A (H7/N9) virus | EUA |
| Transasia Bio-Medicals | India | STD | ErbaLisa Syphilis | mkt |
| U. of California, Irvine | U.S. | HCV | HCV-AGS EIA acute HCV in urine | dev |
| uBiome | U.S. | microbiome | SmartGut, fecal sample seq for a microbiome study of the gut | service |
| University Hopsital | Cologne, Germany | HAIs | rapid test for carbapenmases | dev |
| University of Hong Kong | Hong Kong | RSV | saliva test for respiratory disease | dev |
| USC | Los Angeles, CA | malaria | PODS early stage malraia optics technology | dev |
| ViroCyt | U.S. | sample | ViroTag & Virus Counter 3100 | dev |
