Posts

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