Treponema pallidum

Microbix & BioGX Collaborate on real-time PCR Assays & Controls

Retrieved on: 
Thursday, December 7, 2023
Herpes simplex, Chickenpox, Mpox, OTCQX, Collection, Business, Applied Biosystems, PCR, Syphilis, Refrigeration, COVID, Business development, SARS-CoV-2, TSX, SVP, Pleasure, XFree86, Treponema pallidum

Microbix was chosen by BioGX to be the primary External Quality Controls provider for assays on their newly-launched pixl platform – a benchtop instrument with capabilities for syndromic testing.

Key Points: 
  • Microbix was chosen by BioGX to be the primary External Quality Controls provider for assays on their newly-launched pixl platform – a benchtop instrument with capabilities for syndromic testing.
  • Microbix QAPs are now referenced in BioGX Assay Product Inserts (available at https://www.biogx.com ), with additional QAPs to be referenced as the collaboration expands.
  • Xfree technology provides a complete lyophilized test in a single tube – using the trusted BioGX Sample-Ready™ format for extraction-free, direct sample addition in real-time PCR testing.
  • Phil Casselli, SVP of Sales & Business Development at Microbix, commented, “It has been a pleasure to work with Robert and his team at BioGX to support their customer base with robust External Quality Controls.

Microbix & Labquality Create Novel Testing Accreditation Program

Retrieved on: 
Tuesday, June 20, 2023
GUD, HSV, Treponema, Accreditation, Mouth ulcer, EQA, Infection, Mpox, QAP (Colombia), Treponema pallidum, Project management, Varicella zoster virus, OTCQX, TSX, Diagnosis, Disease, Pharmaceutical industry

MISSISSAUGA, Canada and HELSINKI, Finland, June 20, 2023 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter and Labquality Oy (Labquality), a global provider of laboratory external quality assessment (“EQA”) programs, announce their creation of the world’s first program to support accreditation of clinical laboratories for detecting the pathogens most commonly causing genital ulcer disease (“GUD”).

Key Points: 
  • This novel Labquality EQA program will help ensure the proficiency of clinical labs testing to diagnose the pathogens that cause GUD.
  • In turn, Labquality has designed and is managing this GUD-oriented EQA program – which is now offered to labs in 60 countries.
  • Juha Wahlstedt, Sales Director at Labquality, commented, “We’re pleased to be employing Microbix’s innovative QAPs for this new and important EQA program.
  • Our expertise was joined to that of Labquality and Copan to ensure accurate testing and properly-directed treatment is widely available for GUD patients.”

Gonorrhoea and syphilis diagnoses are at their highest in decades – here's what you need to know about these STIs

Retrieved on: 
Saturday, June 10, 2023
Infection, Vagina, UK Health Security Agency, Pelvic inflammatory disease, Neisseria gonorrhoeae, Penis, STI, Syphilis, Deafness, Fever, Urethra, Congenital syphilis, Skin, Incontinence, Woman, Paratriathlon, Prostate, Abdominal pain, DSM-IV codes, Partner (business rank), Gonorrhea, Pain, Treponema pallidum, Man, Dementia, Time, Vaginal discharge, Risk, Child, Chronic pain, Security agency, Ulcer, Stillbirth, Chlamydia, Water, Ageing, Pregnancy, Diagnosis, Condom, Disease, Pharmaceutical industry, Birth control, Antibiotics, Treponema

Shockingly, gonorrhoea rates are the highest they have been since records began in 1918.

Key Points: 
  • Shockingly, gonorrhoea rates are the highest they have been since records began in 1918.
  • Gonorrhoea has increased from 71,133 diagnoses per year before the pandemic to 82,592 in 2022.
  • Syphilis, which in the early 2000s was almost non-existent in the UK, has increased to 8,692 diagnoses in 2022.

What symptoms do they cause?

    • In women symptoms can be less obvious, but include a watery, green, yellow or sometimes bloodstained vaginal discharge, and pain when urinating.
    • Symptoms include fever and abdominal pain.
    • For this reason, it’s essential to get diagnosed and treated if you’re experiencing any symptoms.
    • The disease now enters a latent phase where it stays in the body while showing no symptoms.
    • This causes a range of symptoms which were dreaded in the years before effective treatment – including skin and bone disfigurations, nerve pain, heart problems, deafness, blindness, dementia and other neurological symptoms such as difficulty walking and incontinence.

Why have rates increased?

    • It’s not entirely clear why rates of syphilis and gonorrhoea have increased so rapidly in the UK.
    • Data shows that rates of gonorrhoea in particular are sensitive to social and political change, including changes to funding for sexual health services.

What can I do to protect myself?

    • If you have a symptom you’re worried about, get it checked.
    • Self-test kits for gonorrhoea and syphilis are available online in some areas or you can go to a sexual health clinic if you prefer.

Chembio Announces the Receipt of CLIA Waiver for its DPP HIV-Syphilis System

Retrieved on: 
Friday, February 24, 2023
Infection, STD, Bacteria, HIV, Stillbirth, CDC, Diagnosis, Congenital syphilis, Clinical Laboratory, Pregnancy, Health, Disease, Infant, Risk, Syphilis, Treponema pallidum, FDA, Patient, DPP, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CLIA, Child, Plasma, Coinfection, Birth defect, APRN, Human services, U.S. Department of Defense Strategy for Operating in Cyberspace, Temperature, Antibody, DNP, Fetus, Woman, Food, Pharmaceutical industry, Treponema

MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the DPP HIV-Syphilis System.

Key Points: 
  • MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the DPP HIV-Syphilis System.
  • “The DPP HIV-Syphilis System represents an exciting advancement in rapid testing for sexually transmitted infections.
  • Chembio’s DPP HIV-Syphilis System assists clinicians in diagnosing both HIV and syphilis while patients are still under care at the testing location.
  • The DPP HIV-Syphilis System is highly sensitive and specific, has a built-in procedural control, can be stored at room temperature, and has a 24-month shelf life.

Chembio Announces FDA CLIA Waiver Submission for DPP HIV-Syphilis System

Retrieved on: 
Monday, November 28, 2022
COVID-19, Infection, Vertically transmitted infection, Government, Diagnosis, CDC, Antibody, Food, Blood, Risk, Hospital, EUA, Bacteria, Infant, ANVISA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pregnancy, Patient, System, Annual report, Birth defect, PMA, CLIA, Disease, World Health Organization, DPP, Treponema pallidum, Clinical Laboratory, Coinfection, Sale, Fetus, Stillbirth, CE marking, Congenital syphilis, Woman, HIV, Syphilis, Plasma, FDA, Pharmaceutical industry, Treponema

We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver.

Key Points: 
  • We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver.
  • Upon receipt of CLIA waiver, we believe this will represent a large step forward in rapid testing for sexually transmitted infections.
  • We appreciate the collaboration with the FDA on this submission and look forward to continued dialog regarding our CLIA waiver application, said RichardL.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

Global Syphilis Testing Market Report to 2028 - Increasing Government Funding or Investments on STD Testing is Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, November 21, 2022
Infectious Diseases, Pharmaceutical, Health, Medical Devices, Patient, Investment, STD, Syphilis, Yaws, Pinta, NGO, Government, Human, Social media, Fear, Treponema pallidum, Rectum, Immune system, Chancre, Person, Disease, Location, Stigma, Sore, Health, Pharmaceutical industry, Risk management, Treponema

The "Global Syphilis Testing Market Size, Share & Industry Trends Analysis Report By Type, By Location of Testing testing), By Regional Outlook and Forecast, 2022 - 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Syphilis Testing Market Size, Share & Industry Trends Analysis Report By Type, By Location of Testing testing), By Regional Outlook and Forecast, 2022 - 2028" report has been added to ResearchAndMarkets.com's offering.
  • The Global Syphilis Testing Market size is expected to reach $1.5 billion by 2028, rising at a market growth of 5.6% CAGR during the forecast period.
  • The early phase of syphilis is the concealed, or latent, stage, during which the patient is unaffected.
  • Utilizing the social media platforms and the various campaigns by the NGO and various authorities are making people aware about the Syphilis testing market.

Chembio Diagnostics Awarded $3.2 Million Contract from the CDC for Development and Clinical Validation of Dual-Path Platform Syphilis Screen & Confirm Assay

Retrieved on: 
Tuesday, September 6, 2022
DPP, COVID-19, Technology, Research, Syphilis, U.S. Securities and Exchange Commission, CLIA, Antibody, GLOBE, Â, POC, CDC, Patient, EUA, CE marking, Vertically transmitted infection, World, Serum, ANVISA, FDA, Confirmation, Disease, Biological Technologies Office (DARPA), Treponema pallidum, Immunoglobulin M, Blood, Infant, Hospital, Pregnancy Outcome Prediction (POP) study, HIV, Science and technology, PMA, Korea Disease Control and Prevention Agency, Serology, Immunoglobulin G, Private Securities Litigation Reform Act, Transport, Government, Infection, Policy, Congenital syphilis, Physician, Diagnosis, Center, Plasma, Annual report, Forward-looking statement, World Health Organization, Medical device, Vaccine, Pharmaceutical industry

Chembio will undertake to develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and proprietary DPP Micro Reader II.

Key Points: 
  • Chembio will undertake to develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and proprietary DPP Micro Reader II.
  • Chembio has previous experience in the field of rapid syphilis diagnostics through its successful development, validation, and commercialization of DPP HIV-Syphilis.
  • The Chembio DPP HIV-Syphilis Assay is a rapid serologic test for the detection of antibodies to HIV and/or the causative agent of syphilis, Treponema pallidum.
  • Additionally, Chembio has worked to develop a DPP Syphilis Screen and Confirm test, using a CDC licensed reagent with improved liposomal preparation on the nontreponemal test line.

Microbix Presenting STI Multiplex Test Controls at AACC

Retrieved on: 
Tuesday, July 26, 2022
Goal, TSX, Association, Diagnosis, STI, Vertically transmitted infection, GLOBE, Genital ulcer, Treponema pallidum, U.S. FDA, QAP, Laboratory, TGA, ISO 9001, Herpes simplex virus, Health, American Association, Health Canada, Ulcer, QAP (Colombia), News, Organization, CE, American Association for Clinical Chemistry, GUD, AACC, Company, FDA, Poster, Engineering, Antigen, Medical device, OTCQX, Vaccine, Treponema

GUDs are a current and growing global health concern, with over 20 million new cases each year.

Key Points: 
  • GUDs are a current and growing global health concern, with over 20 million new cases each year.
  • Microbix has overcome challenges in formulation and appears to be the first to develop a multiplex whole-workflow control for GUD assays.
  • Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching C$ 2.0 million per month.
  • Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.

Flightpath Licenses the First Antibiotic that Selectively Kills Lyme Disease Spirochetes

Retrieved on: 
Wednesday, October 6, 2021
Health, Infectious Diseases, Research, Pharmaceutical, Science, Biotechnology, Biotechnology, Infection, Probability, Borrelia burgdorferi, Pressure, Therapy, Lyme disease, Cancer, Patient, Microbiology, Coronavirus Scientific Advisory Board (Turkey), Population, LinkedIn, Bacteria, Doxycycline, Toxicity, List of life sciences, Diabetes, Chronic Lyme disease, Disease, Risk, Treponema pallidum, Research, Conditional sentence, Obesity, Amoxicillin, Pharmaceutical industry, Vaccine, Antibiotics

Flightpath Biosciences, Inc , a biotechnology company advancing microbiome-sparing therapeutics and diagnostics for infectious diseases, licensed a developmental antibiotic FP-100 acting selectively against a range of spirochetal pathogens from Northeastern University.

Key Points: 
  • Flightpath Biosciences, Inc , a biotechnology company advancing microbiome-sparing therapeutics and diagnostics for infectious diseases, licensed a developmental antibiotic FP-100 acting selectively against a range of spirochetal pathogens from Northeastern University.
  • The lead author, Dr. Kim Lewis, is a co-founder and member of the Scientific Advisory Board of Flightpath.
  • The research demonstrates that FP-100 is actively transported into the cell of Borrelia burgdorferi, the bacteria that causes Lyme disease, leading to highly potent and selective killing.
  • The company recently graduated from the Illumina Accelerator and completed the largest and most comprehensive clinical biomarker study ever in Chronic Lyme Disease.

Global Treponema Pallidum Tests (In Vitro Diagnostics) Market Analysis and Forecast Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, April 26, 2021
Medical devices, Health, Syphilis, Business process, Treponema, Treponema pallidum, Articles, Market segmentation, Marketing strategy, Marketing, Medical specialties

b'Key Inclusions of the market model are:\nInsightful review of the key industry trends.\nAnnualized total Treponema Pallidum Tests market revenue by segment and market outlooks from 2015-2030.\nGranular data on total procedures, units, average selling prices and market values by segment.\nQualitative market specific information is available with global trends further broken down into regional trends.

Key Points: 
  • b'Key Inclusions of the market model are:\nInsightful review of the key industry trends.\nAnnualized total Treponema Pallidum Tests market revenue by segment and market outlooks from 2015-2030.\nGranular data on total procedures, units, average selling prices and market values by segment.\nQualitative market specific information is available with global trends further broken down into regional trends.
  • In addition, analysts provide unique country specific insights on the market.\nSWOT analysis for Treponema Pallidum Tests market.\nCompetitive dynamics insights and trends provided for Treponema Pallidum Tests market.\nDrive the understanding of the market by getting the veritable big picture including an overview of the healthcare system.
  • In addition the Market Access segment allows you to delve deeper into market dynamics with information on reimbursement policies and the regulatory landscape.\nCountry specific overview of the healthcare system.\nCountry specific medtech regulatory landscape.\nCMO executives who must have deep understanding of the Treponema Pallidum Tests market place to make strategic planning and investment decisions.\nSourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.\nPrivate equity investors that need a deeper understanding of the market to identify and value potential investment targets.\nUnderstand the impact of COVID-19 on Treponema Pallidum Tests market.\nDevelop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.\nDevelop business strategies by understanding the trends shaping and driving Treponema Pallidum Tests market.\nDrive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the Treponema Pallidum Tests market in the future.\nFormulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the company share of market leaders.\nIdentify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.\nTrack device sales in the global and country-specific Treponema Pallidum Tests market from 2015-2030.\nOrganize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210426005434/en/\n'