Mycoplasma genitalium

GeneProof Announces Expansion of its IVDR-Certified PCR Portfolio

Retrieved on: 
Tuesday, October 3, 2023
Ureaplasma urealyticum, CT, IVDR, Urinary tract infection, Workflow, CP, Infection, Neisseria gonorrhoeae, Chlamydia trachomatis, Real-time, Quality management system, Mycoplasma genitalium, Mycoplasma hominis, NG, Canine vector-borne disease, Diagnosis, PCR, Chlamydia pneumoniae, Medical device, Telecommunications, Ureaplasma, EU, Mycoplasma, Chlamydia

BRNO, Czech Republic, Oct. 3, 2023 /PRNewswire/ -- GeneProof, a leader in molecular diagnostics, today announced the addition of six new IVDR-certified PCR kits to its expansive portfolio.

Key Points: 
  • BRNO, Czech Republic, Oct. 3, 2023 /PRNewswire/ -- GeneProof, a leader in molecular diagnostics, today announced the addition of six new IVDR-certified PCR kits to its expansive portfolio.
  • This comes as a testament to the company's dedication to delivering its entire portfolio of approximately 80 products as IVDR compliant by 2027.
  • Currently, 27 products are IVDR cleared, with 16 that are Notified Body certified in class C and B.
  • GeneProof was among the first to obtain the EU Certificate for Quality Management System under the new Regulation (EU) 2017/746 IVDR.

Microbix Presents Results of STI Test Controls at AACC

Retrieved on: 
Monday, July 24, 2023
CT, AACC, STI, Trichomonas vaginalis, Abbott, Vertically transmitted infection, QAP (Colombia), Emerging, PCR, Point-of-care testing, Infection, Neisseria gonorrhoeae, Mycoplasma, Chlamydia trachomatis, BD, Assay, RUO, Gertrude Pocte Geddes Willis, American Association for Clinical Chemistry, NG, Mycoplasma genitalium, OTCQX, IVD, TSX, Poster, Medical imaging, Chlamydia, Trichomonas

At AACC, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases.

Key Points: 
  • At AACC, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases.
  • Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and molecular (i.e., “PCR”) tests and their workflows.
  • Microbix therefore developed a whole-workflow multiplex STI QAP desiccated on a Copan FLOQSwab® that is stable at 2-30°C and contains inactive whole-genome target pathogens.
  • We’re pleased to be offering Microbix QAPs to support clinically-important STI testing – as tools for validation, verification, and training, as external quality assessment samples, and as in-kit controls.”

Microbix Presents Results of STI Test Controls at ASM Microbe

Retrieved on: 
Tuesday, June 13, 2023
Pelvic inflammatory disease, STI, Infection, QAP, Infertility, Urethritis, AMR, RUO, Buffer, Mycoplasma genitalium, OTCQX, IVD, TSX, Poster, Cervicitis, American Society for Microbiology, Society, Vaccine, MGEN

At ASM Microbe, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases.

Key Points: 
  • At ASM Microbe, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases.
  • Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and nucleic acid (i.e., “PCR”) tests and their workflows.
  • Using innovative and proprietary methods, Microbix created and manufactured such materials – including for five AMR variants of Mgen.
  • Formatted onto COPAN® FLOQSwabs®, the resulting Microbix QAPs were then used to validate and support novel tests for AMR detection, namely the SpeeDx Pty.

Thermo Fisher Scientific Launches TrueMark STI Select Panel

Retrieved on: 
Wednesday, February 8, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Research, Infectious Diseases, Alternative Energy, Environment, Energy, Science, STI, Thermo Fisher Scientific, Neisseria gonorrhoeae, Applied Biosystems, Korea Disease Control and Prevention Agency, Mycoplasma, PCR, MagMax, Genetic testing, Trichomonas vaginalis, Ribonuclease P, Chlamydia trachomatis, CDC, Syphilis, Genetic, Gonorrhea, Polymerase chain reaction, Mycoplasma genitalium, Vaccine, Neisseria, Chlamydia, Trichomonas

Thermo Fisher Scientific, the world leader in serving science, today announced the launch of its Applied Biosystems TrueMark STI Select Panel, a polymerase chain reaction (PCR) research use only test designed to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium in one test, as well as RNase P, included as a human internal control.

Key Points: 
  • Thermo Fisher Scientific, the world leader in serving science, today announced the launch of its Applied Biosystems TrueMark STI Select Panel, a polymerase chain reaction (PCR) research use only test designed to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium in one test, as well as RNase P, included as a human internal control.
  • The Applied Biosystems TrueMark STI Select Panel simultaneously tests for the four common STIs on the same panel, helping labs save time that would have been otherwise needed to run each on their own.
  • The TrueMark STI Select Panel is sold as a combo kit, which includes the STI panel assay and master mix; positive controls are also included for added accuracy and efficiency.
  • For more information on Thermo Fisher’s TrueMark STI Panel, please visit: https://www.thermofisher.com/truemarkstiselectpanel
    For Research Use Only.

Favor Teams Up with imaware to Offer Discrete At-Home STI Tests to Women and People Who Menstruate

Retrieved on: 
Thursday, August 18, 2022
Woman, Reproductive health, MG, Biomarker, Chlamydia, CEO, GLOBE, Simplex, College, Syphilis, Technology, Telehealth, Prevalence, STI, Congenital syphilis, American Journal, Patient, CDC, COVID-19, Ureaplasma urealyticum, Gonorrhea, Preventive healthcare, Men's Health, Coronavirus, CAP, HIPAA, Mycoplasma genitalium, Clinical Laboratory Improvement Amendments, Trichomoniasis, American Journal of Preventive Medicine, Insurance, Digital, Solution, Degenerative disease, CLIA, Health, Birth control, Pharmaceutical industry

“Favor deeply understands women’s health and how unique each patient’s journey can be. STI testing is more than just a box and what’s inside; it’s critical to understand the worries and challenges that patients face when they go to get tested -- from cost of testing to sensitivities around discretion,” said Jani Tuomi, founder of imaware. “imaware was created to make scientifically validated tools for screening and monitoring health more accessible and convenient and we are extremely proud to be partnering with Favor, a company closely aligned with our own mission.”

Key Points: 
  • This custom, one-of-a-kind test kit goes beyond existing at-home STI tests on the market to provide women and people who menstruate with a more comprehensive and accurate picture of their reproductive health.
  • The STI test, and customer experience, leverages advanced capabilities of imaware, a leader in testing technology and digital health.
  • As an antidote to the screening gap, imaware has developed its first at-home STI test that is accessible, convenient and accurate.
  • Favor is the nations leading integrated digital healthcare platform on a mission to empower women and people who menstruate to lead their healthiest lives.

Abbott Obtains FDA Clearance for First Test that Simultaneously Detects Four Common Sexually Transmitted Infections (STIs) as Cases are on the Rise

Retrieved on: 
Wednesday, May 4, 2022
Aline (song), COVID-19, Pandemic, Population, HIV, Incidence, Twitter, STI, Neisseria gonorrhoeae, Mycoplasma genitalium, Sexually transmitted infection, Human services, NYSE, Nutritional challenges of HIV/AIDS, Time, HBV, CDC, PCR, Patient, Projected, HIV-1, Becker, Infection, Polymerase chain reaction, Syphilis, Geography, STD, CT, FDA, Chlamydia trachomatis, Hepatitis, HCV, American Journal of Preventive Medicine, Hepatitis B, Center, Journal, Workflow, The Journal of Infectious Diseases, Severe acute respiratory syndrome coronavirus 2, Efficiency, Korea Disease Control and Prevention Agency, Gonorrhea, United States Department of Health and Human Services, Trichomonas vaginalis, LinkedIn, NG, Life, Technology, Emergency Use Authorization, Cancer, Mycoplasma, Risk, Birth control, Pharmaceutical industry, Vaccine, Chlamydia, Trichomonas

The test simultaneously detects and differentiates four common sexually transmitted infections (STIs).

Key Points: 
  • The test simultaneously detects and differentiates four common sexually transmitted infections (STIs).
  • The test runs on Abbott's Alinity m system the company's most advanced high-volume laboratory molecular instrument.
  • This test can help healthcare providers save time, increase efficiency and better serve patients.
  • CDC estimates 1 in 5 people in the U.S. have a sexually transmitted infection, https://www.cdc.gov/media/releases/2021/p0125-sexualy-transmitted-infect...
    5.

SpeeDx Receives Clearance for COVID-19 Diagnostic Test

Retrieved on: 
Wednesday, August 11, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Genetics, Severe acute respiratory syndrome coronavirus 2, Center, Viral pneumonia, COVID-19, Mutation, Infection, Mycoplasma, TGA, VOC, Database, STI, Real-time, Centers for Disease Control and Prevention, VOI, Workflow, Research, Technology, Robotics, Mycoplasma genitalium, March v Stramare (E & MH) Pty Ltd, Gonorrhea, Pharmaceutical industry, Vaccine, Animal

Ltd. announced today their PlexPCR SARS-CoV-2* test received clearance from the Australian Therapeutic Goods Administration (TGA).

Key Points: 
  • Ltd. announced today their PlexPCR SARS-CoV-2* test received clearance from the Australian Therapeutic Goods Administration (TGA).
  • The test is ideally suited to support rapid response to outbreaks, offering scalable 96- or 384-well capacity, automated software reporting, and liquid handling robotics in the form of the SpeeDx PlexPrep.
  • Ideal to support surges in test demand with throughputs of up to 1,920 patient samples in an 8 hour shift.
  • SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management.

New CDC Guidelines Endorse Opt-Out Screening for Two of the Most Common Sexually Transmitted Infections (STIs), Recommend Nucleic Acid Testing for Mycoplasma Genitalium

Retrieved on: 
Monday, July 26, 2021
Medical devices, Medical Supplies, Women, Infectious diseases, Biotechnology, AIDS, Health, Consumer, General Health, Sexually transmitted diseases and infections, Medical specialties, Clinical medicine, Infectious causes of cancer, Medicine, Mycoplasma, Synthetic biology, Mycoplasma genitalium, Urethritis, Cervicitis, Nucleic acid test, Protein M

For the first time, CDC guidelines also defined specific populations (men with recurrent urethritis and women with recurrent cervicitis) to be tested for Mycoplasma genitalium and recommended nucleic-acid amplification testing (NAAT) for detection.

Key Points: 
  • For the first time, CDC guidelines also defined specific populations (men with recurrent urethritis and women with recurrent cervicitis) to be tested for Mycoplasma genitalium and recommended nucleic-acid amplification testing (NAAT) for detection.
  • The 2015 CDC guidelines included M. genitalium as an emerging issue, but no FDA-cleared NAATs were available at that time11.
  • Hologic was first to market in 2019 with a NAAT for M. genitalium, and Hologics Aptima Mycoplasma genitalium Assay is specifically noted in the current guidelines1.
  • No FDA-cleared M. genitalium tests are available in the U.S. that detect antibiotic resistance, although Hologic is working to develop one.

European Launch of ResistancePlus MG FleXible for the GeneXpert System

Retrieved on: 
Monday, December 16, 2019
Biotechnology, Health, Medical Supplies, Medical devices, Mycoplasma, Sexually transmitted diseases and infections, Infectious causes of cancer, RTT, Medical specialties, Organisms, Clinical medicine, Pathogenic bacteria, Mycoplasma genitalium, MGEN, GeneXpert MTB/RIF, MG

SpeeDx Pty, Ltd. today announced the European launch of ResistancePlus MG FleXible, the first sample-to-answer test for detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance.

Key Points: 
  • SpeeDx Pty, Ltd. today announced the European launch of ResistancePlus MG FleXible, the first sample-to-answer test for detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance.
  • Cepheid is the exclusive distribution partner of this test, available through Cepheids FleXible Cartridge programme for the GeneXpert System.
  • View the full release here: https://www.businesswire.com/news/home/20191215005039/en/
    ResistancePlus MG FleXible is now selling in France and the U.K. (to be followed by rest of EU, Australia and New Zealand).
  • ResistancePlus MG FleXible enables Resistance Guided Therapy, supporting more clinicians to adhere to testing guidelines and maximising effective care for their patients infected with Mgen.

Newly Published Research Demonstrates Ability of Hologic’s Assay to Detect Mycoplasma Genitalium, “the Silent Epidemic”

Retrieved on: 
Monday, November 11, 2019
Health, Infectious diseases, General Health, Research, Science, Biotechnology, Infectious causes of cancer, Sexually transmitted diseases and infections, Biostatistics, Natural sciences, Organisms, Physical sciences, Synthetic biology, Mycoplasma genitalium, Assay, Mycoplasma, Positive and negative predictive values, Sexually transmitted infection

A newly published study demonstrates clinical evidence for the effectiveness of a first-of-its-kind, FDA-cleared assay for the detection of the sexually transmitted bacterium Mycoplasma genitalium (M. genitalium).

Key Points: 
  • A newly published study demonstrates clinical evidence for the effectiveness of a first-of-its-kind, FDA-cleared assay for the detection of the sexually transmitted bacterium Mycoplasma genitalium (M. genitalium).
  • Subjects were enrolled at STI clinics, clinical research centers, and emergency medicine, family planning, public health, STI and family medicine/obstetric-gynecologic sites.
  • The study evaluated prevalence, sensitivity, specificity, positive predictive value, and negative predictive value for the Aptima assay compared to a composite molecular reference standard.
  • Results showed that for each of seven specimen types, Aptima assay results aligned closely with results obtained with the composite reference standard.