Mycoplasma

SpeeDx Receives Clearance for COVID-19 Diagnostic Test

Retrieved on: 
Wednesday, August 11, 2021

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.

Environmental Lab Experiment Shows Masks May Elevate Carbon Dioxide and Bacteria Levels

Retrieved on: 
Tuesday, August 10, 2021

Using a simple experiment with one subject wearing an N95 mask, EDLab tested total volatile organic compounds (TVOC's), carbon dioxide levels, temperature, relative humidity, and microbial concentration in the micro-environment in and around the mask worn by the subject.

Key Points: 
  • Using a simple experiment with one subject wearing an N95 mask, EDLab tested total volatile organic compounds (TVOC's), carbon dioxide levels, temperature, relative humidity, and microbial concentration in the micro-environment in and around the mask worn by the subject.
  • When compared with the surrounding indoor air environment, the lab found within the mask increased levels of TVOC's (76%), carbon dioxide (459%), humidity (80%) and temperature (10%).
  • Microbial concentration (Staphylococcus epidermidis) was tested within the mask before and after the subject wore it during the experiment, resulting in a post-wearing increase of 110%.
  • "The effects of breathing elevated levels of carbon dioxide are well known and could have health implications.

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

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.

Chembio Diagnostics Receives $4 Million HIV Test Purchase Order Supported by The Global Fund

Retrieved on: 
Thursday, July 22, 2021

Chembios delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembios supply chain, staffing, and liquidity, and other matters outside Chembios control.

Key Points: 
  • Chembios delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembios supply chain, staffing, and liquidity, and other matters outside Chembios control.
  • Chembio was first awarded the front-line testing algorithm position in Ethiopia in 2018 to screen for HIV.
  • Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted, respiratory and insect vector diseases.
  • Forward-looking statements include statements regarding the intent, belief or current expectations with respect to manufacturing, distribution, and sale of the HIV 1/2 STAT-PAK Assay pursuant to the purchase order from PFSCM.

Femasys Inc. Announces First Patient Treated in Pivotal Trial for FemaSeed

Retrieved on: 
Tuesday, July 20, 2021

LOCAL Pivotal Trial to Enroll Up to 792 Patients Across 20 U.S. Centers

Key Points: 
  • LOCAL Pivotal Trial to Enroll Up to 792 Patients Across 20 U.S. Centers
    ATLANTA, July 20, 2021 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on transforming women's healthcare, today announced the initiation and first patient treated in a pivotal trial evaluating FemaSeed, a first in class, localized directional insemination product candidate for infertility.
  • The LOCAL trial is the next step in proving the FemaSeed localized directional insemination approach.
  • My colleagues and I are thrilled to be a part of this patient care evolution.
  • The LOCAL trial will be conducted across approximately 20 centers in the United States and is expected to enroll up to 792 patients diagnosed as infertile.

LexaGene’s MiQLab Detects Common Bioreactor Contaminant up to 300 Times Faster than Conventional Methods

Retrieved on: 
Tuesday, July 20, 2021

Last month, LexaGene announced it could detect Cutibacterium acnes 36 to 168 times faster than conventional methods.

Key Points: 
  • Last month, LexaGene announced it could detect Cutibacterium acnes 36 to 168 times faster than conventional methods.
  • We expect the time benefit of MiQLab Mycoplasma Test to be up to 300 times faster than conventional methods.
  • LexaGenes results demonstrate that the MiQLab system can serve as a valid alternative to lengthy traditional methods for mycoplasma detection.
  • Given the MiQLab can be up to 300 times faster than traditional culture testing (~2 hours versus ~28 days) for a definitive result, the MiQLab can provide a significant time advantage for biopharmaceutical manufacturers.

MedAnswers and Organic Conceptions Ink Partnership to Deliver Emotional Health Insights to the FertilityAnswers App Community

Retrieved on: 
Monday, July 12, 2021

With its robust data analytics MedAnswers provides a customized, emotional health insight report to its community of highly-engaged fertility users based on their FertilQol survey results.

Key Points: 
  • With its robust data analytics MedAnswers provides a customized, emotional health insight report to its community of highly-engaged fertility users based on their FertilQol survey results.
  • More than half of the FertilityAnswers community does not have access to adequate mental health services specific to infertility.
  • Marc Sherman, Organic Conceptions CEO adds, The FertilityAnswers app is a trusted resource among the community struggling with fertility issues.
  • The FertilityAnswers App will now include the Organic Conceptions approach as an option when matched through the proprietary algorithm.

Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) for the Treatment of Trichomoniasis

Retrieved on: 
Thursday, July 1, 2021

[1] SOLOSEC was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women.

Key Points: 
  • [1] SOLOSEC was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women.
  • The supplemental approval makes SOLOSEC the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.
  • Research demonstrates that approximately 70% of women with trichomoniasis are PCR positive for BV,[2]" said Jon Stelzmiller, President Specialty, Lupin Pharmaceuticals, Inc.
  • SOLOSEC(secnidazole) 2 g oral granules is an antimicrobial agent indicatedfor the treatment of BV in adult women and trichomoniasis in adults.

AHF Launches New Campaigns “Hook Up With Us” Addressing 6th Straight Year of Increases in STDs and “AHF Is Resilience”

Retrieved on: 
Saturday, June 19, 2021
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210619005059/en/
    In 2019, more than 2.5 million cases of chlamydia, gonorrhea, and syphilis were reported, and were the most common STDs found.
  • Undoubtedly, this causes grave concern as STDs have the potential to lead to serious health consequences, especially if untreated.
  • Past AHF billboard campaigns addressing STDs include Gonorrhea Alert , launched in June of 2018 which was a nationwide effort to educate the public about a drug-resistant strain of the STD.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare .

Allison Petrini, M.D., Joins Texas Fertility Center After REI Fellowship at Cornell

Retrieved on: 
Tuesday, June 15, 2021

Austin, Texas, June 15, 2021 (GLOBE NEWSWIRE) -- Texas Fertility Center proudly announces that Allison Petrini, M.D., will join the practice as a fertility specialist in Austin.

Key Points: 
  • Austin, Texas, June 15, 2021 (GLOBE NEWSWIRE) -- Texas Fertility Center proudly announces that Allison Petrini, M.D., will join the practice as a fertility specialist in Austin.
  • Dr. Petrini will join the five doctors at Texas Fertility Center Austin to diagnose and treat the various causes of male and female infertility.
  • According to Texas Fertility Center Medical Director Kaylen Silverberg, M.D., We are excited to have Dr. Petrini officially join Texas Fertility Center.
  • Dr. Petrini offers compassionate and customized fertility treatment to all patients, which is a hallmark of Texas Fertility Center care.