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Quest Diagnostics' (DGX) New Study Exposes Alarming Data on STI
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Quest Diagnostics (DGX - Free Report) , in collaboration with the University of Alabama, conducted a study that suggests adherence to guideline-based laboratory testing and treatment of pregnant women for two of the most prevalent sexually transmitted infections (STIs) is suboptimal in the United States. This could potentially result in dire effects on maternal and newborn health.
The study, titled “Chlamydia and gonorrhea testing in pregnancy: Time to improve adherence and update recommendations”, was published in the peer-reviewed Journal of Lower Genital Tract Disease — the official journal of the American Society for Colposcopy and Cervical Pathology. It is based on deidentified results of lab tests performed in all 50 states and the District of Columbia for more than four million pregnancies.
More on the Study and Findings
Per key findings, more than 4% of women who received guideline-based screening for chlamydia or gonorrhea in pregnancy during the first trimester received a positive result for one or both infections. Among these, more than one in three (35.1% chlamydia and 36.9% gonorrhea) did not receive a follow-up negative test before delivery. This reflects a possibility that they may not have been treated and cured or were treated and cured but then reinfected before birth.
Furthermore, nearly 2% of patients who received a negative test result for chlamydia or gonorrhea early in pregnancy later tested positive, suggesting a persistent risk of infection during pregnancy. Of these patients, about one in two (53% chlamydia and 49.3% gonorrhea) remained positive prior to delivery.
The findings reveal gaps in guideline-based care intended to reduce the risk of infection and medical complications. Untreated chlamydia and gonorrhea can lead to heightened risks of infertility and pelvic inflammatory disease in women. The chance of transmission during birth is approximately 50%, raising the potential for newborns to develop infections of the eye (conjunctivitis), lungs (pneumonia) and other health problems.
While the study benefits from its large size, national representation and use of objective laboratory data, it lacks the clinical follow-up information for the positive cases as testing was limited to one national clinical laboratory. The authors did not evaluate other STIs, such as syphilis. However, they caution that these patterns of irregular adherence to guideline-based testing in maternal care may extend to other conditions.
Conclusions of the Study
The authors of the study believe that reinfections (or ineffectively treated initial infections) may lead to more deliveries while women are positive for one or more STIs, affecting both maternal and newborn health. They also concluded that current guidelines are inconsistent and proposed several recommendations for improvements. For instance, the Centers for Disease Control and Prevention (“CDC”) recommends women be retested for cure at four weeks of pregnancy, while the USPSTF recommends retesting before three weeks.
Additionally, the present guidelines do not recommend screening women after the age of 25 years unless there are risk factors (such as multiple partners) based on much earlier data from 1988.
The guidelines recommend that all women under the age of 25 be screened, regardless of perceived risk.According to the CDC, the cases of sexually transmitted diseases are at an all-time high, with more than 2.5 million cases of syphilis, gonorrhea and chlamydia reported in the United States in 2022.
Industry Prospects
Per a report by Grand View Research, the global STI testing market was valued at $10.1 billion in 2023 and is expected to witness a CAGR of 7.2% by 2030. The market is primarily influenced by advancements in diagnostic technology and increased government efforts to promote early detection and treatment.
Updates From Peers
Within the broader MedTech industry, several key players are involved in STI testing and diagnostics. These companies are also making other notable developments in their respective businesses.
Women’s health-focused company, Hologic (HOLX - Free Report) , dominates the U.S. markets for STI testing and is well-positioned to capture a larger share internationally. Last month, it acquired Endomagnetics Ltd (Endomag), the UK-based developer of breast cancer surgery technologies, in a transaction valued at approximately $310 million. The latter’s wireless breast surgery localization and lymphatic tracing solutions, including the Magseed marker, the Magtrace lymphatic tracer and the Sentimag platform, will complement and diversify Hologic’s expanding interventional breast health portfolio.
Renowned for its Sample to Insight solutions, QIAGEN (QGEN - Free Report) provides a range of STI tests through its Sexual & Reproductive Health portfolio, including tests for Chlamydia trachomatis and Neisseria gonorrhoeae infections. The company recently collaborated with the University of Montana to drive the implementation of next-generation sequencing and forensic investigative genetic genealogy in identifying human remains.
Furthermore, it introduced 35 new wet-lab-tested digital PCR Microbial DNA Detection Assays for the QIAcuity digital PCR platform. These assays target pathogens responsible for tropical diseases, STIs and urinary tract infections, further solidifying the company’s leadership in microbial detection and analysis.
Another peer, Thermo Fisher Scientific (TMO - Free Report) , offers several types of manual, automated or semi-automated in vitro diagnostic STI test kits and other STI testing products. The company’s SeCore CDx HLA A Sequencing System was recently granted the FDA 510(k) clearance as a companion diagnostic for Adaptimmune’s TECELRA (afamitresgene autoleucel) T-cell receptor therapy for unresectable or metastatic synovial sarcoma.
TMO also introduced a novel pre-transplant risk assessment (PTRA) assay that helps assess the risk of early acute rejection in kidney transplant recipients. The One Lambda PTR Assay is the first test of its kind, aiming to help inform clinical decision-making and support more personalized patient management, with the ultimate aim of improving outcomes.
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Quest Diagnostics' (DGX) New Study Exposes Alarming Data on STI
Quest Diagnostics (DGX - Free Report) , in collaboration with the University of Alabama, conducted a study that suggests adherence to guideline-based laboratory testing and treatment of pregnant women for two of the most prevalent sexually transmitted infections (STIs) is suboptimal in the United States. This could potentially result in dire effects on maternal and newborn health.
The study, titled “Chlamydia and gonorrhea testing in pregnancy: Time to improve adherence and update recommendations”, was published in the peer-reviewed Journal of Lower Genital Tract Disease — the official journal of the American Society for Colposcopy and Cervical Pathology. It is based on deidentified results of lab tests performed in all 50 states and the District of Columbia for more than four million pregnancies.
More on the Study and Findings
Per key findings, more than 4% of women who received guideline-based screening for chlamydia or gonorrhea in pregnancy during the first trimester received a positive result for one or both infections. Among these, more than one in three (35.1% chlamydia and 36.9% gonorrhea) did not receive a follow-up negative test before delivery. This reflects a possibility that they may not have been treated and cured or were treated and cured but then reinfected before birth.
Furthermore, nearly 2% of patients who received a negative test result for chlamydia or gonorrhea early in pregnancy later tested positive, suggesting a persistent risk of infection during pregnancy. Of these patients, about one in two (53% chlamydia and 49.3% gonorrhea) remained positive prior to delivery.
The findings reveal gaps in guideline-based care intended to reduce the risk of infection and medical complications. Untreated chlamydia and gonorrhea can lead to heightened risks of infertility and pelvic inflammatory disease in women. The chance of transmission during birth is approximately 50%, raising the potential for newborns to develop infections of the eye (conjunctivitis), lungs (pneumonia) and other health problems.
While the study benefits from its large size, national representation and use of objective laboratory data, it lacks the clinical follow-up information for the positive cases as testing was limited to one national clinical laboratory. The authors did not evaluate other STIs, such as syphilis. However, they caution that these patterns of irregular adherence to guideline-based testing in maternal care may extend to other conditions.
Conclusions of the Study
The authors of the study believe that reinfections (or ineffectively treated initial infections) may lead to more deliveries while women are positive for one or more STIs, affecting both maternal and newborn health. They also concluded that current guidelines are inconsistent and proposed several recommendations for improvements. For instance, the Centers for Disease Control and Prevention (“CDC”) recommends women be retested for cure at four weeks of pregnancy, while the USPSTF recommends retesting before three weeks.
Additionally, the present guidelines do not recommend screening women after the age of 25 years unless there are risk factors (such as multiple partners) based on much earlier data from 1988.
The guidelines recommend that all women under the age of 25 be screened, regardless of perceived risk.According to the CDC, the cases of sexually transmitted diseases are at an all-time high, with more than 2.5 million cases of syphilis, gonorrhea and chlamydia reported in the United States in 2022.
Industry Prospects
Per a report by Grand View Research, the global STI testing market was valued at $10.1 billion in 2023 and is expected to witness a CAGR of 7.2% by 2030. The market is primarily influenced by advancements in diagnostic technology and increased government efforts to promote early detection and treatment.
Updates From Peers
Within the broader MedTech industry, several key players are involved in STI testing and diagnostics. These companies are also making other notable developments in their respective businesses.
Women’s health-focused company, Hologic (HOLX - Free Report) , dominates the U.S. markets for STI testing and is well-positioned to capture a larger share internationally. Last month, it acquired Endomagnetics Ltd (Endomag), the UK-based developer of breast cancer surgery technologies, in a transaction valued at approximately $310 million. The latter’s wireless breast surgery localization and lymphatic tracing solutions, including the Magseed marker, the Magtrace lymphatic tracer and the Sentimag platform, will complement and diversify Hologic’s expanding interventional breast health portfolio.
Renowned for its Sample to Insight solutions, QIAGEN (QGEN - Free Report) provides a range of STI tests through its Sexual & Reproductive Health portfolio, including tests for Chlamydia trachomatis and Neisseria gonorrhoeae infections. The company recently collaborated with the University of Montana to drive the implementation of next-generation sequencing and forensic investigative genetic genealogy in identifying human remains.
Furthermore, it introduced 35 new wet-lab-tested digital PCR Microbial DNA Detection Assays for the QIAcuity digital PCR platform. These assays target pathogens responsible for tropical diseases, STIs and urinary tract infections, further solidifying the company’s leadership in microbial detection and analysis.
Another peer, Thermo Fisher Scientific (TMO - Free Report) , offers several types of manual, automated or semi-automated in vitro diagnostic STI test kits and other STI testing products. The company’s SeCore CDx HLA A Sequencing System was recently granted the FDA 510(k) clearance as a companion diagnostic for Adaptimmune’s TECELRA (afamitresgene autoleucel) T-cell receptor therapy for unresectable or metastatic synovial sarcoma.
TMO also introduced a novel pre-transplant risk assessment (PTRA) assay that helps assess the risk of early acute rejection in kidney transplant recipients. The One Lambda PTR Assay is the first test of its kind, aiming to help inform clinical decision-making and support more personalized patient management, with the ultimate aim of improving outcomes.