Women’s Health Care
A primary focus of Genetic Assays (GA) since its inception in 1994 has been to provide the latest, cutting-edge molecular testing available. These tests have made the most dramatic impact on the detection and diagnosis of diseases in women. GA provides women’s health care specialists with the most advanced molecular testing to detect infections, cancer-causing viruses and inherited diseases. GA is determined to meet/exceed the standards of women’s health care recommended by the nation’s leading authorities, such as the American Congress of Obstetricians and Gynecologists (ACOG), American Society for Colposcopy and Cervical Pathology (ASCCP), and Centers for Disease Control and Prevention (CDC).
The human papilloma virus (HPV) is one of the most common sexually transmitted diseases. Low-risk types cause genital warts and high-risk types can lead to cervical cancer. Most infections are resolved by the body's natural immune defenses. However, persistent infection with high-risk HPV can lead to cervical cancer. GA performs the Qiagen Hybrid Capture II HPV DNA test, which has a proven sensitivity of 100% when combined with a Pap for detection of CIN2/3+. ACOG and ASCCP recommend co-testing using the combination of cytology plus HPV DNA testing as an appropriate screening test for women 30 years and older.
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With PCR and DNA Sequencing, GA is able to determine the specific subtype of HPV present in a patient sample (i.e. type 6, 16, 51, etc.). According to the ASCCP, for cytology negative women 30 years and older who test positive for high-risk HPV DNA, molecular genotyping assays that identify HPV 16 and 18 are clinically useful for differentiating which women should be referred for immediate colposcopy, and which should be followed-up with repeat cytology and high-risk HPV testing in 12 months.
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CDC and ACOG recommend annual CT/NG screening of:
- All sexually active women aged 25 years and younger
- Older women with risk factors (e.g. those with a new sex partner or multiple sex partners)
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HSV DNA by PCR is the most specific, rapid, and sensitive means to detect and differentiate HSV types 1 and 2. Infants exposed to HSV during vaginal delivery are at a high risk of developing neonatal herpes.
Cystic Fibrosis is the most common fatal genetic disease in the United States and affects about 1 in 2,500 live births. It is a recessive disorder and requires that a mutation be inherited from both parents. The mutation is most common in Caucasian Americans with approximately 1 in 29 being carriers. ACOG recommends DNA screening for Cystic Fibrosis be made available to all couples seeking preconception or prenatal care – not just those with a personal/family history of carrying the CF gene.
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Bacteria vaginosis is an infection caused when too much of certain bacteria change the normal balance of bacteria in the vagina. It is the most common vaginal infection in women ages 15-44. Having bacterial vaginosis can increase the chance of getting an STD.
This assay uses real-time PCR for the simultaneous and multiplex amplification and detection of the DNA of the following causative pathogens of bacterial vaginosis: Candida species (C. albicans, C. glabrata, C. kefyr, C. krusei, C. parapsilosis, C. tropicalis), Candida albicans, Gardnerella vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Trichomonas vaginalis, and Ureaplasma urealyticum.

Trichomonas vaginalis (TV) is a protozoan parasite and an etiological agent for trichomoniasis, a sexually transmitted infection (STI). It is the most prevalent STI and often goes untreated because a significant percentage (>50%) of men and women are asymptomatic. TV infections left untreated can cause cervicitis, vaginitis, pelvic inflammatory disease, pre-term delivery, urethritis and infertility. Infected individuals are at a higher risk of contracting other STIs, especially HIV. The prevalence of TV increases with age and is most common in women ages 35-45.