Testing options for the range of health issues women face has grown exponentially in recent years. This collection of products runs the gamut from prenatal testing to oncology tests. An abridged version of the showcase appears in CLP‘s February 2013 print issue. (Listed alphabetically by company.)
See our recent article on women’s health, titled “Conquering Cervical Cancer.”
Ovarian Cancer Monitoring Test
HE4 assay uses a simple blood test
The ARCHITECT HE4 assay from Abbott Diagnostics, Abbott Park, Ill, helps monitor the recurrence or 
progression of ovarian cancer. The HE4 (human epididymis protein 4) assay uses a simple blood test to aid in monitoring for the recurrence or progression of this disease. The current test most widely used to monitor ovarian cancer, CA125, measures levels of a protein in the blood as an indication of a possible recurrence of disease progression in ovarian cancer patients. While 80% of ovarian cancers express CA125, 20% of all ovarian cancers do not. By using this test in conjunction with other clinical methods, including CA125, physicians can get a more comprehensive clinical picture when monitoring ovarian cancer patients.
Abbott Diagnostics
(847) 937-7235; www.abbottdiagnostics.com
New Testosterone Test to Measure the Hormone at Low Levels
Helps diagnose related conditions in women
The ARCHITECT 2nd Generation Testosterone assay from Abbott Diagnostics, Abbott Park, Ill, which runs on Abbott’s fully automated ARCHITECT family of analyzers (model i2000SR pictured), helps 
physicians accurately measure the wide range of testosterone levels seen in both women and men. It is a chemiluminescent microparticle immunoassay for the quantitative determination of testosterone in human serum and plasma. Measurement of testosterone plays an important part in the diagnosis of many conditions, and it can guide treatment decisions. Levels are associated with sexual development, libido, protection against osteoporosis, and cardiovascular health. Polycystic ovary syndrome (PCOS) is a common endocrine disorder that can result in excessive production of testosterone, leading to infertility, irregular or absent menstrual periods, and hirsutism (excess body and facial hair). Inappropriate testosterone levels can also result in precocious or delayed puberty.
Abbott Diagnostics
(847) 937-7235; www.abbottdiagnostics.com
Comprehensive breast tumor profiling
Comprised of four assays
Agendia, Irvine, Calif, offers Symphony, which consists of four assays that support physicians’ treatment decisions with comprehensive genomic profiles. MammaPrint is a prognostic test designed to help determine the risk of recurrence; BluePrint identifies molecular subtypes to help in physicians select therapies with the best clinical outcomes; TargetPrint uses mRNA to confirm receptor status for ER, PR, and HER2 to help guide hormonal therapy; and TheraPrint provides gene expression for 56 genes that have published correlations to therapy response in metastatic disease.
Agendia
(888) 321-2732; www.agendia.com
MDx Prenatal Test
Accuracy of detection greater than 99% for trisomy 21
The Harmony test from Ariosa Diagnostics, San Jose, Calif, offers an early, accurate, and personalized 
option for determining a pregnant woman’s risk of carrying a fetus with common genetic conditions. The noninvasive test analyzes cfDNA circulating in maternal blood. It is performed once during pregnancy, as early as 10 weeks’ gestation. Combined with a statistical algorithm that factors maternal age, gestational age, and the percentage of fetal DNA in the sample, the test provides a personalized fetal risk assessment for trisomies that cause Down, Edwards, and Patau syndromes. Accuracy of detection is greater than 99% for trisomy 21, which causes Down syndrome. The false-positive rate is less than 0.1%.
Ariosa Diagnostics
(855) 927-4672; www.ariosadx.com
Fertility Assessment
Complete assessment panel
With many possible causes of infertility, such as premature ovarian failure, polycystic ovarian syndrome, 
endometriosis, hyperprolactinemia, and male factor infertility, diagnosis of infertility can be complex. Beckman Coulter, Brea, Calif, offers a complete assessment panel that includes DHEA-S, Estradiol, hFSH, hLH, progesterone, prolactin, sex hormone binding globulin (SHBG), and testosterone. These tests can aid in the diagnosis of the underlying cause of infertility and its management. The company also offers a comprehensive panel for monitoring reproductive health during pregnancy. The tests can be performed on the company’s Access 2 immunoassay system (pictured, right) and on its UniCel DxI 600 immunoassay system (pictured, below).
Beckman Coulter
(800) 352-3433; www.beckmancoulter.com
Reproductive Aging
Assays for assessment of menopause and andropause
Reflected by diminishing hormone levels, endocrine function in both men and women declines with age. Physicians look to the lab for assessment of this drop in hormone levels and the subsequent need for management. Menopause is the transitional phase in a woman’s life when the ovaries stop releasing eggs and subsequently, production of estrogen and other hormones declines. Beckman Coulter, Brea, Calif, offers assays for assessment of ovarian function, including estradiol, hLH and hFSH. The assays can be performed on the company’s Access 2 immunoassay system (pictured, above) and on its UniCel DxI 600 immunoassay system (pictured, right).
Beckman Coulter
(800) 352-3433; www.beckmancoulter.com
CT/NG Test
Categorized Moderate Complexity by FDA
The FDA has recently categorized the Xpert® CT/NG test from Cepheid, Sunnyvale, Calif, as “Moderate 
Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The test runs on the company’s GeneXpert® Systems. The categorization will now allow the accuracy benefits of molecular diagnostics to be realized over a broader testing universe, the company says.
Cepheid
(408) 541-4191; www.cepheid.com
Cervical Cancer Screening
Components for comprehensive cervical cancer testing
The ThinPrep® Imaging System, from Hologic Inc, Bedford, Mass, represents a significant advance in diagnostic capability, with two unique components for comprehensive and accurate cervical cancer testing. The ThinPrep Pap Test offers several advantages over the conventional Pap smear, including improved disease detection and testing for HPV, chlamydia, and gonorrhea straight from the vial. The ThinPrep Imaging System with Dual Review offers additional advantages over manually reviewed ThinPrep Pap Test slides.
Hologic Inc
(781) 999-7300; www.hologicworldwide.com
HSV 1&2 Kit
PCR-based
The MultiCode®-RTx HSV 1&2 Kit from Luminex, Austin, Tex, is a real-time polymerase chain reaction (PCR)-based, qualitative in vitro diagnostic test. It can perform detection and typing of the herpes simplex virus (HSV1&2) in a single reaction. MultiCode technology is based on the patented synthetic base pair, isoC and isoG, which eliminate the need for a probe. The probe-free chemistry offers greater flexibility, specificity, and sensitivity. Reproducibility has been shown at 99.7%. In addition, there is no need for any capital equipment purchase, as the chemistry can be used on commonly available instrumentation for extraction and amplification. The streamlined workflow and automated analysis software simplifies implementation, and provides same-day results for rapid turnaround time.
Luminex
(888) 219-8020; www.luminexcorp.com
First Trimester Screen
Noninvasive prenatal test
NTD Labs, Melville, NY, from PerkinElmer, offers First Trimester Screen | Fß, the lab’s first-trimester prenatal screening test for Down syndrome. The test features a noninvasive method to determine a 
patient’s risk for having a baby with Down syndrome, and trisomy 18 and 13 earlier in the pregnancy than some alternative protocols and with higher detection rates and lower false positive rates. The test is a high-sensitivity prenatal screen that uses the free beta hCG biomarker along with PAPP-A and Nuchal Translucency measurement in assessing individual patient risk for a fetus with Down syndrome. With the use of this screen, physicians can provide earlier assurance and earlier answers at a 91% detection rate and a 5% false positive rate for Down syndrome (sensitivity increases to a 95% detection rate at a 2% false positive rate for Down syndrome when patients undergo a prenatal fetal nasal bone assessment as well).
NTD Labs
(888) 683-5227; www.ntdlabs.com
Urine Dipstick Controls
Easy-to-use liquid controls
Dipper Urine Dipstick Control, Dropper Urine Dipstick Control, Dropper Plus POC Urine Dipstick Control, 
and Dip & Spin Urine Dipstick/Microscopics Control by Quantimetrix, Redondo Beach, Calif, have several applications for women’s health diagnostics. These easy-to-use liquid controls are available in two-level sets. The level 1 UDC controls are negative for hCG, while the level 2 UDC controls are hCG positive using qualitative hCG test kits. In combination, these Level 1 and 2 UDC controls can be used to confirm the performance of these test kits for the assessment of pregnancy status. The Level 1 Control is negative and the Level 2 control is positive for nitrites and leukocytes. These results are used to screen for possible urinary tract infections, which are much more common in women than in men. Included with these products are values for all dipstick analytes plus microalbumin and creatinine—and qualitative results for hCG early pregnancy detection test methods. Quantimetrix UDC products are designed for use with most reagent strips (refer to lot-specific insert for included manufacturers). They can also be used for confirmatory tests and refractometry.
Quantimetrix
(800) 624-8380; www.4qc.com
Molecular Test Helps Evaluate Risk of Cervical Cancer
IDs molecular changes to cervical cells
Quest Diagnostics, Madison, NJ, offers the Cervical Cancer TERC lab-developed test, a lab test that 
identifies molecular changes to cervical cells that increase the likelihood a woman may develop cervical cancer. The test is available to help physicians identify women who are at increased risk of developing malignancy, unless treated, after receiving unclear results for cervical cancer risk from standard screening tests. It is designed as an adjunct to conventional Pap and HPV tests, and is performed on residual samples from Pap tests. It detects abnormal changes to the TERC gene and chromosome 3 to provide information to enable a physician to assess the risk of progression to cervical cancer in women who receive indeterminate Pap and/or HPV test results. TERC results can help physicians categorize risk (removed PAP because of concerns people will think it is part of PAP testing) prior to colposcopy. It may be particularly helpful in evaluating women whose Pap test shows mild cellular abnormalities known as low-grade squamous intraepithelial lesions (LSIL).
Quest Diagnostics
(800) 222-0446; www.questdiagnostics.com
One-Step hCG Combo test
Highly sensitive assay with built-in controls
The QuickVue+ One-Step hCG Combo test from Quidel Corp, San Diego, is a sensitive immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology to accurately detect hCG. Results are available in 5 minutes (serum) and 3 minutes (urine); positive results may become visible sooner. The test features >99% sensitivity, specificity, and accuracy; 10 mIU/mL sensitivity in serum or 20 mIU/mL sensitivity in urine. It can be stored at room temperature and has a 21-month shelf life. The simple, one-step procedure uses only four drops of sample. The test offers lot-to-lot consistency.
Quidel Corp
(800) 874-1517; www.quidel.com
One-Step hCG Combo and Urine tests
Two-color end point for easy-to-read and interpret results
The QuickVue One-Step hCG Combo and Urine tests from Quidel Corp, San Diego, are sensitive immunoassays for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. Results are available in 5 minutes (serum), 3 minutes (urine); positive may become visible sooner. The test features >99% sensitivity, specificity, and accuracy; 25 mIU/mL sensitivity in serum or urine. It can be stored at room temperature, and it has an 18-month shelf life. The simple, one-step procedure uses only three drops of sample, and a two-color end point ensures easy-to-read and interpret results. The highly sensitive assay with built-in controls offers lot-to-lot consistency
Quidel Corp
(800) 874-1517; www.quidel.com
Chlamydia Test
Patients can be tested, treated in the same office visit
The QuickVue Chlamydia test from Quidel Corp, San Diego, provides fast and accurate results, all in one 
office visit, and offers high sensitivity and specificity in all patient populations. The test is easy to perform and interpret from an endocervical swab or cytology brush specimen. All components necessary to perform the test are contained in the kit, including swabs. Results are available in 12 minutes or less. The test features a self-contained test cassette, and the simple extraction procedure requires just two reagents. After extraction, add the sample to the test cassette and the two-color endpoint provides easy to read and interpret results. Sensitivity 92%; specificity 99% (overall); highly accurate in asymptomatic patient population: 94% sensitivity, 99% specificity. Room-temperature storage (9 months from date of manufacture). Built-in positive and negative controls confirm the test has performed properly; positive and negative external controls are provided in the kit.
Quidel Corp
(800) 874-1517; www.quidel.com
Fully automated PCR testing
For HPV and CT/NG
The PCR-based cobas 4800 system from Roche Diagnostics Corp, Indianapolis, offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests to meet the needs of the majority of clinical labs. The menu currently includes FDA-approved tests for chlamydia/gonorrhea (CT/NG), BRAF, and HPV (a 3-in-1 test that simultaneously provides a pooled result for 12 high-risk genotypes and individual results for the highest-risk genotypes, HPV 16 and 18).
Roche Diagnostics Corp
(800) 428-5076; www.mylabonline.com
CLIA-Waived Rapid Test
Aids in the diagnosis of bacterial vaginosis
OSOM BVBLUE from Sekisui Diagnostics LLC, San Diego, is a CLIA-waived rapid test that aids in the diagnosis of bacterial vaginosis. More sensitive than wet mount, the test detects elevated activity of vaginal fluid sialidase, an enzyme produced by bacterial pathogens including Gardnerella, Mobiluncus, Bacteroides, and Prevotella. With less than 1 minute hands-on time, this test provides clear, objective results in 10 minutes. The solution turns blue or green if positive, yellow if negative. It is 92.8% sensitive and 98% specific versus gram stain, the gold standard. Studies have shown that bacterial vaginosis may increase the risk of preterm delivery, low-birth-weight infants, endometritis, pelvic inflammatory disease, and miscarriage, and it increases the susceptibility to HIV and other STDs.
Sekisui Diagnostics LLC
(800) 332-1042; www.sekisuidiagnostics.com
Trichomonas Rapid Test
Antigen-based
The OSOM Trichomonas Rapid Test from Sekisui Diagnostics LLC, San Diego, is a CLIA-waived rapid test for the detection of Trichomonas vaginalis. With less than 1 minute hands-on time, this test provides easy-to-read, sensitive, objective results in 10 minutes or less. Antigen-based, the test does not require organism motility in order to be accurate. The test provides accurate results with a sensitivity of 83% versus culture and wet mount combined, and is included in the ACOG and Centers for Disease Control and Prevention guidelines.
Sekisui Diagnostics LLC
(800) 332-1042; www.sekisuidiagnostics.com
Noninvasive Maternal Blood Test
Laboratory-developed test
The MaterniT21 PLUS laboratory-developed test (LDT) from Sequenom, San Diego, analyzes the relative amount of chromosomal 21, 18, and 13 material in circulating cell-free DNA for fetal trisomies. The 
noninvasive maternal blood test is indicated for use in pregnant women at increased risk for fetal aneuploidy and can be used as early as 10 weeks’ gestation. Estimates suggest there are about 750,000 pregnancies at high risk for fetal aneuploidy each year in the United States. The American College of Obstetricians and Gynecologists Committee on Genetics and the Society for Maternal-Fetal Medicine Publications Committee supports noninvasive prenatal testing for fetal aneuploidy in high-risk women. The test is available exclusively through the Sequenom Center for Molecular Medicine as a testing service provided to physicians.
Sequenom
(858) 202-9000; www.Sequenomcmm.com
Serum HER-2/neu test
For quantitative determination in human serum
The Serum HER-2/neu test from Siemens Healthcare Diagnostics, Tarrytown, NY, is a simple blood test 
for the quantitative determination of the HER-2/neu protein in human serum using the automated ADVIA Centaur® XP/CP system. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. Monitoring Serum HER-2/neu levels yields important information about response to therapy and cancer progression, and may help physicians make more informed decisions when developing and modifying patient treatment regimens. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established.
Siemens Healthcare Diagnostics
(888) 588-3916; www.usa.siemens.com/diagnostics
Androstenedione assay
Quantitative measurement in human serum
The IMMULITE® androstenedione assay from Siemens Healthcare Diagnostics, Tarrytown, NY, is an IVD immunoassay for the quantitative measurement of androstenedione in human serum using the IMMULITE 1000 or IMMULITE 2000 XPi systems. Androstenedione is a steroid that serves as a major precursor for testosterone and estrone. It is often elevated in cases of abnormal hair growth (hirsutism), virilization, and in patients with polycystic ovarian syndrome. Androstenedione exhibits a diurnal variation, being highest in the morning, and also a cyclical variation during the menstrual cycle, being highest near midcycle. During
pregnancy, there is an increase in the plasma level.
Siemens Healthcare Diagnostics
(888) 588-3916; www.usa.siemens.com/diagnostics
Anti-CCP Assay
Aids in diagnosis of rheumatoid arthritis
The IMMULITE anti-CCP assay from Siemens Healthcare Diagnostics, Tarrytown, NY, is a highly specific immunoassay used as an aid in the diagnosis of rheumatoid arthritis (RA) through the semiquantitative measurement of human IgG to cyclic citrullinated peptide (CCP) in serum and plasma. Timely RA diagnosis is critical in order to treat patients as early as possible, thereby delaying and/or preventing joint destruction and deformity. Anti-CCP antibodies are detectable very early in the disease and are also reported to predict the development of erosive RA. The assay offers excellent specificity for RA diagnosis and differentiation from other diseases. It is fully automated, enabling labs to incorporate anti-CCP testing into their routine workflow. Under FDA review. Not available for sale in the United States. Product availability varies by country.
Siemens Healthcare Diagnostics
(888) 588-3916; www.usa.siemens.com/diagnostics
Estrogen Receptor (ER) (SP1) IHC Assay
Aids in management and prediction of hormone therapy for breast carcinoma
CONFIRM Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody from Ventana Medical Systems, Inc, Tucson, Ariz, (a member of the Roche Group) delivers precise determination of ER expression status to ensure eligible patients are identified for hormone therapy. This antibody demonstrates superior sensitivity and specificity in breast carcinoma samples compared to mouse monoclonal antibodies, and allows for fast, accurate results with complete automation and a ready-to-use reagent format.
Ventana Medical Systems, Inc
(800) 227-2155; www.ventana.com
Breast Cancer Diagnostic Solutions
Enable oncologists and patients with fast, accurate answers
Ventana Medical Systems, Inc, Tucson, Ariz, empowers labs with a comprehensive suite of immunohistochemistry (IHC) and in situ hybridization (ISH) diagnostic assays for breast cancer. The company offers breast cancer predictive diagnostic offerings such as HER2 IHC and ISH, ER, PR; supporting assays—Ki-67, p120, and E-cadherin; assays that are fully automated on VENTANA BenchMark IHC/ISH staining platforms that reduce time to result and resources required compared to manual or semiautomated solutions.
Ventana Medical Systems, Inc
(800) 227-2155; www.ventana.com
p16 Histology biomarker
For clinical evaluation of cervical biopsies
Ventana Medical Systems, Inc, Tucson, Ariz, offers the CINtec® p16 Histology biomarker, with results that reveal more information than H&E alone. The overexpression of p16 in precancerous and cancerous tissues is highly correlated with the oncogenic transformation linked to persistent high-risk HPV infections. This biomarker is available in a ready-to-use dispenser, fully automated on VENTANA BenchMark XT and BenchMark ULTRA instruments using OptiView DAB IHC or ultraView DAB detection.
Ventana Medical Systems, Inc
(800) 227-2155; www.ventana.com
Noninvasive Prenatal Test
For high-risk pregnancies
The Verinata verifi® test from Verinata Health Inc, Redwood City, Calif, is a broad noninvasive prenatal
test (NIPT) for high-risk pregnancies. It analyzes cell-free fetal DNA naturally found in a pregnant woman’s blood to look for missing or extra copies of chromosomes (referred to as aneuploidies). Specifically, the 
test detects Down syndrome (trisomy 21 or T21), Edwards syndrome (trisomy 18 or T18), and Patau syndrome (trisomy 13 or T13). It offers the option to include evaluation of sex chromosome aneuploidies, such as Turner syndrome (Monosomy X), Triple X (XXX), Klinefelter syndrome (XXY), and Jacobs syndrome (XYY)—the most common fetal sex chromosome abnormalities. The verifi test with the sex chromosome option may aid in stratifying the risk for X-linked disorders such as hemophilia and Duchenne muscular dystrophy, and in evaluating cases of ambiguous genitalia such as congenital adrenal hyperplasia.
Verinata Health Inc
(650) 503-5200; www.verinata.com
