Emerging Biomarkers for Reproductive Health offered by Ansh Labs

Most biomarkers start out with a specific application; however, as more researchers become involved, the range of applicable areas increases significantly. Initially, Anti-Mullerian Hormone (AMH) was used in determining neonatal gender in cases of ambiguous genitalia. Not long after, AMH became very popular in estimating ovarian reserve. In recent years, the level of interest in measuring AMH in PCOS patients has increased substantially. From the first publication about PCOS in December 2003, the number of AMH with PCOS and menopause studies has increased substantially and will likely exceed the number of ovarian reserve publications.

reprohealthchart_full

Ansh Labs’ current feature products include novel immunoassay test kits for reproductive function such as anti-Müllerian hormone (AMH), Inhibin B, Inhibin A, Activin A, Follistatin, and other TGF-beta superfamily hormones involved in folliculogenesis [EduGraphic]. There are many ongoing studies of these hormones using our assays and rapidly growing interest in new diagnostic applications in gynecology and oncology. Our most recent additions to this assay family were Follistatin Like-3 and Activin B, along with GDF-9 and BMP-15 in development.

Following, we have put together a list of recommended readings that discusses in-depth the various assays and their role in the various disease states.

Jump to section on:
     Menopause
     Premature Ovarian Failure (POF)
     Polycystic Ovary Syndrome
     Cancers of the Reproductive System
     Oncofertility
     Male Infertility
     Assisted Reproductive Technology
     Disorders of Sex Development
     Species-Specific Assays and Crossreactivity

 Menopause

Traditionally FSH is measured to diagnose menopause. FSH, secreted from the anterior pituitary gland offers an indirect measure of ovarian reserve and is subject to cycle variability. Hormones produced from the ovary serve as direct markers of ovarian reserve. AMH and Inhibin B levels have been shown to decline approaching menopause and numerous studies report correlation of AMH decline with onset of menopause complications. With the introduction of our picoAMH ELISA, researchers now have a sensitive AMH assay for the staging of ovarian age and prediction of the onset of menopause. Accurate prediction of the final menstrual period will be tremendously advantageous for physicians to decide a proper hormone replacement therapy to ameliorate vasomotor symptoms, decide appropriateness of cessation of contraception, make recommendations for bone mineral density (BMD) measurement early on to identify patients at high risk of losing bone at an accelerated rate leading to osteoporosis, identify those early menopause onset women with increased risk of breast cancer and cardiovascular or stroke event risk, etc.

Related Products from Ansh Labs: AMH, Inhibin A, Inhibin B

Recommended Reading

Conference Posters

 Premature Ovarian Failure (POF)

POF is defined as loss of function of ovaries before age 40. Underlying causes range from chromosomal defects to chemotherapy induced gonadal toxicity. AMH and Inhibins applicable to menopause diagnosis may also be useful in the diagnosis of POF leading to early onset menopause. Numerous studies associate mutations in BMP-15 and GDF-9 with POF, though it is yet to be determined if follicular fluid concentrations of these proteins is useful in assessment of POF.

Related Products from Ansh Labs: AMH, Inhibin A, Inhibin B, Total Inhibin, BMP-15 (coming soon), GDF-9 (coming soon)

Recommended Reading

 Polycystic Ovary Syndrome (PCOS)

PCOS is a complex endocrine system disorder with reproductive, metabolic, cardiovascular and psychological manifestations. Our objectives include establishing the utility of AMH and other novel ovarian health markers for research and clinical applications in PCOS, menopause, etc. We believe that the underdiagnosis of PCOS is a significant medical problem. Menstrual history and ultrasonography along with serum-based markers like testosterone and LH to FSH ratio are currently used to diagnose PCOS. However, these methods are error-prone and are at best suggestive of PCOS. AMH levels are reported high in PCOS patients and in recent years has gained considerable attention as a potential diagnostic tool. There is a tremendous need to address these limitations to improve patient quality of life from menarche through menopause by encouraging the early diagnosis of PCOS with effective assays and diagnostic standards. It is for this reason that Ansh Labs is actively working in close collaboration with many known opinion leaders to better understand this biomarker and its potential role in PCOS.

Related Products from Ansh Labs: AMH, , Dried Blood Spot AMHInhibin A, Inhibin B, Total Inhibin, FST, FSTL-3, BMP-15 (coming soon), GDF-9 (coming soon)

Recommended Reading

Conference Posters

  Cancers of Reproductive System

Besides their utility in assessment of ovarian reserve, many TGF-beta superfamily proteins may also be useful in researching various cancers of the reproductive system. Two independent studies using Ansh Labs’ AMH assays reported a positive correlation between AMH and breast cancer risk in premenopausal women. AMH was also reported as a biomarker for adult-type granulosa cell tumors. Utility of AMH as a biomarker in cancer research is further supported by animal studies where serum AMH levels were used to diagnose canine Sertoli cell tumors and granulosa cell tumors in mares. Additionally, several studies highlight the importance of Inhibin A, Inhibin B, Follistatin and Follistatin-Like 3 as biomarkers in cancers such as granulosa cell tumors, breast cancer, and ovarian cancer.

Related Products from Ansh Labs: AMHDried Blood Spot AMHInhibin A, Inhibin B, Total Inhibin, FST, FSTL-3

Recommended Reading

  Oncofertility

Several cancers and the treatment regimens adversely affect gonadal health, thus preserving the reproductive future is a major emotional and financial concern among cancer survivors. Numerous studies show the promise of AMH as a serum-based biomarker for the assessment of ovarian reserve in cancer patients and survivors. It is important to note that assessment of ovarian reserve in certain cancer patients and survivors involves measuring very low AMH levels. Several studies comparing AMH immunoassays show that Ansh Labs’ highly sensitive AMH assays accurately measure AMH levels reported as undetected by other commercial assays.

Ansh Labs has also developed an AMH assay that uses dry blood spots compared to the conventional serum or plasma samples. Dried blood spot specimens stability makes it a practical alternative to venous blood. It opens new possibilities in AMH testing, such as comparison of historical to current patient results; simplified blood sampling for patients in remote locations or for those who are homebound.

Related Products from Ansh Labs: AMH, Dried Blood Spot AMH

Recommended Reading

  Male Infertility

Inhibins and Activins are gonadal hormones relevant for the assessment of testicular function. Serum Inhibin B and Activin A levels have been correlated with several conditions affecting spermatogenesis and patients with idiopathic male infertility show higher levels of Activin A in serum and semen samples as compared to fertile donors. Serum Inhibin B was also found to be useful in the prediction of azoospermia risk in testicular cancer patients post-treatment. Ansh Labs has developed a panel of highly specific Inhibin B and Activin assays. These assays enabled us to determine that Activin A is predominant over Activin B and Inhibin complexes in azoospermia patients (poster available at: http://www.anshlabs.com/overview-activins-and-inhibins/).

Related Products from Ansh Labs: Inhibin and Activin assays

Recommended Reading

  Assisted Reproductive Technology

Prognostic role of AMH in assisted reproductive is well studied. Numerous studies focusing on patients undergoing in vitro fertility and intracytoplasmic sperm injection (IVF/ICSI) report correlation between AMH and treatment outcomes. Seminal AMH levels were reported to be useful in predicting motile sperm recovery rate in cryopreserved semen from asthenozoospermic men. Seminal AMH may also be useful in selecting infertile patients for recombinant FSH treatment.

Though major focus has been on AMH, studies also show that serum Activin A can be a marker of outcomes in pregnancies conceived via IVF. Levels of Inhibin B in follicular fluid correlates with presence of oocyte and Activin A/Inhibin B ratio in follicular fluid has also been shown to correlate with the number of oocytes retrieved. Inhibin B levels were reported to gradually increase during controlled ovarian hyperstimulation procedure and correlated with outcomes.

Related Products from Ansh Labs: AMH, Inhibin and Activin assays

Recommended Reading

  Disorders of Sex Development

During embryonic development, AMH plays an important role in sexual differentiation. In the male fetus the expression of AMH from primitive Sertoli cells causes Mullerian duct regression, while in the female fetus the absence of AMH allows for development of female reproductive organs. AMH levels at birth are very high in boys and very low to undetectable in girls. In cases of ambiguous genitalia, AMH measurement becomes essential to determine the presence of testicular tissue. Many other conditions involving disorders of sex development rely on AMH assessment for determining treatment options. Ansh Labs’ picoAMH, Dried Blood Spot AMH, and Inhibin B assays are particularly well suited for AMH measurement in pediatric populations with low AMH levels and sample volume limitations.

Related Products from Ansh Labs: AMH, Dried Blood Spot AMHInhibin B

Recommended Reading

 

animalSpecies Specific Assays and Cross-reactivity

In addition to client publications and reports, Ansh Labs has also validated many of its immunoassays for various animal species as well as offering an array of species-specific assays.  For more information, please reference our Species Specific Immunoassays summary.

Date Published:  March 9, 2017