Photo by Dzenina Lukac on Pexels.com

FDA Approves Marketing of Woman’s Menopausal Status PicoAMH Test

PicoAMH Elisa Women Menopausal Status Test Cleared By FDA to Be Sold Commercially

(FDA Release)

Today, the U.S. Food and Drug Administration permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the determination of a patient’s menopausal status.

“Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms,” said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. “This test, when used in conjunction with other clinical assessments and laboratory findings, can help inform discussions about preventative care, such as ways to help prevent loss in bone mineral density or to address cardiovascular disease, both of which are known to increase after menopause.”

Menopause refers to the time in a woman’s life when she stops having a menstrual period and is no longer fertile. During the menopausal transition, the body’s production of estrogen and progesterone, two hormones made by the ovaries, varies greatly. Bones become less dense, making women more vulnerable to fractures. During this period, lipid profiles may change including increases in low density lipoprotein (LDL), a type of cholesterol. After menopause, women enter post-menopause, when they are more vulnerable to heart disease and osteoporosis. It is important for women to understand their stage of menopausal transition to learn what, if any, additional health risks they may face and any preventative health steps to take.

The PicoAMH Elisa test measures the amount of Anti-Müllerian Hormone (AMH) in the blood. AMH levels represent one indicator available to clinicians to determine whether a woman is approaching or is likely to have reached her final menstrual period. The PicoAMH Elisa test is meant to be used only in conjunction with other clinical assessments and laboratory findings.

The FDA reviewed data submitted by the sponsor that included 690 women, aged 42 to 62, who participated in the multi-center, longitudinal Study of Women’s Health Across the Nation . The data showed that the PicoAMH Elisa test performed reasonably well at determining levels of AMH in the blood and identifying women who had their last menstrual period and women who were more than five years away from their last menstrual period.

Clinicians should carefully evaluate PicoAMH Elisa test results in the context of a full clinical work up to ensure that contraceptives are not discontinued in women who have not yet reached menopause and that uterine bleeding due to endometrial cancer is not dismissed as a diagnosis. The PicoAMH Elisa test should not be used to assess a woman’s fertility status or to monitor or predict the ovarian response in women undergoing or planning to undergo fertility treatments.

The FDA reviewed data for the PicoAMH Elisa test through the de novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency’s expectations in assuring the accuracy, clinical performance and labeling of tests intended to be used as an aid in the determination of a patient’s menopausal status. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for these tests.

The FDA granted marketing authorization of the PicoAMH Elisa test to Ansh Labs.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

Check Also

Investor Image

SEC Announces March 28 Meeting of Investor Advisory Committee

Members of the committee represent a wide variety of investor interests, including those of individual and institutional investors, senior citizens, and state securities commissions. For a full list of committee members, see the committee’s webpage.

Where can I get business financing?

Horizon Technology Finance Provides Investment Portfolio Update Increases Portfolio Size with $24 Million in Loan Originations; Grows Committed Backlog to $47 Million

"During the third quarter, we experienced solid investment activity, increasing the size of our portfolio and expanding our committed backlog for the second consecutive quarter," said Gerald A. Michaud, President of Horizon. "Our success funding seven loans, totaling more than $24 million, and growing our committed backlog to $47 million underscores the strong demand for our venture debt products to growing life science and technology companies. We believe Horizon will continue to benefit from a robust pipeline of investment opportunities and is well positioned to deliver long-term, disciplined portfolio growth, while ensuring credit quality remains strong."

Doctor is warning against side effects of medicine

FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (Febuxostat)

Uloric was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S.1 The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.

ECB profit increased in 2018

Financial Statements of the ECB for 2018

The ECB’s net profit is distributed to the euro area national central banks (NCBs). The Governing Council decided to make an interim profit distribution, amounting to €1,191 million, to the euro area NCBs on 31 January 2019. At yesterday’s meeting, the Governing Council decided to distribute the remainder of the profit, amounting to €384 million, on 22 February 2019.

Litigation Photo

Immune Design (IMDZ) Alert: Johnson Fistel Investigates Proposed Sale of Immune Design Corp.; Are Immune Design Shareholders Getting a Fair Deal?

The investigation concerns whether the Immune Design board failed to satisfy its duties to the Company shareholders, including whether the board adequately pursued alternatives to the acquisition and whether the board obtained the best price possible for Immune Design shares of common stock. Nationally recognized Johnson Fistel is investigating whether the proposed deal represents adequate consideration, especially given that one Wall Street analyst has a $9.00 price target on the stock and the Company has approximately $100 million in cash and no long-term debt.

Mergers and Acquisitions

Merck to Acquire Immune Design; Acquisition Bolsters Capabilities in Vaccine Development for Infectious Diseases and Cancer

“Scientists at Immune Design have established a unique portfolio of approaches to cancer immunization and adjuvant systems designed to enhance the ability of a vaccine to protect against infection, which could meaningfully improve vaccine development," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This acquisition builds upon Merck’s industry-leading programs that harness the power of the immune system to prevent and treat disease.”

SEC Files Charges in Elaborate Microcap Stock Fraud

“As alleged in our complaint, Magna Group and its co-defendants used fake debt instruments to unlawfully obtain shares in microcap companies, which they then dumped on unsuspecting retail investors,” said Sanjay Wadhwa, Senior Associate Director of the SEC’s New York Regional Office. “This action demonstrates the resolve of the SEC in pursuing fraudsters who use elaborate financing schemes to engage in securities fraud.”

%d bloggers like this: