ISNS International Society For Neonatal Screening

Membership

 

 

Our vision: ISNS is recognized worldwide for its contributions to the detection of neonatal conditions and the prevention of their adverse outcomes through excellence in neonatal screening.

Our mission:  To enhance the quality of testing and medical services through dissemination of information, guidelines and best practices that benefit all family members and their babies by helping to ensure protection of babies from life-quality threatening conditions.

 

Welcome !

Welcome to the website of the International Society for Neonatal Screening (ISNS).
This society is aiming to advance screening for neonatal and infant sicknesses and disorders, worldwide.
ISNS has around 350 members in more than 70 different countries. Most members have a professional (para)medical background but a few are involved in parents' or patients' organisations.

For more information about ISNS visit the ISNS-Info section (see above).

ISNS welcomes new members who have demonstrated an active interest in neonatal screening.

Why should I join as a member?

As a member you are entitled to see the privileged pages containing specific news items, a monthly neonatal screening literature service and a discount to ISNS-related conferences. Under certain conditions you may apply for travel grants to such conferences. Having access to the on line membership directory you have easier access to other members sharing specific interests.

How do I become a member?

Please read the Membership-info section (see above) and subsequently click on the button "Member subscribe"

 

Worldwide members per May 1, 2014

350 members in 68 countries.
Countries with at least one member are shown in blue-grey, others in green.

  • News
  • Events

FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency

December 15, 2014

The U.S. Food and Drug Administration today allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.

According to the Centers for Disease Control and Prevention, approximately 40 to100 new cases of SCID are identified in newborns in the United States each year. SCID is a group of disorders caused by defects in genes involved in the development and function of T cells and other infection-fighting immune cells. Babies with SCID appear normal at birth, but typically develop life-threatening infections within a few months. Without early intervention and treatment, death can occur within the baby’s first year; early detection and treatment can markedly improve survival. 

Using a few drops of blood taken from the newborn’s heel, which is dried on filter paper, the EnLite Neonatal TREC Kit can determine whether a certain type of DNA, known as T-cell receptor excision circles (TREC DNA), is low or missing from the newborn’s blood. Newborns with SCID typically have zero or low amounts of TREC DNA compared to healthy infants. Additional testing is required to obtain a SCID diagnosis. 

“SCID is a fatal disease that can be treated with early intervention, including screening,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “For the first time, the FDA is allowing the marketing of a newborn screening test that will enable states to incorporate an FDA reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,” added Gutierrez.

The Secretary of the U.S. Department of Health and Human Services and the Advisory Committee on Heritable Disorders in Newborns and Children recommend that every state screen newborn infants for SCID, among other genetic, endocrine and metabolic disorders. To date, 25 states plus the District of Columbia and the Navajo Nation have implemented screening programs for SCID. Some states have regulations requiring that their newborn screening program use an FDA-approved or FDA-cleared test.

The FDA reviewed the EnLite Neonatal TREC Kit through its de novo classification process, a regulatory pathway for some novel low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.  

The FDA’s review included a clinical study of approximately 6,400 blood spot specimens from routine screening of newborns, 17 of which had confirmed SCID diagnosis. The EnLite Neonatal TREC Kit correctly identified all 17 SCID cases. 

The agency also evaluated the test’s ability to accurately distinguish low TREC DNA numbers that would be observed in newborns with SCID, from high TREC DNA numbers that would be present in healthy newborns. The FDA found that the EnLite Neonatal TREC Kit could adequately detect very low TREC DNA values that are associated with SCID. 

The EnLite Neonatal TREC Kit is not intended for use as a diagnostic test or to screen for SCID-like syndromes, such as DiGeorge Syndrome or Omenn Syndrome. It is also not intended to screen for less acute SCID syndromes, such as leaky-SCID or variant SCID.

The EnLite Neonatal TREC Kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer, at its facility in Turku, Finland. PerkinElmer is based in Waltham, Massachusetts.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by 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.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426962.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

November 20th marked the 25th anniversary of the UN Convention of the Rights of the Child. Article 24 refers to the right for health care. This Convention has been ratified by all states (except Somalia, South Sudan and the Unites States). This means that the states promise to optimize health care for their infants and children. Newborn screening is an important public health programme that should be supported by the state.

For details on this Convention see http://www.ohchr.org/en/professionalinterest/pages/crc.aspx

Today at the APHL-NBSGT symposium the awards session was held. Two ISNS members were honoured.

Fred Lorey, ISNS Council member, received the George Cunningham Visionary Award. This award is given to honour a person working in U.S. newborn screening and judged by the Award Selection Committee to have made the greatest contribution to expanding or improving the screening of newborns by public health agencies in one or more states.

Julie Luedtke received the Judi Tuerck Newborn Screening Follow-up and Education Award. This award is given to honour a person working in newborn screening worldwide and judged by the Award Selection Committee to have made significant and outstanding contributions in  enhancing the caliber of the newborn screening system; improving follow-up and education; creative development or enhancement of short term follow-up strategies that significantly reduce days to diagnosis and treatment of affected infants.

ISNS is proud to have such distinguished colleagues in the membership and congratulates them both!