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Premaitha Health’s Iona Test Becomes First CE-Marked Diagnostic for NIPT
Premaitha Health has received the CE mark for the Iona test, making the Iona the first in vitro diagnostic for non-invasive prenatal testing (NIPT) to meet the quality standards set down by Europe’s In Vitro Diagnostic Medical Device Directive. The Iona test uses next-generation sequencing technology to estimate the risk of a fetus having trisomies 21, 18, and 13 by analyzing cell-free fetal DNA from a sample of maternal blood. It provides a complete system to clinical laboratories that includes DNA extraction through to data analysis with a standardized workflow.
Presently, pregnant women in Europe and the U.K. can only access NIPT via the private testing market provided by service laboratories. According to Premaitha Health, this means that their blood samples are sent to labs in the U.S. or China, which can lead to a wait time for results of up to 2 weeks. Now that the European regulatory agencies have authorized the Iona test, hospitals across Europe and the U.K. will have the option of providing pregnant women with a local non-invasive prenatal test with a turnaround time of 3 days.
Premaitha Health believes this could speed the dissemination of NIPT throughout Europe, potentially reducing
the number of women who undergo unnecessary confirmatory invasive prenatal testing due to false-positive results from current prenatal screens.
Bloom Syndrome Test Becomes First 23andMe Test to Receive FDA Clearance
The Food and Drug Administration (FDA) has granted 23andMe 510(k) clearance for its Bloom syndrome carrier test, a direct-to-consumer (DTC) genetic test that determines whether healthy individuals have a genetic variant that could lead to their children inheriting this disorder. This marks a major milestone for 23andMe after FDA ordered the company in 2013 to stop selling its DTC genetic testing service.
Just as it has for other home-use medical tests, such as those for pregnancy and HIV, FDA will require the Bloom syndrome test’s results to be conveyed in a way that consumers can understand and use. To address concerns that DTC genetic test results may mislead consumers, the agency is also requiring that 23andMe explain in the test’s labeling what the results might mean for prospective parents interested in seeing if they are Bloom syndrome carriers. Additionally, if 23andMe sells this test over the counter, it must include information about how consumers can access a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling.
Along with this clearance, FDA has also decided to classify carrier screening tests as class II and has stated that it eventually aims to exempt these tests from premarket review.
Given the probability of erroneous results, professional societies typically recommend that only prospective parents with a family history of a genetic disorder undergo carrier screening.
WHO Authorizes Use of First Rapid Test for Ebola
The World Health Organization (WHO) has assessed and listed Corgenix’s ReEBOV Antigen Rapid Test Kit as eligible for use in Ebola-affected countries. The test was evaluated under WHO’s Emergency Assessment and Use, a procedure established to provide minimum quality, safety, and performance assurance for diagnostic products used in the current Ebola outbreak.
The nucleic acid tests (NATs) presently used to diagnose Ebola require well-established laboratories and fully trained personnel, with a turnaround time that can vary between 12 and 24 hours. In comparison, Corgenix’s test can provide results within 15 minutes by detecting Ebola protein in the blood rather than nucleic acid. While less accurate than NATs, the ReEBOV Antigen Rapid Test Kit is also easy to perform and does not require electricity, making it possible for healthcare workers to use it at less sophisticated healthcare facilities or in mobile units for patients in remote settings.