By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: New Blood Test Can Detect Developmental Delays in Babies Post-Pregnancy
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Innovations > New Blood Test Can Detect Developmental Delays in Babies Post-Pregnancy
DiagnosticsMedical InnovationsSpecialtiesTechnology

New Blood Test Can Detect Developmental Delays in Babies Post-Pregnancy

Susan Scutti
Susan Scutti
Share
0 Min Read
SHARE

developmental delays blood testAffymetrix’s CytoScan Dx Assay, which can detect chromosomal variations linked to developmental delays or intellectual disabilities in children, has been granted 

developmental delays blood testAffymetrix’s CytoScan Dx Assay, which can detect chromosomal variations linked to developmental delays or intellectual disabilities in children, has been granted marketing approval by the Food and Drug Administration (FDA) today. “This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child,” said Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA. An intellectual disability, which affects between one and three percent of the population, is a condition diagnosed before age 18 that includes below-average intellectual function and a lack of skills necessary for daily living.

Requiring an infant’s blood sample, the genotyping assay is meant to aid diagnosis of an intellectual disability. The FDA’s review of the CytoScan Dx Assay included evaluation of the test’s ability to accurately detect numerous chromosomal variations of different types, sizes, and genome locations. Such “genotyping” is the process of determining a person’s genetic constitution — the entirety of their genes, the sequences of code inherited from each parent that include, in some cases, sequence changes due to environmental damage or biological errors. Many intellectual and developmental disabilities, such as Down syndrome and DiGeorge syndrome, are associated with chromosomal variations, according to the National Institutes of Health. One of the most common forms of genetic variation, as described by Affymetrix, is a single-nucleotide polymorphism, or SNP, which is a variation in a single position in a DNA sequence. Another common aberration is copy number variations, or CNV, which is a variation in the number of copies of a segment of the DNA. In its evaluation, the FDA also compared the assay to several commonly used test methods, including karyotyping and FISH chromosomal tests and found that in 960 blood specimens, CytoScan had a better ability to detect certain chromosomal abnormalities.

“The FDA’s review of the test provides clinical laboratories with information about the expected performance of the device and the quality of the results,” Gutierrez noted. A primary FDA expectation is that test results be performed and interpreted by properly certified health care professionals. Additionally, the agency noted the device should not be used for prenatal testing or screening, pre-implantation testing or screening, population screening, or for the detection of aberrations occurring after birth, such as cancer. Last year, GenomeWeb reported that Doug Farrell, the company’s director of investor relations, said gaining FDA clearance would be unlikely to “change the trajectory of the [CytoScan] business dramatically” though it would give the company an advantage in winning new customers.

(image: shutterstock)

TAGGED:CytoScan
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

dental care
Importance of Good Dental Care for Health and Confidence
Dental health Specialties
October 2, 2025
AI in Healthcare
AI in Healthcare: Technology is Transforming the Global Landscape
Global Healthcare Policy & Law Technology
October 1, 2025
Choosing the Right Swimwear for Health and Safety
News
September 30, 2025
sports concussions
Concussion In Sports: How Common They Are And What You Need To Know
Infographics
September 28, 2025

You Might also Like

Health careSpecialtiesWellness

Top Three Essentials for General Health Care during Pregnancy

January 13, 2019

2015 Health IT Predictions and Reflections

January 9, 2015
Dental healthSpecialties

11 Overlooked Flossing and Brushing Mistakes that Cause Oral Health Issues

July 2, 2019
biopharma beat diagnostics
DiagnosticsMedical DevicesMedical EducationMedical InnovationsPublic HealthTechnologyWellness

BioPharma Beat: The Promise of Diagnostics and Precision Medicine

November 4, 2013
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?