November 7, 2024

Since the emergence of non-invasive prenatal testing (NIPT) using maternal blood as a source of fetal DNA for genetic defect assessment, the maternal serum screen testing landscape has evolved. In particular, changes at the national organizations providing quality assessment/certification for fetal ultrasonography have impacted Warde’s ability to continue screening panels that use fetal measurements in conjunction with serum markers. Warde’s test codes of FINT1, FTS1, and SEQ1, will be discontinued as of 12/9/24. Although the two-part serum integrated screen (INTG1) does not incorporate ultrasonographic inputs, this test is also being discontinued due to very low volumes. Second trimester Quad screening (QUAD1), and stand-alone AFP testing (MAFP1), will remain available.

**Note that two-part screens will still be completed if the first specimen is drawn before 12/9: FINT2, SEQ2, and INTG2 codes will remain available to report second trimester results for patients who were drawn for FINT1, SEQ1, and INTG1 before December 9, 2024.**

From discussion with clients and review of testing volumes, use of first trimester, sequential, and integrated screens was already in decline, and many institutions have existing plans to transition towards NIPT. NIPT is offered through Warde (as a sendout to Natera, under code PAN). Note that Natera Panorama can be used for twins, but not triplets or greater multiple gestation; it cannot be used for cases of surrogacy or egg donor use, or for recipients of a bone marrow transplant. As NIPT evaluates fetal DNA circulating in maternal blood, it does not replace AFP testing for neural tube defects.

Effective December 9, 2024, the following timelines will be in place for prenatal testing:

*There will be no Warde biochemical assays for assessing risk of fetal defects prior to 15 weeks of pregnancy

-Starting at 9 weeks of pregnancy, Natera’s Panorama prenatal screens can be used to screen for chromosomal abnormalities (PAN, PAN22, PANFP).

-At 15 weeks, and up until 22 weeks+6 days, Warde’s Quad screen can be used (QUAD1 assesses risk for Down Syndrome, Trisomy 18, and neural tube defects).

-At 15 weeks, and up until 22 weeks+6 days, Warde’s AFP screen (MAFP1) can assess for neural tube defect risk (note that NIPT does not assess for neural tube defects).