VERACITY: Non-Invasive Prenatal Tests

VERACITY is suitable for pregnant individuals of any maternal age or risk category, including:

• Singleton pregnancies
• Twin pregnancies*
• Vanishing twin pregnancies*
• IVF pregnancies (singleton), including those conceived using the patient’s own eggs, donor eggs, or surrogacy
• IVF twin or vanishing twin pregnancies*, including those conceived using the patient’s own eggs, donor eggs, or surrogacy

* Sex chromosome aneuploidy screening is not available for twin or vanishing twin pregnancies.

VERACITY is not suitable for:

• Patients with a current or previous malignancy
• Patients who have received an organ or bone marrow transplant
• Patients who have recently received a blood transfusion

VERACITY enables clinicians to deliver clear, evidence-based results early in pregnancy, facilitating timely counselling, diagnostic follow-up, and coordinated management planning. VERACITY aligns seamlessly with first-trimester combined screening workflows by offering cfDNA-based risk assessment that can be performed alongside ultrasound and biochemical evaluation. When used alongside conventional prenatal screening tests, VERACITY contributes to a more comprehensive assessment of the pregnancy, facilitates clinical counselling, and helps clinicians identify patients who may benefit from further diagnostic testing.

Key reasons to recommend VERACITY include:

• Clinical confidence: validated accuracy across diverse pregnancy types
• Early results: available from week nine, supporting timely patient management
• Reduced invasive procedures: fewer false positives compared to conventional screening
• Guideline alignment: consistent with , , and recommendations for universal cfDNA screening

VERACITY reports results as either:

• Very low risk: A reduced likelihood that the fetus is affected by one of the conditions included in the test.
• Very high risk: An increased likelihood that the fetus is affected by one of the conditions included in the test. Confirmatory diagnostic testing is recommended.

Fetal fraction: The fetal fraction, representing the proportion of fetal cell-free DNA in the maternal blood sample, is accurately measured and reported for every sample using validated bioinformatic analysis, in accordance with the position statement (Gregg et al., 2016).

Result interpretation

Every report includes:

• A concise, standardised interpretation of the findings
• Clear recommendations for appropriate clinical follow-up
• Guidance on confirmatory diagnostic testing when indicated

VERACITY is a screening test, not a diagnostic test. A very high risk result should always be confirmed by an appropriate diagnostic procedure.

Following receipt of the VERACITY report, healthcare providers should:

• Communicate the results to the patient
• Provide or recommend genetic counselling, when appropriate
• Confirm any very high-risk result through an appropriate prenatal diagnostic procedure
• Discuss available clinical management options based on the confirmed diagnosis and individual patient circumstances

Genetic counselling is a specialised, patient-centred, impartial, and non-directive communication process that supports patients and their families both before and after genetic testing.

Prior to genetic testing, genetic counsellors obtain a detailed medical and family history and provide education on genetic concepts, the testing process, and available options, along with the potential risks, benefits, limitations, and possible outcomes.

Upon receiving genetic test results, genetic counsellors assist in interpreting the findings and guide individuals through the implications for their own personal health and that of their family members. During post-test counselling, genetic counsellors also provide evidence-based recommendations on next steps, including strategies for prevention, surveillance, and management.

The goal of genetic counselling is to empower patients through knowledge and tailored support, enabling them to make informed and voluntary decisions.

VERACITY uses targeted next-generation sequencing (NGS) technology to identify common fetal chromosomal abnormalities and clinically significant microdeletion syndromes. The assay has been extensively validated to provide accurate, reliable, and reproducible prenatal screening.

The targeted sequencing approach focuses on clinically relevant genomic regions, reducing background noise and enabling high read-depth analysis to support accurate fetal fraction measurement and reliable detection of fetal chromosomal abnormalities.

The assay is designed to detect:

• Common autosomal trisomies (Trisomy 21, Trisomy 18 and Trisomy 13)
• Sex chromosome aneuploidies
• Selected clinically significant microdeletion syndromes

Sequencing data are analysed using validated bioinformatic pipelines that support the accurate identification and classification of clinically relevant chromosomal abnormalities.

The assay has been validated to provide reliable performance in samples with fetal fractions as low as 3%.

The targeted sequencing approach enables the detection of microdeletions as small as 1 Mb, including nested microdeletions and microduplications within targeted genomic regions.

Proven clinical performance

VERACITY has been extensively evaluated through peer-reviewed publications and comprehensive analytical and clinical validation studies. Using a targeted next-generation sequencing approach, the assay demonstrates high sensitivity, specificity and reproducibility for the detection of common fetal aneuploidies, sex chromosome aneuploidies and clinically significant microdeletion syndromes.

Clinically focused microdeletion screening

VERACITY focuses on a carefully selected panel of clinically significant microdeletion syndromes. Its targeted sequencing approach provides deep coverage of clinically relevant genomic regions and is validated to detect microdeletions as small as 1 Mb, including 22q11.2 deletion syndrome (DiGeorge syndrome).

Performance highlights

• High accuracy for the detection of common autosomal trisomies
• High sensitivity and specificity across common trisomies, sex chromosome aneuploidies and clinically significant microdeletion syndromes
• Reliable performance in samples with fetal fractions as low as 3%
• Consistent analytical and clinical performance demonstrated through extensive validation studies

Clinical performance based on internal data of 60,000 samples

Important notice: VERACITY NIPT is a screening test, not a diagnostic test. A high-risk result should always be confirmed by invasive diagnostic testing such as amniocentesis before any clinical decision is made. VERACITY is validated for singleton, twin, and vanishing twin pregnancies, including IVF and donor-egg cases, but is not suitable for patients with recent transfusions, transplants, or malignancies. Availability and test panels may vary by region and regulatory status.

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