We find purpose in the work we do

Our Beginning

NIPS is a blood-based genetic, prenatal screening test of the pregnant person that screens for common chromosomal conditions that affect a baby’s health.

This test, performed on the Illumina VeriSeq NIPS Solution v2 platform, uses counting-based analysis to determine the probability that certain regions of the genome are over- or underrepresented. Data are generated through massively parallel whole genome sequencing. This process analyzes cell-free DNA (cfDNA) to generate paired-end data that are then compared with a reference genome. The comparisons help detect the likelihood of chromosomal abnormalities in the fetus. Results are reported as aneuploidies detected or not detected.

NIPS delivers more accurate than maternal serum screening methods for detecting fetal chromosome aneuploidies and is used for screening in women carrying a single fetus or twins and can be performed as early as 10 weeks into a pregnancy. It requires a maternal blood draw and carries no risk of miscarriage. The high-efficiency screening process is also fast and can deliver results to patients within five to seven days.

Verifi™ is a screening test, which means that this test does not make a final diagnosis. A positive result means that your pregnancy has a higher chance of having a specific genetic condition. However, you cannot know for sure if your baby has that condition based upon the screening result alone. All medical decisions should be made after discussion with your care team regarding diagnostic testing during the pregnancy, like chorionic villus sampling (CVS) or amniocentesis, or testing the baby after birth.

Developing SignatureDx

Upon their introduction through a mutual friend in 2019, Colaizzi learned about Peters’ background in genetics and his research on developing non-invasive methods to detect and analyze diseases. At the time, Colaizzi’s focus was on the field of pharmacogenetics (PGX) which included operating a testing lab called Genelex. After Genelex was acquired by a genetic company called Invitae, Colaizzi and Peters began collaborating on a business plan for commercializing Peters’ work.

During development in late 2019, Colaizzi was introduced to Dr. Tianjao Chu, a biostatistician and close colleague of Peters, who soon became the Chief Analytical Officer of Signature. The three colleagues now make up the company’s leadership team, with Colaizzi serving as Chief Executive Officer and Peters as Chief Science Officer.

Colaizzi and Peters distinguished the company’s research from its daily lab operations by opening SDxLabs. The lab worked to obtain certification from the Clinical Laboratory Improvement Amendments (CLIA) in March of 2021, and by July, the lab met all CLIA requirements to become operational. By implementing testing for COVID-19 as one of the lab’s offerings, SDxLabs was able to meet the increasing need for COVID tests in the community while establishing an infrastructure for the lab, both commercially and for research purposes.

While SDxLabs continues to offer testing for COVID-19, the heart of Signature exists through expanding the research of noninvasive technologies for the purpose of early disease detection. Led in science by Peters, Signature is actively involved in research surrounding early-stage detection of complex diseases using liquid biopsies, both relating to women’s reproductive health and organ health. In collaboration with the University of Pittsburgh and Magee-Womens Research Institute, Signature’s approach utilizes DNA sequencing to identify biomarkers which determine genetic signatures. With the introduction of noninvasive prenatal screening (NIPS) into the lab’s offerings, Signature remains committed to increasing the knowledge and understanding of complex diseases.

About - Mission

Our mission

Our mission is to spearhead research in advanced diagnostics to develop novel methods for the early detection of complex human disease.

Our vision

Our vision is to change the paradigm of healthcare intervention by enabling the early noninvasive detection of silently progressing disease.

About - Vision

We live and work by our core values

Integrity and Quality

We uphold the integrity and quality of our research so those we serve can put their trust in us to deliver novel methods for the early detection of complex human disease.  

Commitment

We are committed to our approach built around novel DNA methylation analysis to identify risk for the development of a specific disease very early, prior to the onset of symptoms.

Dedication and Impact

We are dedicated to our research to deliver impactful solutions using technology to improve and reshape the healthcare sector.

Passion

Our passion for proactive medicine and early intervention drives us to create new, noninvasive diagnostic tests that elevate patient comfort and lower their risk of complications during diagnostic procedures.

Collaboration

Our multi-disciplined team collaborates to provide a holistic, unique approach to developing solutions that will improve health outcomes for patients and providers.