Technical Note SINGLERA · DNA originates from cancer cells. While ctDNA mutations (SNVs, indel,...

SINGLERA Genomics Early cancer detection is vital to improving patient outcomes Circulating tumor DNA (ctDNA) as a cancer marker Tumors or circulating tumor cells release ctDNA into the blood when undergoing apoptosis or necrosis. Approximately 0.1% to 10% of cell-free DNA originates from cancer cells. While ctDNA mutations (SNVs, indel, and CNAs) can be used as markers for cancer detection, the signals can be noisy due to molecule loss during library construction, PCR artifacts, and sequencing errors. PanSeer reduces noise by looking for distinct tumor- specific methylation patterns in adjacent methylation sites. The ctmDNA (circulating tumor methylated DNA) technology interrogates over 12,000 methylation marker patterns. Noise is also reduced by employing a highly efficient targeted sequencing library construction method. Blood Draw Plasma Separation DNA Extraction PanSeer Assay 1 day workflow Sequencing Proprietary Analysis Singlera Genomics Inc. 505 Coast Blvd South Ste 307, La Jolla, CA, 92037, USA Tel: 1 858 732 0061, Email: [email protected] Web: www.singlera.com Late stage cancers often lack an effective treatment option. Five-year survival rates for certain cancers, such as colon cancer, are as high as 92% if detected in stage I; however, the survival rate drops dramatically as cancer progresses to later stages. DETECTED EARLY DETECTED LATE 2 of 10 survive 5 years 9 of 10 survive 5 years PanSeer Non-invasive early cancer detection For research use only. Not for diagnostic purposes. American Cancer Society. Cancer Treatment & Survivorship Facts & Figures 2016-2017. Atlanta: American Cancer Society; 2016 Technical Note

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Transcript of Technical Note SINGLERA · DNA originates from cancer cells. While ctDNA mutations (SNVs, indel,...

SINGLERA

Genomics

Early cancer detection is vital to improving patient outcomes

Circulating tumor DNA (ctDNA) as a cancer marker

Tumors or circulating tumor cells release ctDNA into the blood when undergoing apoptosis or necrosis. Approximately 0.1% to 10% of cell-free DNA originates from cancer cells. While ctDNAmutations (SNVs, indel, and CNAs) can be used as markers for cancer detection, the signals can be noisy due to molecule loss during library construction, PCR artifacts, and sequencing errors.

PanSeer reduces noise by looking for distinct tumor-specific methylation patterns in adjacent methylation sites. The ctmDNA (circulating tumor methylated DNA) technology interrogates over 12,000 methylation marker patterns. Noise is also reduced by employing a highly efficient targeted sequencing library construction method.

Blood DrawPlasma

SeparationDNA

Extraction

PanSeerAssay

1 day workflow

SequencingProprietary

Analysis

Singlera Genomics Inc.505 Coast Blvd South Ste 307, La Jolla, CA, 92037, USA Tel: 1 858 732 0061, Email: [email protected] Web: www.singlera.com

Late stage cancers often lack an effective treatment option. Five-year survival rates for certain cancers, such as colon cancer, are as high as 92% if detected in stage I; however, the survival rate drops dramatically as cancer progresses to later stages.

DETECTED EARLY DETECTED LATE

2 of 10survive 5 years

9 of 10survive 5 years

PanSeerNon-invasive early cancer detection

For research use only. Not for diagnostic purposes.

American Cancer Society. Cancer Treatment & Survivorship Facts & Figures 2016-2017. Atlanta: American Cancer Society; 2016

Technical Note

Post-diagnosis

89.4%161/180

Years prior to diagnosis

0-1 Year

71.0%22/31

1-2 Years

76.9%30/39

2-3 Years

74.5%35/47

3-4 Years

61.9%26/42

92.6%461/498

PanSeer can detect cancer up to 4 years prior to conventional diagnosis

PanSeer performance by covariate analysis

Singlera Genomics Inc.505 Coast Blvd South Ste 307, La Jolla, CA, 92037, USA Tel: 1 858 732 0061, Email: [email protected] Web: www.singlera.com

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11

Taizhou Longitudinal Study

Blood Sample Collection

Participant Monitoring

The Taizhou Longitudinal Study monitored the health of ~120,000 participants over the course of 2008-2018. Plasma samples were collected at the start of the study and participant health was monitored regularly over this time period. 1,379 randomly selected samples were used to train and test the PanSeer assay.

ROC for post- and pre-diagnosis samples(Star shows cutoff from training set)

Sensitivity in post-diagnosis samples by stage Sensitivity in post-diagnosis samples by tissue

~120,000Participants

PanSeer results in blinded test samples

For research use only. Not for diagnostic purposes.

Sensitivity

Specificity

Wang X. et al. (2009). Rationales, design and recruitment of the Taizhou Longitudinal Study. BMC public health, 9(1), 223.

Healthy

Technical Note