Targeted Panel Assays:

Plasma-Safe-SeqS (PSS) Technology

Assays

BC-SEQ

BC-SEQ detects mutations in established and emerging predictive markers, resistance mutations, and frequently occurring genetic alterations in breast cancer.

HNSCC-SEQ

Reliable detection of clinically relevant mutations in HPV-negative HNSCC.

RAS-RAF-SEQ

Detection of mutations in the five most relevant targets for cancers (e.g., colorectal, pancreatic, gallbladder, ovarian, and lung) impacted by the RAS-RAF and PI3K signaling pathways.

AML-SEQ™

Ultra-sensitive detection of the most common Acute Myeloid Leukemia (AML) biomarkers with maximum efficiency.

AML-MRD-SEQ

Reliable detection of AML-MRD relevant and promising mutations. AML-MRD-SEQ detects 68 mutations across 20 genes, including established AML markers, such as IDH1, IDH2, and NPM1, and it demonstrates a significant potential for use as an investigational tool for other markers with prognostic values that are not yet well established.

Plasma-Safe-SeqS panel	Clinically relevant gene regions	Intended uses
RAS-RAF-SEQ	BRAF, KRAS, NRAS, AKT1, PIK3CA	Therapy selection Therapeutic monitoring
HPV-SEQ	HPV 16, HPV 18	Therapy selection Therapeutic monitoring Recurrence surveillance
BC-SEQ	AKT1, ERBB2, ESR1, KRAS, PIK3CA, TP53	Therapy selection Therapeutic monitoring Recurrence surveillance
AML-MRD-SEQ & AML-SEQ	¸FLT3, IDH1, IDH2, NPM1, BCOR, BRAF, CEBPA, GATA2, JAK2, KIT, KRAS, NRAS, PRPF8, PTPN11, SETBP1, SF3B1, SRSF2, TP53, U2AF1, ZRSR2	Therapy selection Therapeutic monitoring MRD detection Recurrence surveillance
HNSCC-SEQ & H&N HPV(-) cancers	CDKN2A, EGFR, ERBB2, FGFR3, HRAS, KRAS, NOTCH1, PIK3CA, PTEN, TP53	Therapy selection Therapeutic monitoring Recurrence surveillance

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cfHPV DNA assay

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Plasma-Safe-SeqS technology platform general test specifications

	Cell-free DNA analysis for solid tumors	Hematological malignancies
Sample types accepted	Whole blood Frozen plasma Purified cfDNA	Whole blood Purified DNA isolated from bone barrow or blood Purified cfDNA
Sample requirements	2x10 mL blood collection tubes required, additional tube may be recommended for certain studies Sysmex Inostics' specimen collection and shipping kits include Streck blood collection tubes Plasma or purified cfDNA from samples collected in Streck or EDTA tubes is acceptable	~5x106 ~10 mL plasma required for cfDNA analysis
Turnaround time	7 – 10 Business days	7 – 10 Business days
Performance	Plasma-Safe-SeqS can detect between 5-7 mutant molecules (95% CI) irrespective of the amount of wildtype DNA present and/or the panel configuration. For 33 ng DNA input, this corresponds to 0.05-0.07% mutant allele frequency (MAF).	Plasma-Safe-SeqS can detect between 5-7 mutant molecules (95% CI) irrespective of the amount of wildtype DNA present and/or the panel configuration. For 33 ng DNA input, this corresponds to 0.05-0.07% mutant allele frequency (MAF).

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