The Clinical Use

  • Provides information for clinically actionable genomic alterations and their associatedtargeted therapy, both approved and in clinical trials.
  • Evaluates TMB and MSl to better inform immunotherapy decisions.
  • Predicts efhcacy and toxicity of chemotherapy based on associated genetic biomarkers.
  • Reveals potential resistance mechanism(s) to current therapies and options foralternative treatments.
  • Assesses genetic predisposition to certain cancer types for early intervention.
  • Information about the likely outcome of disease (your patients’ prognosis).

 

 

The Clinical Background

  • National Comprehensive Cancer Network (NCCN®) guidance reflects more recent Food and Drug Administration (FDA) approvals of targeted therapies. They recommend testing solid tumor  specimens for genomic variants and biomarkers that could potentially offer effective therapeutic options. Gene selection and product design are carried out in conjunction with authoritative journals such as NEJM and JCO.
  • Many of these variants serve as predictive biomarkers for response to targeted therapies and immunotherapies. High TMB (TMB-H) and MSI (MSI-H) are predictive biomarkers of response to treatment with immune checkpoint inhibitors.

 

 

The Suitable Individuals

People with solid tumors whose diagnosis, prognosis, or treatment selection could be informed by the presence of genomic variants and MSI/TMB status.

 

 

The Solutions

The AcornOne808 analyzes genes primarily associated with onset conditions across major organ systems, including but not limited to lung, breast, gynecologic (ovarian, uterine/endometrial), gastrointestinal (colorectal, gastric, pancreatic), thyroid, genitourinary (renal/urinary tract, prostate), melanoma, and so on. Sequencing of over 800 genes, identified as relevant to cancer treatment, as well as testing of important immunotherapy biomarkers provides a comprehensive picture for the oncologist to formulate a treatment plan with their patients.

  • CE-approved test
  • Covering genomic regions of 808 genes
  • Uses hybrid capture-based next-generation sequencing (NGS)
  • Identifies the four main classes of genomic alterations (base substitutions, insertions and deletions, copy number alterations, and fusions

 

 

Biomarkers and companion diagnostic drugs

BIOMARKERS

FDA-APPROVED THERAPY

EGFR exon 19 deletions & EGFR exon 21 L858R alterations

EGFR Tyrosine Kinase Inhibitors (TKI)

EGFR exon 20 T790M alterations

Tagrisso® (osimertinib)

EGFR exon 20 insertion

Rybrevant® (amivantamab-vmjw), Exkivity® (mobocertinib)

ALK fusions

Alecensa® (alectinib), Alunbrig® (brigatinib) Xalkori® (crizotinib), or Zykadia® (ceritinib), Lorbrena® (Lorlatinib)

ROS1 fusions

Xalkori® (Crizotinib), Rozlytrek® (entrectinib), Augtyro® (repotrectinib)

RET fusions

Retevmo® (Selpercatinib), Gavreto® (pralsetinib)

MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping

Tepmetko® (tepotinib), Tabrecta® (capmatinib)

BRAF V600E

Braftovi® (encorafenib) in combination with Mektovi® (binimetinib), Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib)

KRAS G12C

Lumakras® (sotorasib), Krazati® (adagrasib)

ERBB2

Enhertu® (trastuzumab deruxtecan)

BIOMARKERS

FDA-APPROVED THERAPY

KRAS wild-type (absence of mutations in codons 12 and 13)

Erbitux® (cetuximab)

KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4)

Vectibix® (panitumumab)

 

BRAF V600E

Braftovi® (encorafenib) in combination with Erbitux® (cetuximab)

BIOMARKERS

FDA-APPROVED THERAPY

BRCA1/2

Akeega® (niraparib/abiraterone acetate) in combination with Prednisone.

Lynparza (Olaparib) in combination with abiraterone and prednisone or prednisolone. Rubraca® (Rucaparib)

HRR (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L)

Lynparza® (Olaparib)

HRR (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C)

Talzenna® (Talazoparib)

BIOMARKERS

FDA-APPROVED THERAPY

FGFR3

Balversa® (Erdafitinib)

BIOMARKERS

FDA-APPROVED THERAPY

MSI-High

Keytruda® (Pembrolizumab)

TMB-H(≥10 (mut/Mb)

Keytruda® (Pembrolizumab)

NTRK1/2/3 fusions

Rozlytrek® (entrectinib), Vitrakvi® (Larotrectinib)

RET fusions

Retevmo® (Selpercatinib)

Flowchart

Flowchart