APEX

Actionable, Personalized, EXpress

APEX Tissue is a 58-gene, targeted Next-Generation Sequencing (NGS) hotspot panel, which is specially curated for the detection of sensitizing and resistance genetic alteration to guide personalized treatment selection in key cancer types.

APEX

Actionable, Personalized, EXpress

APEX Tissue

APEX Tissue is a 58-gene, targeted Next-Generation Sequencing (NGS) hotspot panel, which is specially curated for the detection of sensitizing and resistance genetic alteration to guide personalized treatment selection in key cancer types.

Test Features

Fast Results

Short turnaround time of
4 working days* to allow quicker treatment initiation

Affordable

Competitively priced for greater affordability and accessibility

Targeted

Targeted hotspot sequencing of 58 genes specially curated based on clinical actionability

DNA & RNA

Profiling both DNA and RNA for reliable detection of genetic alterations

Validated

APEX Tissue has been clinically validated

More Information

Profiling various types of genetic alterations, such as SNVs, InDels, amplifications, and fusions, in a single test

Guidelines

Including treatment recommendations based on FDA approvals, NCCN and ESMO guidelines

Concise Report

Easy-to-read report with tier classification of variants for quick decision making

*Counting from the day the specimen is received at our laboratory in Singapore. SNVs: single nucleotide variants; InDels: insertions and deletions.

Genetic Biomarkers Relevant in Various Solid Tumors
Cancer Type Associated Genes
Lung ALK, BRAF, EGFR, ERBB2, KEAP1, KRAS, MET, NRG1, NTRK1/2/3, ROS1, RET, SMARCA4, STK11
Breast AKT1, BRAF, CDK4, CDKN2A, EGFR, ERBB2, ESR1, FGFR1, MAP2K1, MTOR, NTRK1/2/3, PIK3CA, PTEN, RB1, RET
Colorectal ALK, BRAF, ERBB2, FGFR1, KRAS, NRAS, NTRK1/2/3, PIK3CA,POLE, PTEN, RET, ROS1
GIST BRAF, ERBB2, FGFR1, KIT, NTRK1/2/3, PDGFRA, RET
Cholangiocarcinoma / Biliary / Gallbladder BRAF, ERBB2, FGFR2, IDH1, KRAS, MET, NTRK1/2/3, PIK3CA, RET
Melanoma BRAF, ERBB2, HRAS, KIT, KRAS, NRAS, MAP2K1, NTRK1/2/3, RET
Pancreas ALK, BRAF, CDKN2A, EGFR, ERBB2, FGFR1/2/3, KRAS, MET, NRG1, NTRK1/2/3, RET, ROS1
Thyroid ALK, BRAF, CDKN2A, EGFR, ERBB2, FGFR2, HRAS, KIT, KRAS, NRAS, NTRK1/2/3, PIK3CA, RET, ROS1, STK11
Endometrial ALK, BRAF, CDK4, ERBB2, ESR1, FGFR2, KRAS, NTRK1/2/3, PIK3CA, POLE, PTEN, RET, SMARCA4
Small Bowel BRAF, ERBB2, KRAS, NTRK1/2/3, POLE, RET
Stomach / Gastric BRAF, EGFR, ERBB2, MET, NTRK1/2/3, RET
Bladder / Urothelial BRAF, ERBB2, FGFR3, NTRK1/2/3, RET
CNS / Brain BRAF, ERBB2, H3-3A, IDH1, IDH2, NTRK1/2/3, RET, TERT

Note: Not suitable for patients who have failed multiple treatments and exhausted most treatment options. A larger panel may be warranted in these patients

Gene List (58 genes)

First
Ordering Process for Physicians

Step 1

Request a kit online or contact our local representative

Step 2

Obtain informed consent from patient

Step 3

Request tissue slides and histopathology report from pathology laboratory

Step 4

Place all forms and slides in the box provided

Step 5

Contact our local representative to arrange for pickup and courier to Singapore laboratory

Step 6

Receive clinical report after 4 working days from kit receipt at the laboratory

Frequently Asked Questions

APEX stands for Actionable, Personalized and EXpress. It is a 58-gene, targeted hotspot Next-Generation Sequencing panel specially designed for the detection of both drug-sensitizing oncogenic driver alterations and resistance mutations in a single test.

APEX Tissue underwent a series of stringent validation processes, which encompass both analytical and clinical validations. For analytical validation, commercially available industry standards were used to validate the performance of our sequencer in specific laboratory settings. Through the public-private partnership with the Diagnostic Molecular Oncology Centre of National University Hospital, APEX Tissue was also validated using archival clinical specimens with known genetic alterations determined by orthogonal tests to establish the limits of detection for accurate reporting.  

M Diagnostics Pte. Ltd. holds the Healthcare Services Act (HCSA) 2020 License issued by the Ministry of Health (MOH) to operate as a clinical laboratory in Singapore. M Diagnostics has also been a College of American Pathologists (CAP)-accredited laboratory since 2023.

Quality control parameters, such as biomarkers-specific positive and negative call rates and sequencer performance indicators, are tracked and monitored monthly to ensure consistent test performance. These data constitute an important component of the audit documentations for continuous Ministry of Health Singapore licensing and the accreditations by the College of American Pathologists (CAP). The CAP Laboratory Accreditation Program is an internationally recognized laboratory inspection program, which involves a continuous process of self-inspections and external inspections by CAP-assigned inspectors to monitor and improve the laboratory’s overall quality and performance, as well as to achieve the highest standards of excellence in delivering accurate test results that would impact patient care. Besides the CAP accreditation, M Diagnostics also subscribes to the proficiency testing program offered by GenQA, an internationally recognized External Quality Assessment (EQA) provider. This ensures our laboratory proficiency through rigorous and regular external sample testing, individualized and comparative performance feedback, continual education, and alignment with international quality standards—all are fundamental to reliable and high-quality laboratory diagnostics in clinical genomics.

Yes, we can accept FFPE specimens below the minimal requirements. Once we receive such specimens at the laboratory, our customer service team will inform you via email on the same day about the sample receival and the non-conformance of the sample acceptance criteria. Regardless, we will carry on with the extraction of nucleic acids for all cases. If the quantity or quality of the extracted nucleic acids is insufficient or suboptimal, you can then decide whether you want to continue or cancel the test. If you choose to continue the test, you should be aware that there might be a potential risk of failure or false negative result. In the test report, we will clearly indicate these precautions in terms of result interpretation so that an informed judgement can be made.  

Yes, provided the tissue biopsy is not older than 1 year from the date of collection. Based on our laboratory’s experience in processing tissue samples for NGS, sequencing is more likely to fail for samples older than 1 year. However, the stability of DNA and RNA in the tissue biopsy is dependent on tissue processing techniques and storage conditions. The older tissue biopsy may also not reflect the patient’s current tumor biology and mutational profile, especially if the patient has progressed through multiple lines of treatments. Therefore, we highly recommend the submission of the latest tissue biopsy from the patient.

Product nameCOMPASS TissueAPEX Tissue
Number of target genes102158
Panel designComprehensive genomic profiling panelHotspot panel
TechnologyHybridization capture-based Next-generation sequencing, DNA sequencingAmplicon-based Next-generation sequencing, DNA and RNA sequencing
Cancer typesSolid tumorsSolid tumors
Specimen typeFFPE tissueFFPE tissue
Types of genomic alterations covered
  • Single nucleotide variants (SNVs)
  • Insertions and deletions (Indels)
  • Copy number variants (CNVs)
  • Gene rearrangements
  • Single nucleotide variants (SNVs)
  • Insertions and deletions (Indels)
  • Copy number variants (CNVs)
  • Gene fusions
Tumor mutational burden (TMB)*YesNo
Microsatellite instability (MSI)*Yes

No

(available as a separate add-on PCR test)

Homologous recombination repair (HRR) genes coverageYesNo
DNA mismatch repair (MMR) genes coverageYesNo
PharmacogenomicsYesNo
Therapeutic Class Information
  • Chemotherapies
  • Targeted therapies and multi-targeted tyrosine kinase inhibitors (TKIs)
  • Hormonal therapies
  • PARP inhibitors
  • Immune checkpoint inhibitors and immunotherapies
  • Targeted therapies and multi-targeted TKIs
Turnaround time**10 working days4 working days

*Clinical validation for TMB is ongoing.
**Counting from the day the specimen arrives at M Diagnostics laboratory.

MM-022-W_r00

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