Solution
for
better decision

ABOUT ISTAT

MISSION AND VISION

Use of real-world data and technological innovation to improve an existing diagnostic approach, establishment of personalized disease control strategy, and development of comprehensive solution against precancers to meet the goal of early diagnosis and treatment.

COMPANY PROFILE

iStat Biomedical Co., Ltd. was founded in 1994, as a health data sciences company that provides study design, data collection, statistical analysis and publication services for hospital-based clinical trials and community-based epidemiological studies. In 2009, iStat expanded beyond health data sciences and developed its capacity in the medical device industry, specializing in the development and manufacturing of advanced gene methylation assay products for early detection of various cancers, including cervical, oral, and bladder cancers.

ABOUT ISTAT

diagnostic
products
healthcare
big data
precision
medicine

PRODUCTS AND SERVICES

PRODUCT DEVELOPMENT
DNA methylation detection kit for
cervical cancer
DNA methylation detection kit for
oral cancer
LABORATORY SERVICE
DNA methylation test services for
cervical cancer
DNA methylation test services for
oral cancer
CONTRACT SERVICES
Development and manufacturing services for in vitro diagnostics products
Consulting services for clinical- and population-based studies
Analytical services for real world evidence studies

CERTIFICATION

Taiwan Pharmacist manufacturing license
Good manufacturing practice for
medical device
ISO13485 Quality management system
TAF ISO17025 (Taiwan accreditation foundation)
CE-mark in vitro diagnostics
EpiGene Specimen collection and
transport tube (TFDA Class 1 IVD market approval)
EpiGene Bisulfite conversion kit (TFDA Class 1 IVD market approval)
EpiGene PAX1 DNA methylation detection kit (TFDA Class 3 IVD market approval)

CORE TECHNOLOGY

Methylation specific PCR procedure

PRODUCTS

ORAL PRECANCER
LESION & CANCER

Oral-M®

Expert of Oral Lesion

Collects epithelial cells from oral ambiguous lesions and qualitatively detects methylation level of ZNF582. This test aids physicians in visual oral examination for the assessment of the risk of developing oral cancer.

Users
  • Oral mucosa abnormality discovered during oral screening
  • Frequent alcohol, betel-nut or cigarette consumption
  • Oral chronic inflammation that lasts for 2 weeks or more
  • Symptoms such as leukoplakia or swelling
  • Self-awareness of oral abnormality
  • Health checkup
| Detection advantage |
  • Aid in
    diagnostic
    Objective test to assist
    medical management
  • Quick
    collection
    Only 10 seconds needed,
    simple and convenient
  • Noninvasive
    Neither adverse effect nor
    invasiveness upon
    specimen collection
  • Precision
    prevention
    Personalized
    disease prevention

CERVICAL PRECANCER
LESION & CANCER

Cervi-M®

A Gentle Feminine Safekeeper

Detects DNA methylation from the cervical exfoliated cells applying the methylation-specific PCR, and can be used as an adjunctive tool for cervical cancer and cervical precancer lesions screening.

Users
  • Women 20 years old or above
  • Women having early sexual experience
  • Abnormal cytology or with high-risk types of HPV infection
  • Cancer family history
  • Abnormal uterine bleeding
  • Frequent reproductive tract infection or chronic inflammation
  • Immunocompromised population
  • Women with smoking habit
  • Other populations with high risk in developing cervical cancer
| Detection advantage |
  • Synchronized
    test
    Specimen can be collected
    in conjunction with Pap
    smear and/or HPV test
  • Aid in
    diagnostic
    Objective test to assist
    medical management
  • Professional
    certification
    TFDA Class 3 IVD
    market approval
  • Precision
    prevention
    Personalized
    disease prevention