Oncology

In Vitro Diagnostic Tests Designed To Detect Internal Tandem
Duplication (Itd) Mutations And The Tyrosine Kinase Domain (Tkd) Mutations

Leukemia Detection With Leukostrat Cdx Flt 3 Mutation Assay 2.0

The LeukoStrat CDx FLT3 Mutation Assay is performed at the Laboratory for Personalized Molecular Medicine (LabPMM) LLC and the interpretive comments are provided by Versiti.

Indications For Testing:

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to detect internal tandem duplication (ITD) mutations and the tyrosine kinase domain (TKD) mutations D835 and I836 in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myeloid leukemia (AML).

The LeukoStrat CDx FLT3 Mutation Assay is the only FD Aapproved predictive test for the efficacy of gilteritinib (XOSPATA®) therapy in relapsed or refractory acutemyeloid leukemia (AML) patients. Relapsed or refractory AML Patients with a detectable FLT3 mutation above the clinical cut-off of signal ratio 0.05 are indicated forgilteritinib (XOSPATA®) therapy.

Assay Description:

The LeukoStrat CDx FLT3 Mutation Assay is a PCR based test designed to detect internal tandem duplications (ITD) and tyrosine kinase (TKD) mutations in the FLT3 gene.

ITD: The duplication and insertion of a portion of the FLT3 gene that includes the region in and around the juxtamembrane region of the FLT3 gene.

TKD: Nucleotide(s) changes at codon 835 and/or 836 that are detected by inactivation of the EcoRV restriction digestion site within the tyrosine kinase domain for the FLT3 gene. The polymerase chain reaction is performed on DNA isolated from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myeloid leukemia. Fluorescently labeled primers are used to amplify the sequences of interest. The TKD PCR product is digested with the Eco RV restriction enzyme. The ITD PCR products and the digested TKD PCR products are run on an ABI 3500xL Genetic Analyzer and their sizes determined.

STRONG PERFORMANCE METRICS

LabPMM tested 57 blinded patient samples obtained from three independent institutions. The institutions determined that 13 of the samples were FLT3 ITD positive, 33 were FLT3 ITD negative, 6 were FLT3 TKD positive, and 50 were FLT3 TKD negative. In addition 10 positive blinded spiked samples and 10 negative samples were used for the validation of FLT3 TKD. The LeukoStrat FLT3 Mutation Assay showed a sensitivity and specificity of 100% with both master mixes. The analytical sensitivity of both master mixes was determined to be 5 positive cells out of 100 total cells.

CERVICAL CANCER SCREENING DEVICES

Cervical cancer is caused by a sexually acquired infection with certain types of HPV.

● Two HPV types (16 and 18) cause 70% of cervical cancers and pre-cancerous cervical lesions.
● Cervical cancer is the fourth most common cancer among women globally, with an estimated 570,000 new cases in 2018.
● Screening and treatment of pre-cancer lesions in women is a cost-effective way to prevent cervical cancer.
● HPV DNA testing for high-risk HPV types is one of types for screening tests that are currently recommended by the WHO.

Introducing a high-throughput, One-tube fast release technology for HPV PCR testing. The kits can be paired with mPOCT (iPonatic) to enable a break through in molecular diagnostic technology with results in mere seconds (<30min). In line with WHO’s strategy to accelerate the elimination of cervical cancer, our strategic partners are committed to making genetic science and technology available to the general public to acceleratethe ultimate elimination of cervical cancer and improve the health of all women.

HPV DNA EXTRACTION AND PURIFICATION TECHNOLOGY

HPV DNA Detection Workflow

One-Tube Fast Release Technology

One-tube fast release technology is the world’s leading PCR detection technology in the industry. Adopting Sansure’s patent nucleic acid release technology, can quickly lyse pathogens at room temperature, no need for heating, centrifuging or replacing tubes.

DNA and RNA samples can be extracted quickly through a simple operation that combines an efficient amplification system to ensure a high sensitivity and wide linear range RT-PCR detection with good reproducibility, strong anti-interference ability and coverage for multiple genotypes.

EXTRACTION AND AMPLIFICATION KITS

EXTRACTION AND AMPLIFICATION UNITS