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Arrayit Corporation (ARYC) leads and empowers the genetic, research, pharmaceutical, and diagnostic communities through the discovery, development and manufacture of proprietary life science technologies and consumables for disease prevention, treatment and cure.

OvaDx® Ovarian Cancer Diagnostic Test

In Development
OvaDx®_Ovarian_Cancer_Test
Arrayit Corporation and Avant Diagnostics, Inc. provide the market’s first large panel biomarker monitoring test for ovarian cancer (OVC). OvaDx® is advanced microarray-based test that measures the activation of the immune system in blood samples in response to early stage ovarian tumor cell development. Research studies with OvaDx® indicate high sensitivity and specificity for all types and stages of ovarian cancer including stage IA-IV borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous, and ovarian adenocarcinoma. Upon FDA approval, Avant will offer OvaDx® as an elective test for women seeking greater wellness and for women in the elevated risk category for ovarian cancer. OvaDx® will be used by doctors to advance the forefront of ovarian cancer treatment including improved surgical options, more effective chemotherapies, and to supplement existing tests including CA-125, OVA1®, and transvaginal ultrasound.

Click here to read the article featuring Arrayit OvaDx® and Angelina Jolie.

Table of Contents

  • Introduction
  • Quality Control
  • Test Description
  • Patient Samples
  • Test Results
  • Technical Assistance
  • Troubleshooting Tips
  • Recommended Products
  • Product Information
  • Warranty

Introduction
Arrayit Corporation and Avant Diagnostics, Inc. have developed a advanced monitoring test for ovarian cancer diagnostics.

Quality Control
The Arrayit Corporation and Avant Diagnostics, Inc. OvaDx® test is manufactured using the highest level of quality control (QC) and quality assurance (QA) available. Quality control and quality assurance of each manufactured test ensures that OvaDx® performance will meet or exceed the highest diagnostics standards.

Test Description
OvaDx® is an advanced microarray-based diagnostic test that measures the activation of the immune system in response to ovarian tumor cell development. Patient sera are applied to OvaDx® microarrays to allow binding between proteomic biomarkers in the patient samples and capture agents on the microarrays. The microarrays are washed and scanned to produce a digital readout for each serum sample, and the data are quantified and analyzed in software to generate the test results. Clinicians will appreciate the following feaures of this product:

  • Market’s first large panel monitoring test for ovarian cancer
  • Use an elective screen for women seeking greater wellness
  • Screen women at elevated risk for ovarian cancer
  • High sensitivity and specificity for all types and stages of ovarian cancer
  • Research studies based on the screening of 257 total samples
  • 79.7% combined sensitivity based on 55 of 69 OVC samples scored as positive
  • Specificity determined by screening 178 samples from healthy patients and 10 samples from patients with benign gynecological conditions
  • 100% specificity based on 188 of 188 non-OVC samples scored as negative
  • Identifies stage I, II, III and IV disease markers in patient samples
  • Detects stage IA disease markers with ~80% sensitivity
  • Detects borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous, and ovarian adenocarcinoma in patient sera
  • Multi-plexed microarray assay reads approximately 100 proteomic biomarkers
  • Proteomic panel provides definitive real-time test results
  • Microarray format reduces serum requirement to 0.1-0.25 ml per sample run
  • Blood cards can be used for sample collection
  • Fluorescence detection ensures high signal detectivity
  • Test controls eliminate experimental false positives and false negatives
  • High-throughput format scales to any number of patient samples
  • Automated process permits large-scale (e.g. 1,000,000 sample+) screening
  • Supplement OVA1® and other multi-analyte tests
  • Supplement single marker tests including cancer antigen 125 (CA-125) and human epididymis protein (HE4)
  • Supplement genetic tests including BRCA1 and BRCA2
  • Supplement imaging techniques including transvaginal ultrasound, computerized tomography (CT) scans, and x-rays
  • Screen patient sera from breast, cervical, uterine and other cancer patients
  • Test samples from patients with ovarian cysts and other benign conditions

OvaDx
OvaDx® Blood Cards. Patient samples for OvaDx® diagnostic testing can be submitted using Arrayit Corporation blood cards. Place 5 large drops of fresh patient blood inside the red box of a new card. Arrayit’s unique competitive linear transfer chromotography technology partitions the whole blood components from left to right such that the serum containing the OvaDx® biomarkers separates cleanly from the red blood cells in 1 minute. Please allow the card to dry for 10 minutes prior to mailing. Dried cards should be placed in the airtight mailing envelopes supplied with the sampling kit and mailed to our Sunnyvale laboratories for testing.

Patient Samples
Fresh blood (0.5-1.0 ml) should be drawn intravenously and collected in a red-top tube with no additive. Samples should be centrifuged immediately for 5 min at 6,000 rpm (2,000 x g) to isolate the serum fraction (top layer). The serum (0.1-0.25 ml) should be transferred to a fresh microfuge tube or sample vial and frozen immediately at -20°C or -70°C. Previously prepared samples stored at -20°C or -70°C are also acceptable. Blood samples can also be collected using blood cards provided by Avant Diagnostics, Inc. Samples should be labeled unambiguously with a permanent marker, adhesive label or by barcoding. Frozen Samples should be shipped overnight on dry ice with sample annotation and complete clinician contact information and blood cards should be shipped at room temperature:

Arrayit Corporation
Receiving Department
927 Thompson Place
Sunnyvale, CA 94085
USA
Telephone: (408) 744-1331

Test Results
Avant Diagnostics, Inc. provides a full report for each patient sample including benchmarks for the following experimental parameters:

  • Sample integrity (pass/fail)
  • Protein concentration (pass/fail)
  • Spectrophotometric (pass/fail)
  • Assay background (pass/fail)
  • Assay uniformity (pass/fail)
  • Positive controls (pass/fail)
  • Negative controls (pass/fail)
  • Capture agents (numerical score)
  • Diagnostic result (positive or negative)

Technical Assistance
Please contact us if you have any comments, suggestions, or if you need technical assistance. We can be reached at all hours by electronic mail (arrayit@arrayit.com) or by telephone (408-744-1331) from Monday-Friday 8:00 AM-6 PM  PST. Please remember that we want to hear about your successes!

Troubleshooting Tips

  • Serum samples appear cloudy: make certain to centrifuge at 2,000 x g for 5 min
  • Blood cards lack sufficient serum: collect at least 4-5 drops of blood
  • Serum samples have insufficient protein concentration: make certain to use undiluted whole blood
  • Assays show high background: top serum layer should be transferred to a new tube immediately after centrifugation
  • Positive controls fail: re-test using new serum samples
  • Negative controls fail: re-test using new serum samples

Recommended Products
VIP genotyping platforms
Biomarker discovery services
Microarrayers
Microarray scanners
Microarray printing
Microarray substrate slides
Amplification and labeling
DNA microarrays
Microarray services
Microarray buffers
Microarray tools
Microarray instruments

Product Information

Product

Description

Cat ID

OvaDx® Ovarian Cancer Diagnostic Test

OvaDx® Large Panel Ovarian Cancer Biomarker Diagnostic Test with high sensitivity and specificity for all types and stages of ovarian cancer patient samples including stage IA-IV borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous, and ovarian adenocarcinoma. Patient samples should be shipped on dry ice or room temperature for blood cards according to the instructions provided above. A diagnostic report for each patient sample is included with each test. Diagnostic test results are to be used in accordance with all local, state and federal regulations including those set forth by the United States Food and Drug Administration (FDA).

OVADX

OvaDx® Ovarian Cancer Diagnostic Test, Platform Pricing

OvaDx® Large Panel Ovarian Cancer Biomarker Diagnostic Test with high sensitivity and specificity for all types and stages of ovarian cancer patient samples including stage IA-IV borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous, and ovarian adenocarcinoma. Patient samples including fresh, frozen and blood card samples should be collected and stored according to the instructions provided above. A diagnostic report should be supplied for each patient sample. Patient samples and diagnostic test results are to be used in accordance with all local, state and federal regulations including those set forth by the United States Food and Drug Administration (FDA).

OVADXP

OvaDx® Ovarian Cancer Complete Diagnostic Testing Platform

OvaDx® Large Panel Complete Ovarian Cancer Diagnostic Testing Platform including fluorescence scanner, reaction and processing hardware, quantification software, and 100 OvaDx® tests with high sensitivity and specificity for all types and stages of ovarian cancer patient samples including stage IA-IV borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous, and ovarian adenocarcinoma. Patient samples and diagnostic test results are to be used in accordance with all local, state and federal regulations including those set forth by the United States Food and Drug Administration (FDA).

OVADXCP

Warranty
Arrayit Corporation and Avant Diagnostics, Inc. OvaDx® Large Panel Ovarian Cancer Diagnostic Test has been developed for diagnostic purposes and will be sold for clinical applications upon FDA approval. Extreme care and exact attention should be practiced in the preparation and storage of OvaDx® patient samples and use of the diagnostic information obtained from the test. OvaDx® manufacturing and testing are subject to extensive quality control and are guaranteed to perform as described when used with properly prepared patient samples. Avant Diagnostic’s liability is limited to test replacement only, any misuse of this diagnostic product is the full responsibility of the clinician, and Avant Diagnostics makes no warranty or guarantee under such circumstances.

 

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