OncoCyte Corporation (NYSEMKT:OCX) Files An 8-K Regulation FD Disclosure

OncoCyte Corporation (NYSEMKT:OCX) Files An 8-K Regulation FD Disclosure

Story continues below

Item 7.01 – Regulation FD Disclosure

On March 6, 2017, OncoCyte issued the press release attached to
this report as Exhibit 99.1. The content of this Item 7.01 and
Exhibit 99.1 shall be deemed furnished and not filed under
Section 18 of the Securities Exchange Act of 1934, as amended
(the Exchange Act), or otherwise subject to the liability of that
section, and shall not be incorporated by reference into any
filing made by OncoCyte under the Securities Act of 1933, as
amended, or the Exchange Act except as may be expressly set forth
by specific reference in such filing.
Item 8.01 – Other Events
OncoCyte has successfully completed a 300 blood sample study of
the mRNA biomarker-based lung cancer diagnostic test that it is
developing, and has locked the prediction algorithm of the test.
The study confirmed an earlier study of the same biomarkers by
The Wistar Institute of Anatomy and Biology, the results of which
were reported at the CHEST 2016 Annual Meeting in October 2016.
The Area Under the Curve (AUC) in Wistars study was 0.82 with a
sensitivity of 90% and specificity of 62%. OncoCytes study
results were consistent with Wistars and are well above the
levels that OncoCyte believes are necessary for a commercially
successful test based on its own market research. The AUC of a
test is a measure that combines sensitivity and specificity to
express its total accuracy, with 1.0 being perfect accuracy and
0.50 being a random result. Sensitivity and specificity are
statistical measures of test performance, with sensitivity
measuring the percentage of malignant nodules that are identified
correctly by the test and specificity measuring the percentage of
benign nodules correctly identified.
OncoCytes study utilized Wistars biomarker panel, which has been
exclusively licensed to OncoCyte. The study developed and tested
OncoCytes proprietary algorithm using approximately 300 blood
samples collected from patients at 26 sites across the United
States. OncoCyte developed its algorithm by combining data from
the top mRNA biomarkers with clinical data such as nodule size.
The samples were collected from patients with nodules ranging in
size from five to thirty millimeters, the size range presenting
the greatest diagnostic challenge to clinicians. For patients
with these size nodules physicians must weigh the risk of cancer
against the risks posted by invasive biopsies to confirm whether
the nodules are malignant or benign.
Based on the study results, OncoCyte will begin ramping-up its
commercial capabilities in anticipation of the potential
commercial launch of the test. OncoCyte will initiate a clinical
validation phase for the diagnostic. During this phase, OncoCyte
will also continue to carry out analytical validation studies to
refine its operational stage laboratory processes, and will apply
for certification of its CLIA diagnostic testing lab. Upon CLIA
certification, OncoCyte will conduct a small CLIA lab validation
study to demonstrate that the full assay system utilized in the
CLIA lab provides the same results on clinical samples as those
obtained in the RD lab. OncoCyte will then begin a clinical
validation study on a new set of at least 300 blinded
prospectively collected blood samples to confirm whether the
sensitivity and specificity of the test remain within commercial
parameters in a CLIA operational setting. Assuming successful
completion of these steps, OncoCyte anticipates launching the
test commercially in the second half of 2017.
Item 9.01 Financial Statements and Exhibits
Exhibit Number
Press Release dated March 6, 2017

About OncoCyte Corporation (NYSEMKT:OCX)

OncoCyte Corporation is a development-stage biotechnology company focused in the field of regenerative medicine. The Company is developing molecular cancer diagnostics utilizing a discovery platform that focuses on identifying genetic markers expressed in various types of cancer. It operates through the research and development of diagnostic tests for the detection of cancer segment. Its initial focus will be confirmatory diagnostics, utilizing liquid biopsy technology, for use in conjunction with imaging to confirm initial diagnoses within certain oncology indications. In addition, it will be developing screening diagnostics as replacements for screening imaging procedures. For some indications, it will also be pursuing the probability of recurrence of a specific cancer through the development of prognostics or companion diagnostics that help a physician determine which therapy is the optimal treatment for the patient. It offers diagnostic tests for lung, breast and bladder cancer.

OncoCyte Corporation (NYSEMKT:OCX) Recent Trading Information

OncoCyte Corporation (NYSEMKT:OCX) closed its last trading session down -0.15 at 5.80 with 11,862 shares trading hands.

An ad to help with our costs