MELBOURNE, AUSTRALIA--(Marketwired - Oct 31, 2013) - -- Genetic Technologies Limited (
- Record number of BREVAGen™ samples received continue to demonstrate encouraging market traction
- New York state approval announced August 30, 2013; BREVAGen now approved in all 50 U.S. states
- Additional agreements executed with top PPOs, with eight contracts signed to-date, totaling 102 million covered lives
- New reimbursement environment has increased average claims received in the quarter
- $6.5M cash raise completed August 1, 2013
Genetic Technologies Limited (
Of particular note during the period, the Company reported a record quarter of test samples received for BREVAGen™, its flagship non-familial breast cancer risk assessment test. The first fiscal quarter of 2014 delivered 914 samples for testing, representing an increase of 52% over the number received for the previous three month period, demonstrating increasing traction in the market. Since launching the BREVAGen test in the U.S. market in June of 2011, Genetic Technologies has reported an increasing number of test samples received in each of the subsequent nine quarters. Encouragingly, test samples received continue to come from a broad mix of U.S. geographical sales territories, illustrating growing acceptance for the test across the wider market. Total revenue for BREVAGen recorded in the first quarter was up 54% sequentially, driven by both increased test samples and favourable reimbursement.
The receipt of "Out of State Licensure" for the key state of New York on August 30, 2013 was a milestone achievement, enabling access to a densely populated demographic of 20 million people. The Company has reported that its U.S. subsidiary, Phenogen Sciences Inc., has deployed its first dedicated sales rep to cover New York, with a particular emphasis on New York City. Following New York state approval, BREVAGen™ is now approved for sale in all 50 U.S. states.
January 1, 2013, marked a material change in the U.S. reimbursement environment for molecular diagnostics, resulting in the removal of the CPT code stack system for insurance claims. Despite this change, the Company continued to execute on contracts with leading U.S. PPOs with an additional key contract with InterWest Health signed during the quarter. To-date, Genetic Technologies has executed eight total agreements with leading U.S. PPOs, representing a cumulative 102 million covered lives for which BREVAGen can be adjudicated. Reimbursement under the new Miscellaneous Code requirement has been encouraging, with the average total payment received from closed cases during the past nine months, including all write-offs and an increased number of denials for non-coverage, increasing significantly. Credentialing contracts have now been executed between the Company and InterWest Health, FedMed Inc., MultiPlan Network, Three Rivers Provider Network, Prime Health Services, National PreferredProvider Network / PlanCare America / Ohio Preferred Provider Network LLC (NPPN / OPPN), Galaxy Health Network and Fortified Provider Network.
"We are very pleased with the continued traction we have demonstrated for our flagship BREVAGen test in the quarter," said Tom Howitt, acting Chief Executive Officer of Genetic Technologies. "With New York state approval finally in hand and our first dedicated sales person in place in the key region, we expect to see increasing uptake for BREVAGen over the coming quarters. We continue to make progress with the top PPOs, and we are pleased to see the January changes to the reimbursement requirements to have had a favorable impact on our topline performance."
Genetic Technologies is now actively involved in a research program with leading international academic collaborators to confirm the utility of genomic risk assessment in other ethnic populations and to incorporate the full portfolio of currently known common breast cancer susceptibility variants into the BREVAGen test. Validation of the expanded test is expected to be completed in early in calendar 2014, with validation of the test for other ethnic populations expected to be completed in the first half of the 2014 calendar year. New versions of the BREVAGen test will subsequently be launched and offered in the U.S. market.
On the licensing front, during the September quarter, Genetic Technologies settled agreements with Genesis Genetics Institute LLC and Genelex Corporation. Discussions with potential new licensees in Europe are ongoing.
As mentioned subsequent to the end of the 2013 financial year, on August 1, 2013, the Company has raised a total of $6,500,000 via the issue of 90,277,778 ordinary shares at an issue price of $0.072 per share through Ladenburg Thalmann. Further, the Company has received a written commitment from one of the Underwriters of the Company's Share Purchase Plan to subscribe for a further 6,944,444 shares at the same issue price of $0.072 per share to raise a further $500,000, before the payment of associated costs. It is anticipated that these further funds will be received shortly.
On September 10, 2013, the Company announced that it had executed documents with Ironridge BioPharma Co., a division of institutional investor Ironridge Global IV, Ltd., in respect of redeemable convertible notes to raise USD 5,000,000 (the "Notes"). The details of the proposed Notes were provided to all shareholders in a Notice of Extraordinary General Meeting ("EGM"), seeking approval from those shareholders for the issue of the Notes, that was released to the ASX on September 19, 2013.
As of October 15, 2013, the Company announced that Alison Mew stepped aside from her day-to-day responsibilities as CEO for a period of three months for personal, health-related reasons. During that period, Thomas Howitt has assumed the role of Acting CEO in addition to his usual roles of CFO and Company Secretary.
On September 11, 2013, the Company granted a total of 1,250,000 options over ordinary shares. The options, which were granted at no cost, entitle the holders to acquire one ordinary share at a price of $0.105 at any time up to, and including July 18, 2018, subject to certain vesting conditions.
The BREVAGen™ breast cancer risk stratification test is a novel genetic test panel that examines a patient's DNA to detect the absence or presence of certain common genetic variations (SNPs) associated with an increased risk for developing breast cancer. The test is designed to help physicians assess aggregate breast cancer risk from these genetic markers, plus factors from a standard clinical assessment based on a patient's family and personal history, thus giving a clearer picture of an individual woman's risk of developing breast cancer. The BREVAGen™ test may be especially useful for women predisposed to hormone dependant breast cancer, including those who have undergone breast biopsies, as the test will provide information that can help physicians recommend alternative courses of action, such as more vigilant, targeted surveillance or preventive therapy, on a personalized patient-by-patient basis.
About Genetic Technologies Limited
Genetic Technologies was an early pioneer in recognizing important new applications for "non-coding" DNA (Deoxyribonucleic Acid). The Company has since been granted patents in 24 countries around the world, securing intellectual property rights for particular uses of non-coding DNA in genetic analysis and gene mapping across all genes in all species. Its business strategy is the global commercialization of its patents through an active out-licensing program and the global expansion of its oncology and cancer management diagnostics portfolio. Genetic Technologies is an ASX and NASDAQ listed company with operations in the USA and Australia. For more information, please visit www.gtglabs.com.
Safe Harbor Statement
Any statements in this press release that relate to the Company's expectations are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act. The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Since this information may involve risks and uncertainties and are subject to change at any time, the Company's actual results may differ materially from expected results. Additional risks associated with Genetic Technologies' business can be found in its periodic filings with the SEC.