August 2, 2017 | July featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including CombiMatrix, HudsonAlpha, MDxHealth, and more.
CombiMatrix announced that it has entered into a definitive merger agreement with Invitae to be acquired in an all-stock merger for approximately $33 million of combined consideration, based on a fixed price per share of Invitae’s common stock of $9.49, and subject to certain adjustments described below. The merger has been approved by each company’s board of directors and is conditioned upon, among other things, approval by CombiMatrix’s stockholders, Invitae’s registration of common stock to be used to acquire CombiMatrix, and at least 90% participation in a warrant exchange offer as noted below. CombiMatrix engaged in a fifteen-month long market check with the assistance of its exclusive financial advisor. After the conclusion of that market check, CombiMatrix, assisted by its advisors, had months of negotiations with Invitae before entering into the definitive merger agreement. The consideration payable to the holders of currently outstanding shares of CombiMatrix common stock, as well as currently outstanding Series F preferred stock, restricted stock units and in-the-money options, is $27 million, based on a fixed price per share of Invitae’s common stock of $9.49 and subject to an adjustment for “Net Cash” of CombiMatrix at closing. Net Cash, as defined in the merger agreement for this purpose, includes all current assets, less all current liabilities (including amounts payable pursuant to the Company’s executive severance plan) and capital lease obligations of the Company, less all transaction-related expenses including amounts owed to the Company’s strategic advisors, accountants and attorneys, less amounts owed to repurchase certain CombiMatrix common stock warrants, less amounts payable under the Company’s transaction bonus plan that was adopted on December 2, 2015 and less $250,000 stipulated for working capital purposes. Based on the Company’s current forecasts and estimates of Net Cash, and based on a fixed price per share of Invitae’s common stock of $9.49, the Company presently estimates that the CombiMatrix price per share received by CombiMatrix common stockholders would be between approximately $8.00 and $8.65. Because the value of the transaction to CombiMatrix stockholders is based on a fixed price per share of Invitae’s common stock of $9.49, the overall value of the merger consideration potentially to be received by CombiMatrix stockholders will fluctuate based on the market price of Invitae common stock between now and any closing. There are currently 2,918,726 shares of CombiMatrix common stock outstanding, and an additional 125,738 shares of CombiMatrix common stock issuable pursuant to currently outstanding Series F preferred stock, restricted stock units and in-the-money common stock options. As part of the proposed acquisition, the merger agreement contemplates that Invitae will conduct an exchange offer in which holders of CombiMatrix Series F warrants will be offered approximately $6 million in shares of Invitae common stock, based on $2.90 per warrant and 2,067,076 Series F warrants currently outstanding, with such consideration also based on a fixed price per share of Invitae’s common stock of $9.49. Because the value of the transaction is based on a fixed price per share of Invitae’s common stock of $9.49, the overall value of the exchange offer consideration potentially to be received by CombiMatrix Series F warrant holders will fluctuate based on the market price of Invitae common stock between now and any closing. Under the terms of the merger agreement, holders of at least 90% of the Series F warrants outstanding must accept the exchange tender offer and tender their warrants to receive shares of Invitae common stock. If holders of less than 90% of outstanding Series F warrants tender, Invitae may elect to terminate the merger. Holders of Series F Warrants may exercise their warrants at any time prior to any closing of the merger if they so choose, and the merger agreement anticipates an increase in the consideration paid to CombiMatrix common stockholders as more shares of CombiMatrix common stock become outstanding as a result of such exercises. Based on a fixed price per share of Invitae’s common stock of $9.49 and subject to the Net Cash adjustment, the consideration potentially to be received by CombiMatrix common stockholders (including holders of shares issued upon the exercise of Series F warrants) could increase by approximately $15 million, if all Series F Warrants were exercised. The proposed merger is expected to close in the fourth quarter of 2017, but is subject to customary closing conditions, including CombiMatrix stockholder approval, as well as the warrant exchange participation threshold noted above. Press release
Kailos Genetics announced a strategic partnership with and investment from In-Q-Tel (IQT). IQT is the non-profit strategic investor that identifies and accelerates the development of innovative technologies to support the mission of the U.S. Intelligence Community. This strategic partnership and investment allows Kailos to continue the development of NGS laboratory and software solutions that may benefit the intelligence community. Press release
Full scale recruitment for the Alabama Genomic Health Initiative (AGHI) has begun at University of Alabama at Birmingham clinics in Birmingham. The AGHI is one of the nation’s first statewide efforts to harness the power of genomic analysis to identify those at high risk for genetic disease. The AGHI, a partnership between UAB and HudsonAlpha Institute for Biotechnology, was announced on March 9. It will recruit a diverse group of participants from every county in Alabama and provide genomic analysis and interpretation to this group free of charge. Following the conclusion in May of a pilot project that recruited the first 100 participants, the AGHI has now opened widespread recruitment with the intent of adding 2,000 individuals in the first year. Over a five-year period, the goal will be to increase the number of participants to more than 10,000 persons. “This project will result in immediate health benefits to some participants, and in the long term will help to address problems of chronic disease and rising health care costs in the state,” said Bruce Korf, chair of the UAB Department of Genetics and co-director of the AGHI, in a press release. “It will also position Alabama as a leader at the forefront of 21st century medicine.” Press release
MDxHealth announced the commercial launch of its AssureMDx for Bladder Cancer test in the United States as a laboratory developed test (LDT). Testing will be conducted at the Company’s state-of-the-art CAP and CLIA accredited laboratory facilities in Irvine, California. Each year in the United States, it is estimated that nearly 11 million patients are referred to a urologist for clinical evaluation due to hematuria (blood in urine). Hematuria is the most common symptom of bladder cancer, yet only 3% to 28% of hematuria patients are diagnosed with bladder cancer. The current standard of care for bladder cancer diagnosis is a cystoscopy, which is an invasive procedure where a cystoscope is inserted into the patient’s urethra to visualize the bladder wall and to perform a biopsy if a lesion is identified. However, given the low prevalence of bladder cancer, the vast majority of hematuria patients could avoid the unnecessary discomfort and cost of cystoscopy, if cancer could be ruled out by a less intrusive method. AssureMDx is a non-invasive, urine-based test, combining methylation and mutation biomarkers, to assess the risk of bladder cancer for patients diagnosed with hematuria. AssureMDx has been validated to improve upon the standard of care, helping rule out the risk of bladder cancer with a negative predictive value (NPV) of 99%.2 The high NPV led study investigators to report that the test could potentially spare as many as 77% of hematuria patients from undergoing a cystoscopy. Furthermore, the test’s 93% sensitivity and 85% specificity can help doctors identify patients at increased risk for bladder cancer, who may benefit from cystoscopy. Press release
Definiens announced the strengthening of its leadership team. To support the company’s strategic expansion Definiens appointed Heinz Oehl as VP of Global Marketing & Corporate Business Development. In addition, Michael Rasche, formerly Global Head of Sales and Business Development, has been promoted to Chief Commercial Officer (CCO). Heinz Oehl is an MD with more than 15 years of experience in the healthcare and life science industries. He has held various executive positions in the fields of in-vitro diagnostics, laboratory and medical devices and has defined and executed innovative go-to market strategies in international markets. His onboarding further strengthens Definiens’ leadership in providing transformative services to Biopharma enterprises through a service-centric business approach. Definiens provides trusted advice for pre-clinical and clinical pipeline decisions, based on its unprecedented team of leading experts, its unique tissue knowledge base and its unparalleled Tissue Phenomics technology. With Michael Rasche’s leadership Definiens has experienced significant business growth in oncology and immuno-oncology partnerships with the most relevant I/O Pharma and Biotech companies. The Definiens global commercial team lead by Michael as Chief Commercial Officer strives to further strengthen its role as a trusted service partner in immuno-oncology with more patients benefitting from earlier and broader adoption of personalized medicine. Definiens’ innovative services already help to generate actionable biological insights that facilitate the translation of knowledge into novel therapies and treatment strategies, and to de-risk clinical pipelines of I/O Pharma and Biotech companies. Press release
SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, announced the launch of the first fully integrated LC-MS system for clinical diagnostics, the SCIEX Topaz System. The Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS and making it accessible to the entire clinical lab staff. The heart of the system lies within the innovative ClearCore MD software, a platform which simplifies and streamlines workflows and method development and incorporates features that enhance usability to help new users build proficiency quickly. In addition, the first FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the SCIEX Vitamin D 200M Assay, is for use on the SCIEX Topaz System. According to the CDC, LC-MS technology is the gold standard method for testing Vitamin D, as it offers greater specificity and less cross-reactivity over immunoassay methods. The Vitamin D 200M Assay Kit has successfully met the rigorous performance criteria established by the CDC’s Vitamin D Standardization-Certification Program (VDSCP). The assay individually quantitates both Vitamin D2 and D3 while also separating out the D3 epimer, providing the specificity to deliver an accurate measurement of Vitamin D status. Press release