Hartford, CT, United States
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Disclosed herein are compositions and methods relevant to a novel Drug Metabolism Reserve Physiotype to determine the metabolic capacity of a human individual. The Drug Metabolism Reserve Physiotype allows the determination of the innate metabolic capacity of the patient relevant to antidepressant and stimulant treatment and can be predicted and diagnosed simply from a blood sample. In the disclosed method, an individual is genotyped for a plurality of polymorphisms in a gene encoding CYP2C9, a gene encoding CYP2C19 and a gene encoding CYP2D6, and the genotypes are used to produce four novel indices, which relate to the metabolic capacity of the human individual.


News Article | May 24, 2017
Site: www.marketwired.com

WEST PALM BEACH, FL--(Marketwired - May 24, 2017) - Rennova Health, Inc. ( : RNVA) ( : RNVAZ) ("Rennova" or the "Company") reports financial results for the first quarter ended March 31, 2017 and provides a business update. Rennova is a provider of an expanding number of services for healthcare providers and their patients. Historically, we have operated under one management team, but beginning in the first quarter of 2017, the Company began operating four synergistic divisions, each with specialized management. The divisions are: 1) Clinical diagnostics through our clinical laboratories; 2) Supportive software solutions to healthcare providers including Electronic Health Records ("EHR"), Laboratory Information Systems and Medical Billing services; 3) Decision support and interpretation of cancer and genomic diagnostics (Advanced Molecular Services ("AMS") Group, Inc.); and 4) the recent addition of a hospital in Tennessee. We believe our approach will produce a more sustainable relationship and the capture of multiple revenue streams from the provision of needed services and solutions to medical providers. Historically, we have specialized in providing urine and blood drug toxicology and pain medication testing to physicians, clinics and rehabilitation facilities in the United States. We intend to expand our business operations in each sector in which we focus and will continue to assess the best way to do so. We may consider the sale of or spin-off of one or more of our business operations if deemed to be the best way to create value for our stockholders. Significant highlights from the first quarter of 2017 and recent weeks include: "Our financial results were largely as anticipated during the first quarter, and we are pleased to have narrowed our operating loss by 32%. In addition, the measures we have taken to reduce cost of goods by consolidating laboratories and lowering headcount have led to continued improvement in gross margins. Importantly, direct costs per sample decreased to $34.41 this quarter from $73.75 a year ago. Substantial non-cash interest expenses clouded our progress in the first quarter, but we continue to expect to report positive cash flow from operations before the year is out," said Seamus Lagan, Rennova's chief executive officer. "We have had further success with signing new customers, in particular adding preferred provider networks, forging contracts with third-party payers, adding Medicaid contracts and increasing the number of tests we offer in our clinical laboratory segment," he added. "We are looking forward to opening our Big South Fork Medical Center in Tennessee. We hoped the Center would be open before the end of the second quarter, but the licensure and inspections required mean it is more likely it will reopen early in the third quarter. The assets of this rural hospital were purchased for $1.0 million during January, having generated $12 million in revenues in 2015, the last full year it was in operation. We believe this facility will provide us with a reliable customer base and important preferred provider contracts to assure payment for services provided. It also allows us to solidify relationships with local physicians for all our offerings. "As previously announced, in recent weeks we formed Advanced Molecular Services Group to focus on precision medicine. The Group includes CollabRx, Genomas and Alethea Laboratories. Subject to required consents and approvals, we may spin this group off to our stockholders in order to create additional value, and we are actively considering this option. The growing demand for precision medicine-based tests both on the market and being developed by this Group bodes well for the appeal of a spin-off," Mr. Lagan concluded. Net revenues for the first quarter of 2017 were $1.2 million, compared with $1.9 million for the first quarter of 2016. The decrease is mainly the result of a 64% decline in insured test volumes in the Company's Clinical Laboratory Operations business segment. Net revenues in each of the Company's Supportive Software Solutions and Decision Support and Informatics segments were essentially unchanged at $0.2 million for the first quarter of 2017 and 2016. In addition, the collectible portion of gross billings that was reflected in net revenues was 13% of outgoing billings determined as of March 31, 2017, compared with 17% as of March 31, 2016. Operating expenses for the first quarter of 2017 were $5.8 million, compared with $8.6 million for the first quarter of 2016. The reduction was primarily due to a decline of $0.3 million in direct costs of revenue, a decline of $2.2 million in general and administrative expenses, a decline of $0.6 million in sales and marketing expenses, a decline of $0.1 million in engineering expenses and a decline of $0.1 million in depreciation and amortization, partially offset by $0.5 million in operating expenses related to Big South Fork Medical Center. The Company has transitioned a significant portion of its testing from external reference laboratories to internal processing, which resulted in a 53% decrease in direct costs per sample. The Company's loss from operations for the first quarter of 2017 was $4.6 million, compared with $6.8 million for the first quarter of 2016. The narrowing of operating loss was mainly due to expense reductions, partially offset by lower net revenues. Net loss attributable to common stockholders for the first quarter of 2017 was $49.7 million, or $10.15 per share, compared with net loss attributable to common stockholders for the first quarter of 2016 of $4.2 million, or $8.59 per share. The increase was largely attributed to interest expense of $45.6 million, which includes a $44.1 million non-cash interest charge mainly related to the issuance of convertible debentures and warrants during the period and an additional $0.9 million for the amortization of debt discount and deferred financing costs, compared with $1.0 million in interest expense in the prior-year's first quarter. The Company had cash and cash equivalents of $1.4 million as of March 31, 2017, compared with $77,979 as of December 31, 2016. Rennova provides industry-leading diagnostics and supportive software solutions to healthcare providers, delivering an efficient, effective patient experience and superior clinical outcomes. Through an ever-expanding group of strategic brands that work in unison to empower customers, we are creating the next generation of healthcare. For more information, please visit www.rennovahealth.com. This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Actual results may differ from expectations and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Additional information concerning these and other risk factors are contained in the Company's most recent filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.


Combines Three Subsidiaries to Provide Advanced Precision Medicine for Patients, Physicians and Health Organizations; Appoints Industry Veteran Scott Jenkins to Lead the Group WEST PALM BEACH, FL--(Marketwired - May 04, 2017) - Rennova Health, Inc. ( : RNVA), ( : RNVAZ) ("Rennova" or the "Company"), a vertically integrated provider of industry-leading diagnostics and supportive software solutions to healthcare providers, announces the formation of the Advanced Molecular Services Group, Inc. ("AMS Group" or the "Group") to focus on precision medicine. The Group includes CollabRx, Inc., Genomas, Inc. and Alethea Laboratories, Inc., Rennova's New Mexico laboratory. Rennova's board of directors is considering all options to create shareholder value, and subject to required consents and approvals may spin off the Group to its stockholders. AMS Group's focus will be on mental and behavioral health, oncology, urology and cardiovascular disease. These areas benefit from understanding each person's molecular profile and, in turn, determining the best treatment protocol. The Group's proprietary technology combines Rennova's advanced testing development whereby the results of laboratory data are interpreted to provide treatment guidance to physicians and patients, with expertise in machine learning. Over time the AMS Group is expected to expand its offerings in both areas to help deliver precision medicine-based solutions. Rennova has licensed a critical mobile application that brings these services to users and intends to release a beta version this summer. This would bring the AMS Group's advanced products to patients, physicians and health organizations throughout the U.S. with testing to be conducted at Alethea Laboratories. Rennova also announces that following an extensive search, Scott Jenkins, Ph.D., a long-time Silicon Valley Healthcare IT executive with nearly 30 years of experience, has been selected to lead the newly formed AMS Group as chief executive officer. Dr. Jenkins is responsible for the integration of the operations of the individual companies that comprise the Group. "Precision medicine is exploding in part because of advances in diagnostic technologies and machine learning. Rennova has these key components to be a leader in this space," says Dr. Jenkins. "Every patient, physician and health organization needs immediate access to these life-changing tools, and we are going to deliver them." Dr. Jenkins comes to Rennova from Alchemist Ventures, where he led the development of many innovative precision medicine companies. Dr. Jenkins has been an executive in Healthcare and Life Sciences at Applied Biosystems, IBM and Apple, and more recently at Dell Healthcare where he was Vice President for Healthcare Solutions sales. Over the past several years, Dr. Jenkins has been committed to the advancement of precision medicine. He has lectured and presented papers at many global conferences, including most recently at Health2.0, The Milken institute, Best Practices in Personalized Medicine, The Galan Institute and Personalized Medicine World. He holds a Ph.D. in organic chemistry from the University of Minnesota and a B.S. in chemistry from Minnesota State University. Rennova provides industry-leading diagnostics and supportive software solutions to healthcare providers, delivering an efficient, effective patient experience and superior clinical outcomes. Through an ever-expanding group of strategic brands that work in unison to empower customers, we are creating the next generation of healthcare. For more information, please visit www.rennovahealth.com. This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Actual results may differ from expectations and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Additional information concerning these and other risk factors are contained in the Company's most recent filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.


Seip R.L.,Genomas Inc. | Seip R.L.,Hartford Hospital | Duconge J.,University of Puerto Rico at San Juan | Ruano G.,Genomas Inc. | Ruano G.,Hartford Hospital
Future Cardiology | Year: 2010

Genotyping has the potential to improve the efficacy and safety of major antithrombotic drugs. For warfarin, the stable maintenance dose varies from 1-10 mg/day. The VKORC1 -1639G>A allele and the CYP2C9*2 and *3 alleles (cumulative frequency: 90% in Asians, 65% in Europeans and 20% in Africans), explain 45% of response variability in European and 30% in African populations. The large clinical trials COAG and EU-PACT will define the extent to which pharmacogenetic dosing affects the safety and efficacy of warfarin and coumarin derivatives. The platelet inhibitor clopidogrel requires activation by the CYP2C19 enzyme. CYP2C19*2 and *3 alleles (cumulative frequency: 20-50%) produce null enzyme activity, and their presence attenuates platelet inhibition and increases cardiovascular events. The US FDA-mandated drug labeling recognizes the relevance of genotyping in the selection and dosing of both warfarin and clopidogrel. © 2010 Future Medicine Ltd.


Ruano G.,Hartford Hospital | Ruano G.,Genomas Inc. | Szarek B.L.,Hartford Hospital | Villagra D.,Genomas Inc. | And 5 more authors.
Biomarkers in Medicine | Year: 2013

Aim: This study aimed to determine the effect of the CYP2D6 genotype on the length of hospitalization stay for patients treated for major depressive disorder. Methods: A total of 149 inpatients with a diagnosis of major depressive disorder at the Institute of Living, Hartford Hospital (CT, USA), were genotyped to detect altered alleles in the CYP2D6 gene. Prospectively defined drug metabolism indices (metabolic reserve, metabolic alteration and allele alteration) were determined quantitatively and assessed for their relationship to length of hospitalization stay. Results: Hospital stay was significantly longer in deficient CYP2D6 metabolizers (metabolic reserve <2) compared with functional or suprafunctional metabolizers (metabolic reserve ≥2; 7.8 vs 5.7 days, respectively; p = 0.002). Conclusion: CYP2D6 enzymatic functional status significantly affected length of hospital stay, perhaps due to reduced efficacy or increased side effects of the medications metabolized by the CYP2D6 isoenzyme. Functional scoring of CYP2D6 alleles may have a substantial impact on the quality of care, patient satisfaction and the economics of psychiatric treatment. © 2013 Future Medicine Ltd.


The invention is generally directed to a physiogenomic method for predicting diabetes and metabolic syndromes induced by psychotropic drugs. In one embodiment, the invention relates to the use of genetic variants of marker genes to predict the likelihood that an individual will experience undesirable metabolic side effects as a result of the use of a drug including, but not limited to, psychotropic drugs. The invention also relates to methods predicting the likelihood of diabetes and metabolic syndromes induced by the use of drugs with undesirable metabolic side effects.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.25M | Year: 2011

DESCRIPTION (provided by applicant): Currently 30 million Americans with elevated cholesterol receive statin therapy, making statins the most prescribed drug class in the U.S. Statin Induction and Neuro-Myopathy (SINM), the balance of potency and safety, is the main clinical management challenge of these drugs, particularly when treatment targets are aggressive requiring LDL cholesterol levels below 100 mg/dl. In medical practice, Neuro-Myopathy presents as a constellation of neuromuscular side effects, including myalgia (muscle aches, cramps, weakness) and myopathy (muscular injury monitored by serum creatine kinase (CK) elevation). Neuro-myopathy is more frequent at the higher doses required for treating advanced cardiovascular disease and varies in extentbetween individual statins and from patient to patient. Statin usage is ultimately limited by toxicity. Clearly there is an urgent need to simultaneously avert side effects and optimize lipid lowering at the outset of treatment to bolster success in lowering cardiovascular disease risk in literally millions of patients. Recognizing that clinicians balance safety with efficacy when prescribing statins, our research group and others have established genetic markers that are valid candidates for a panel of safety and efficacy markers. The SINM PhyzioType System is the first diagnostic tool to integrate statin safety and efficacy markers for clinical use. The SINM PhyzioType system can predict the safety and efficacy of the pre-eminent statin drugs (namely, atorvastatin [Lipitor(R)], simvastatin [Zocor(R)], and rosuvastatin [Crestor(R)]-which together account for 85% of the U.S. market share8) according to the genome of each patient, enabling selection of the optimal drug for each patient. Alternatively if a patient's genomic profile proves to be incompatible with statins, the clinician can opt to prescribe another drug class. This Phase II Renewal Program is entitled SYSTEM FOR DNA-GUIDED OPTIMIZATION AND PERSONALIZATION OF STATIN THERAPY. Our previous Fast-Track SBIR Program enabled the discovery of gene markers and configuration of predictive bioclinical algorithms, and it advanced the clinical development of the SINM PhyzioType product closer to commercialization. The proposed Phase II Renewal Program will validate the performance of the SINM PhyzioType product in a prospective study of an independent population of 400 patients naove to statin therapy or who had not received statins for at least 3 months. Allocated funds will be used to validate the product forpersonalized clinical management of statins, to develop a medical informatics interface enabling use of the product by clinicians (Personalized Health Portal) and to prepare the SINM PhyzioType for commercialization. With this project, Genomas will continue to enlist some of the most highly qualified lipid clinical specialists in the world, including Paul D. Thompson, M.D., of Hartford Hospital's Division of Cardiology, John P. Kane, M.D., of the Cardiovascular Research Institute at University of California at San Francisco, and Bruce Gordon, M.D., of the Rogosin Institute at New York Presbyterian Medical Center for this Program. Theodore Holford, Ph.D., of the Yale School of Medicine will serve as a consultant in biostatistics. The expected outcome is final development of the Genomas product SINM PhyzioTypeTM System, that predicts the variable lipid-altering efficacy and the risk of drug-induced neuromuscular side effects that arise in the substantial segment of patients receiving statins. With data collected Phase II Renewal funding, Genomas will be able to serve confirmatory proof that the PhyzioType product is a reliable, reproducible and cost-effective product enabling physicians to optimize treatment strategies in lipid disorders while avoiding neuromyopathy. The goal is to enable clinicians to deploy a genetic decision support system to manage statins, prescribe these drugs on a DNA-guided, personalized basis and effectively lower the risk of cardiovascular disease for each patient. PUBLIC HEALTHRELEVANCE: In the proposed Phase II Renewal Program, the SINM PhyzioTypeTM System for optimization and personalization of statin therapy will be validated through a prospective study to finalize the product ahead of commercialization. This validation study will serve confirmatory proof that the SINM PhyzioTypeTM System is a reliable, reproducible and cost-effect product enabling physicians to optimize treatment strategies in lipid disorders and minimize detrimental neuromuscular side effects. This pioneering product, which represents the first tool to integrate statin safety and efficacy markers for clinical use, will advance the practice of personalized medicine and reduce side effects while elevating therapeutic benefits of the country's most popular drugs that are already on the market.


The present invention relates to the use of genetic variants of associated marker genes to predict an individuals susceptibility to muscular injury and muscular side effects in response to statin therapy. The present invention further relates to analytical assays and computational methods using the novel marker gene set. The present invention has utility for personalized medical treatment, drug safety, statin compliance, and prophylaxis of muscle side effect.


Disclosed herein are compositions and methods relevant to a novel Drug Metabolism Reserve Physiotype to determine the metabolic capacity of a human individual. The Drug Metabolism Reserve Physiotype allows the determination of the innate metabolic capacity of the patient relevant to antidepressant and stimulant treatment and can be predicted and diagnosed simply from a blood sample. In the disclosed method, an individual is genotyped for a plurality of polymorphisms in a gene encoding CYP2C9, a gene encoding CYP2C19 and a gene encoding CYP2D6, and the genotypes are used to produce four novel indices, which relate to the metabolic capacity of the human individual.


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