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Meso Scale Technologies LLC., Crescendo Bioscience and Oklahoma Medical Research Foundation | Date: 2016-11-29

Biomarkers useful for diagnosing and assessing inflammatory disease are provided, along with kits for measuring their expression. The invention also provides predictive models, based on the biomarkers, as well as computer systems, and software embodiments of the models for scoring and optionally classifying samples. The biomarkers include at least two biomarkers selected from the DAIMRK group and the score is a disease activity index (DAI).


Patent
Oklahoma Medical Research Foundation and Crescendo Bioscience | Date: 2011-11-07

A method scores a sample, by receiving a first dataset associated with a first sample obtained from a first subject, wherein said first dataset comprises quantitative data for at least two markers selected from the group consisting of: CCL22; CHI3L1; COMP; CRP; CSF1; CXCL10; EGF; ICAM1; ICAM3; ICTP; IL1B; IL2RA; IL6; IL6R; IL8; LEP; MMP1; MMP3; PYD; RETN; SAA1; THBD; TIMP1; TNFRSF11B; TNFRSF1A; TNFSF11; VCAM1; and VEGFA; and determining a first SDI score from said first dataset using an interpretation function, wherein the first SDI score provides a quantitative measure of the rate of change in joint structural damage in said first subject.


Patent
Crescendo Bioscience and Oklahoma Medical Research Foundation | Date: 2010-10-15

Biomarkers useful for diagnosing and assessing inflammatory disease are provided, along with kits for measuring their expression. The invention also provides predictive models, based on the biomarkers, as well as computer systems, and software embodiments of the models for scoring and optionally classifying samples. The biomarkers include at least two biomarkers selected from the DAIMRK group and the score is a disease activity index (DAI).


Patent
Crescendo Bioscience and Oklahoma Medical Research Foundation | Date: 2015-08-21

Biomarkers useful for diagnosing and assessing inflammatory disease are provided, along with kits for measuring their expression. The invention also provides predictive models, based on the biomarkers, as well as computer systems, and software embodiments of the models for scoring and optionally classifying samples. The biomarkers include at least two biomarkers selected from the DAIMRK group and the score is a disease activity index (DAI).


SALT LAKE CITY, Dec. 27, 2016 (GLOBE NEWSWIRE) -- Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced that new data on the use of Vectra® DA test to predict treatment response in patients with rheumatoid arthritis (RA) published online in the journal Arthritis & Rheumatology.1 “This study highlights the clinical utility of the Vectra DA test to help predict treatment response to biologic and non-biologic therapies in methotrexate incomplete responders,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience.  “These results showed that Vectra DA performed better than clinical and single inflammatory biomarkers at predicting response to non-biological therapy intensification versus anti-TNF (infliximab) therapy.  This publication adds to the growing body of data on the use of the Vectra DA test to help individualize treatment plans and improve health outcomes for patients with RA.” The objective of this study was to evaluate whether the Vectra DA score could be used to predict the optimal choice of second-line treatment for 157 patients with RA who were methotrexate (MTX) incomplete responders (MTX-IR).  The findings demonstrated that, in patients with early RA and incomplete response to MTX, the Vectra DA test predicted those who were more likely to respond to treatment with triple therapy versus anti-TNF (infliximab).  Specifically, patients with a lower Vectra DA score at three months following treatment with MTX monotherapy were more likely to respond to triple therapy versus MTX+infliximab (88 percent vs. 18 percent, respectively; p=0.006).  In contrast, patients who had a high Vectra DA score at three months were more likely to respond to anti-TNF therapy (35 percent vs. 58 percent, respectively; p=0.040).  Importantly, the Vectra DA score at three months was a better independent predictor of treatment response at Year 1 than clinical or single inflammatory biomarkers (CRP, ESR) or DAS28). These results demonstrate that Vectra DA could be used to guide biologic or non-biologic treatment decisions for patients with early RA who do not respond to MTX monotherapy in the first three months. The Vectra DA test is the first and only multi-biomarker blood test validated to measure disease activity in patients with RA.  Vectra DA has been evaluated in more than 20 studies with more than 3,000 patients.  The value that Vectra DA offers rheumatologists is demonstrated by the fact that 3 out of 4 rheumatologists have ordered Vectra DA for ~300,000 patients in the United States. Recently, Vectra DA was included in guidelines published by United Rheumatology, and will be evaluated for inclusion in the American College of Rheumatology (ACR) guidelines. 1 Hambardzumyan K, Saevarsdottir S, Forslind K, et al.  A multibiomarker disease activity score and the choice of second-line therapy in early rheumatoid arthritis after methotrexate failure.  Arthritis Rheumatol.  December 19, 2016.  Accessed online at: www.ncbi.nlm.nih.gov/pubmed/27992691. About Vectra® DA Vectra DA is the only multi-biomarker blood test for rheumatoid arthritis (RA) disease activity that integrates the concentrations of 12 serum proteins associated with RA disease activity into a single objective score, on a scale of 1 to 100, to help physicians make more informed treatment decisions. Vectra DA testing is performed at the Crescendo Bioscience state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician 5 to 7 days from shipping of the specimen to Crescendo Bioscience. Physicians can receive test results via standard mail, by fax or via the private web portal, VectraView. For more information on Vectra DA, please visit: www.Vectra-DA.com. About Crescendo Bioscience Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, located in South San Francisco, Calif.  Crescendo Bioscience develops quantitative, objective, reproducible blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases.  For more information, please visit the company website at www.CrescendoBio.com. About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G Safe Harbor Statement This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Vectra DA data published in the journal Arthritis & Rheumatology; the ability of Vectra DA to predict or assess treatment response in patients with rheumatoid arthritis; and the Company’s strategic directives under the captions “About Crescendo Bioscience” and “About Myriad Genetics.”  These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements;  the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual report on Form 10-K for the fiscal year ended June 30, 2016, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.


SALT LAKE CITY, Nov. 12, 2016 (GLOBE NEWSWIRE) -- Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced that four poster presentations on Vectra® DA will be featured at the American College of Rheumatology (ACR) meeting being held Nov. 11-16, 2016 in Washington, D.C.   “Crescendo is pioneering a personalized medicine approach for autoimmune disorders and is committed to helping all patients with rheumatoid arthritis achieve their treatment goals,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience.  “We are excited about the new data being presented at ACR, including data presented by our collaborators that advance the science of Vectra DA. These findings provide additional information for rheumatologists as they optimize the care of their RA patients.” Please plan to visit Crescendo at Booth #323 for more information about Vectra DA.  Abstracts are available online at: http://acrabstracts.org/meetings/2016-acrarhp-annual-meeting/.  Follow Vectra DA on Twitter via @VectraDA and Myriad via @MyriadGenetics to stay informed about news and updates from the Company. This study evaluated the biological variability in Vectra DA scores over a 24-hour period and day-to-day in 28 patients with rheumatoid arthritis (RA) with the goals of determining a minimally important difference (MID) and establishing a cut point for a meaningful change in Vectra DA scores over time.  The results showed that, based on the short-term variability in the Vectra DA score among stable RA patients tested serially over time, the MID in the score was 9 units.  Changes exceeding this threshold are unlikely due to diurnal and daily biological variations alone. Based on these data, blood samples for Vectra DA testing taken during normal office hours (8:00 a.m. to 5:00 p.m.) would not be expected to be impacted by a diurnal variation in the Vectra DA score in clinically stable patients. This study evaluated the utility of Vectra DA in assessing the risk of cardiovascular outcomes and serious infections in a large U.S. Medicare claims database of patients with RA (approximately 17,000 patients with linkable Vectra DA scores).  Researchers examined the relationship between the Vectra DA score and the risk of developing infections requiring hospitalization, myocardial infarction (MI) and a composite coronary heart disease (CHD) outcome, including percutaneous coronary intervention and coronary artery bypass graft. The results showed that high Vectra DA scores were associated with an increased risk for all of these outcomes.  These findings indicate that the use of the Vectra DA score to risk-stratify patients for these serious adverse events may help clinicians identify those at highest risk. This study evaluated the Vectra DA (MBDA) score as a predictor of flare or sustained clinical remission after discontinuation of adalimumab (ADA) in patients with established RA from the HONOR study.  The analysis included 42 patients receiving ADA and methotrexate (MTX) who maintained DAS28-ESR remission (<2.6) for ≥24 weeks and agreed to discontinue their ADA.  Clinical disease activity, functional status and joint damage were recorded at ADA discontinuation (baseline) and after 24 and 52 weeks.  Vectra DA scores were measured at ADA discontinuation, and the ability of Vectra DA to predict flare or remission was assessed at six months and one year. All patients had DAS28-ESR <2.6 at baseline and the median Vectra DA score at baseline was 24.5 with 22 patients in remission, six with low, nine with moderate and five with high Vectra DA scores.  At 52 weeks, the rate of flare and sustained remission by Vectra DA category (remission/low/moderate/high) was 13.6, 50.0, 33.3 and 60.0 percent (p=0.033) and 63.6, 33.3, 33.3, and 0 percent (p=0.0066), respectively.  These findings suggest that the Vectra DA score could predict flare and biologic-free remission in patients in stable remission undergoing ADA withdrawal while maintaining MTX treatment.  The results point to the potential clinical utility of Vectra DA for guiding treatment decisions in patients with RA. The objectives of this study were to evaluate 180 early RA patients from the OPERA trial for associations between the baseline Vectra DA score and 12-month radiographic outcomes, and to assess the value of adding the Vectra DA score to the anti-cyclic citrullinated peptide (anti-CCP) status for predicting radiographic progression (RP).  The results showed that a high baseline Vectra DA score was a strong, independent predictor of RP and it added value to anti-CCP status.  Patients with a high baseline Vectra DA score (>44) were more likely to progress radiographically (31 percent), while only three percent of patients with a score (≤44) progressed (p<0.01).  High versus moderate baseline DAS-CRP was not associated with RP (p=1.0). 34 percent of anti-CCP positive and 12 percent of anti-CCP negative patients had RP (p<0.002); however, none of the anti-CCP positive patients with a Vectra DA score ≤44 progressed radiographically, whereas stratifying by DAS-CRP had no added value to the anti-CCP alone.  These data further support the ability of Vectra DA to predict radiographic progression. About Rheumatoid Arthritis Rheumatoid arthritis is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation of the joints, and in some cases, joint destruction and disability.  An estimated 1.5 million Americans have the condition, which affects nearly three times as many women as men. While the cause of RA is unknown, many cases are believed to result from genetic and environmental factors. About Vectra® DA Vectra DA is the only multi-biomarker blood test for rheumatoid arthritis disease activity that integrates the concentrations of 12 serum proteins associated with RA disease activity into a single objective score, on a scale of 1 to 100, to help physicians make more informed treatment decisions. Vectra DA testing is performed at the Crescendo Bioscience state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician 5 to 7 days from shipping of the specimen to Crescendo Bioscience. Physicians can receive test results via standard mail, by fax or via the private web portal, VectraView. For more information on Vectra DA, please visit: www.Vectra-DA.com. About Crescendo Bioscience Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, located in South San Francisco, Calif.  Crescendo Bioscience develops quantitative, objective, reproducible blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases.  For more information, please visit the company website at www.CrescendoBio.com. About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris and GeneSight are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G Safe Harbor Statement This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Vectra DA data to be presented at the 2016 American College of Rheumatology (ACR) Annual Meeting, Nov. 11-16, 2016 in Washington, D.C.; the potential clinical utility of the Vectra DA study results and findings for guiding treatment decisions in patients with RA;  and the Company’s strategic directives under the captions “About Crescendo Bioscience” and “About Myriad Genetics.”  These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements;  the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual report on Form 10-K for the fiscal year ended June 30, 2016, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.


SALT LAKE CITY, Dec. 22, 2016 (GLOBE NEWSWIRE) -- Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced that United Rheumatology, a leading professional organization for rheumatologists in the United States with more that 300 members, has added Vectra® DA to its clinical practice guidelines for adults with rheumatoid arthritis (RA). The guidelines are designed to assist United Rheumatology healthcare professionals in the diagnosis, treatment and monitoring of patients with RA to preserve function, optimize the achievement of remission or near remission, improve quality of life and monitor outcomes in the safest and most cost-effective fashion possible. “We are very excited that United Rheumatology has recognized the clinical utility of Vectra DA for adults with RA,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience. Vectra DA is the first and only multi-biomarker blood test shown to predict radiographic progression in multiple studies.  The efficacy of Vectra DA has been demonstrated in more than 20 studies with more than 3,000 patients.  The strength of the clinical evidence for Vectra DA has been widely recognized as ~60 percent of practicing rheumatologists have ordered Vectra DA for approximately 300,000 patients in the United States. About Vectra DA Vectra DA is the only multi-biomarker blood test for rheumatoid arthritis disease activity that integrates the concentrations of 12 serum proteins associated with RA disease activity into a single objective score, on a scale of 1 to 100, to help physicians make more informed treatment decisions. Vectra DA testing is performed at the Crescendo Bioscience state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician 5 to 7 days from shipping of the specimen to Crescendo Bioscience. Physicians can receive test results via standard mail, by fax or via the private web portal, VectraView. For more information on Vectra DA, please visit: www.Vectra-DA.com. About Crescendo Bioscience Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, located in South San Francisco, Calif.  Crescendo Bioscience develops quantitative, objective, reproducible blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases.  For more information, please visit the company website at www.CrescendoBio.com. About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris and GeneSight are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G Safe Harbor Statement This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the inclusion of the Vectra DA test in the United Rheumatology clinical practice guidelines for adults with rheumatoid arthritis; the United Rheumatology guidelines providing treatment recommendations to ensure that patients receive diagnostic treatment and services that are likely to improve clinical outcomes; the use of the Vectra DA test to help patients and their physicians better assess their risk of disease activity; the ability of the Vectra DA test to predict radiographic progression;  and the Company’s strategic directives under the captions “About Crescendo Bioscience” and “About Myriad Genetics.”  These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements;  the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual report on Form 10-K for the fiscal year ended June 30, 2016, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.


Biomarkers useful for assessing inflammatory disease or flare activity, in particular in juvenile idiopathic arthritis, are provided, along with kits for measuring expression of the biomarkers. The invention also provides predictive models, based on the biomarkers, as well as computer systems, and software embodiments of the models for scoring and optionally classifying samples.


BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--LEERINK Capital Partners, the asset management affiliate of LEERINK Partners, a leading healthcare investment bank, and Revelation Partners, an investment firm focused on late-stage, private healthcare companies, announced today that they have created an investment platform that provides capital and liquidity to healthcare investors, companies, founders and funds, called LEERINK Revelation Partners. In addition, they announced the close of its first fund, LEERINK Revelation Healthcare Fund I, with $192 million of commitments, surpassing its initial target of $175 million. LEERINK Revelation Partners combines the experience and resources of LEERINK’s leading healthcare investment bank with Revelation Partners’ established leadership in secondary transactions across healthcare. The investing team is based in San Francisco and invests broadly across healthcare sectors, focusing on commercial companies that have proven business models or companies with novel technologies that have clear clinical and regulatory pathways. Specifically, the firm invests in medical devices, diagnostics, biopharmaceuticals, healthcare IT and healthcare services. Recent investments of the Fund include: Crescendo Bioscience, PneumRX, Inc., Corventis and DiscoveRx Corporation. The investment team, led by Scott Halsted, Dr. Zack Scott, and Michael Boggs has been executing this strategy, often referred to as direct secondary investing, for the past seven years. Prior to the partnership with LEERINK, the investment team has invested over $230 million in healthcare secondary transactions. Jeff Leerink, Chairman and CEO of LEERINK Partners, said, "We are very excited by this partnership and look forward to working with Scott and his team. Our unique position and institutional knowledge in the healthcare marketplace will help to strengthen what is already a very impressive team and investment platform, and we are all equally committed to its success.” James Nahirny, Managing Partner of LEERINK Capital Partners said, “We see this as yet another way in which LEERINK can support companies and investors who are shaping the future of healthcare. Revelation Partners’ substantial experience and proven track record in direct secondary investing in late-stage, private healthcare companies makes them an ideal partner for LEERINK, as we are uniquely suited to add value to this highly regarded investment team.” “We believe our investment strategy capitalizes on an attractive market opportunity, given the macro trends affecting traditional healthcare investors and declining number of active venture capital firms,” said Mr. Halsted. “There are many exciting healthcare companies that have taken more time and more money than originally expected to achieve scale and, as a result, there is often misalignment in the investor syndicate relative to the ability or desire to fund the company for an optimal exit. By providing liquidity and financing options to these existing investors, we can help to re-align the investors and maximize the company’s value.” He continued, “Working with LEERINK provides a substantial competitive advantage, and we look forward to leveraging their distinct expertise, broad industry relationships and unrivaled position in healthcare to deliver value to our investors and portfolio companies alike.” LEERINK Partners LLC is a leading investment bank, specializing in healthcare. Our knowledge, experience and focus enable us to help our clients define and achieve their strategic, capital markets and investment objectives. We partner with companies that develop and commercialize innovative products and services that are defining the future of healthcare. LEERINK Partners LLC is a member of FINRA/SIPC. For more information, please visit: www.leerink.com. Revelation Partners is a San Francisco-based investment firm that invests in late-stage, private healthcare companies acquired in negotiated transactions from existing shareholders. We invest broadly across healthcare sectors with a focus on commercial companies with proven business models or companies with novel technologies that have clear clinical and regulatory pathways. We actively invest in the following healthcare verticals - medical devices, biopharmaceuticals, healthcare IT and healthcare services. For more information, please visit: www.revelation-partners.com.


News Article | June 20, 2015
Site: www.inc.com

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