On November 4, 2019 Paragon Genomics, Inc., a leader in amplicon-based target enrichment solutions for next-generation sequencing (NGS), reported the upcoming introduction of two new products at the 2019 Association for Molecular Pathology (AMP) Annual Meeting & Expo—a CleanPlex CFTR Panel for cystic fibrosis and CleanPlex Fusion Detection Methods for the diagnostic and prognostic assessment of cancer tumor progression (Press release, Paragon Genomics, NOV 4, 2019, View Source [SID1234550256]).

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The CFTR Panel leverages Paragon Genomics’ CleanPlex technology in a multiplex PCR-based targeted resequencing assay designed to simplify the evaluation of somatic and germline variants across the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. Mutations in this gene cause the devastating disease cystic fibrosis, and more than 1700 mutations have been identified to date. Different mutations affect functioning of the CFTR gene in different ways, so a comprehensive assessment is essential for determining optimal treatment. The CleanPlex CFTR Panel covers all exons of the CFTR gene and includes the important American College of Medical Genetics (ACMG)-recommended mutations, in a rapid and easy-to-use format.

Paragon Genomics also announced early access to its CleanPlex Fusion Detection Methods for known and novel gene fusions. At present, scientists have identified more than 21,000 gene fusions in almost all main subtypes of human cancers. Fusion genes, which often are oncogenes, contribute to tumor formation. The identification of fusion genes can serve as diagnostic and prognostic markers of tumor progression. The CleanPlex Fusion Detection Methods are built upon Paragon Genomics’ key ultra-high multiplex PCR and PCR background cleaning technologies, enabling the detection of fusion genes with or without known breakpoints in a rapid and easy-to-use format. Early access to the first panel, a Lung Cancer Fusion Panel, is now open, and the company will start to provide additional panel products along with a custom fusion assay design service towards the end of this year.

Paragon Genomics is sponsoring a Corporate Workshop at AMP 2019, Precision Medicine Powered by a Rapid, Flexible, and Scalable Target Enrichment Technology, on November 6 from 12:00-12:50 pm in Room 318-320 at the Baltimore Convention Center. Presentations by internal and external scientists will include discussions of the ultra-high multiplexed, rapid CleanPlex TMB panel; a CleanPlex custom 180-gene pharmacogenomics NGS panel; and CleanPlex-powered targeted sequencing of single circulating tumor cells for liquid biopsy applications retrieved using the RareCyte platform. Click here to register.

Paragon Genomics researchers are presenting a poster1 at AMP 2019 demonstrating the utility of its CleanPlex TMB Panel, an ultra-high multiplexed amplicon based NGS target enrichment approach for accurate, rapid and comprehensive TMB profiling, covering all the exons of 500 genes in a robust assay. Additionally, Paragon Genomics’ collaborator, RareCyte, is presenting a poster2 showing how the CleanPlex technology facilitates targeted sequencing of single circulating cancer cells retrieved using the RareCyte platform for liquid biopsy applications.

Tao Chen, CEO of Paragon Genomics, commented, "It’s gratifying to participate in a major industry event like AMP 2019 with important new products for our growing customer base. Our CleanPlex technology has the potential to make NGS-based genomic analyses across a wide variety of applications faster, easier, more accurate, more economical and more feasible. We look forward to sharing our latest advances with customers and colleagues in the coming days."

Paragon Genomics’ CleanPlex is a proprietary, ultra-high multiplexed NGS target enrichment technology featuring an innovative PCR background cleaning chemistry that allows tens of thousands of amplicons to be multiplexed in a single reaction pool, allowing a large number of targets to be interrogated in a single assay. The CleanPlex technology is available as ready-to-use panels or as customized assays designed and optimized using the company’s advanced panel design algorithm. For more information, contact [email protected].

1 – AMP Poster Program #ST061: Assessment of Tumor Mutational Burden Using a Rapid, Amplicon-Based NGS Target Enrichment Strategy for Accurate and Comprehensive Tumor Profiling, Exhibit Hall, Nov. 9, 2019, Session: Solid Tumors, 9:45–10:45 am.

2 – AMP Poster Program #1009: Amplicon-based Targeted Sequencing of Single Circulating Tumor Cell, Exhibit Hall, Nov. 9, 2019, Session: Informatics, 9:45–10:45 am. Presented by RareCyte, Inc.

Paragon Genomics’ CleanPlex products are for Research Use Only.

On November 4, 2019 Laboratory for Advanced Medicine, an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, reported the appointment of Kenneth Chahine, Ph.D., J.D., as Chief Executive Officer and board member (Press release, Laboratory for Advanced Medicine, NOV 4, 2019, View Source [SID1234550255]). He will succeed Founder Shu Li, Ph.D., who will continue to serve as Chairman of the company’s Board of Directors.

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"Dr. Chahine brings a unique combination of experience to the company. He has built, commercialized and scaled one of the largest consumer genomic business in the world, as well as operated in highly regulated therapeutic and diagnostic environments," said Shu Li, Ph.D., Chairman of Laboratory for Advanced Medicine. "Ken will drive the global commercialization of our liquid biopsy pipeline of products to detect liver, colon and breast cancer at early stages and unlock the full potential of the company’s AI-driven cfDNA methylation technology platform. We warmly welcome Ken to the team."

As Executive Vice President and GM of AncestryDNA, Ken created the vision and launched AncestryDNA in 2012 that has grown to become the leading direct-to-consumer genetic genealogy product in the market with over 15 million users. Most recently he led the launch of AncestryHealth, a physician-order LDT product that reports on genetic predisposition to conditions such as breast, ovarian and colon cancer, as well as cardiac and blood clotting disorders on an NGS platform. Prior to Ancestry, he was the Chief Executive Officer at Avigen, where he led the company to develop and commercialize innovative gene therapeutics. Dr. Chahine is on the faculty at the University of Utah’s College of Law and currently teaches a course in new venture development, intellectual property and licensing.

"I am excited to lead a mission-driven company that will bring about a global paradigm shift in early cancer detection and make a profound social impact. Laboratory for Advanced Medicine has positioned itself as one of the leaders in the field. I am honored to work with the dedicated and accomplished team of researchers and innovators at LAM to further advance the company’s technology and work to save lives through early cancer detection," said Dr. Chahine.

On November 4, 2019 Revolution Medicines, Inc., a clinical-stage oncology company focused on developing targeted therapies to inhibit elusive frontier targets within notorious cancer pathways, reported an agreement with Amgen to evaluate the combination of RMC-4630, the company’s investigational SHP2 inhibitor, and AMG 510, Amgen’s investigational KRASG12C inhibitor (Press release, Revolution Medicines, NOV 4, 2019, View Source [SID1234550253]). Amgen will conduct a Phase 1b clinical trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of AMG 510 in combination with RMC‑4630 in subjects with advanced solid tumors harboring the KRASG12C mutation. Revolution Medicines will provide Amgen with clinical supply of RMC-4630 for the planned study.

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RMC-4630 and AMG 510 are selective investigational inhibitors of oncogenic targets at distinct positions within the RAS signaling cascade that are frequently exploited by human cancers. RMC-4630 is a potent and orally bioavailable small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. RMC-4630 and SHP2 are the focus of an exclusive global research, development and commercialization agreement with Sanofi. AMG 510 is designed to selectively and irreversibly target the KRASG12C protein, an oncogenic RAS mutant at the core of the RAS signaling cascade.

Preclinical and clinical research has shown that cancers caused by KRASG12C and other RAS pathway mutations exhibit "oncogene addiction," in which tumor cells are highly dependent on RAS pathway signaling to survive. Such tumors can develop adaptive resistance by hijacking cell signaling circuitry to circumvent pathway inhibitors and restore RAS signaling. The planned clinical Phase 1b study is the first step in evaluating whether inhibition of the RAS pathway at two nodes simultaneously through the combination of RMC-4630 and AMG 510 increases the depth or durability of clinical benefit for patients with tumors bearing KRASG12C.

"We and our partner Sanofi are committed to a clinical strategy that includes exploring in-pathway combinations including RMC-4630 to optimize treatment options for patients with RAS-dependent tumors. This collaboration with Amgen, a clinical pioneer in the field, provides another opportunity to leverage RMC-4630," said Mark A. Goldsmith, M.D., Ph.D., president and chief executive officer of Revolution Medicines. "Our development program for RMC-4630 currently includes an ongoing Phase 1 monotherapy trial, an ongoing Phase 1b/2 study evaluating a combination with cobimetinib, a MEK inhibitor, and a planned Phase 1b trial evaluating a combination with AMG 510, the leading investigational KRASG12C inhibitor."

About RMC-4630 and Sanofi Collaboration

RMC-4630 is currently being evaluated in a Phase 1 monotherapy clinical trial (RMC-4630-01) for a range of tumor types featuring specific, molecularly-defined oncogenic mutations, as well as a Phase 1b/2 study (RMC-4630-02) in combination with cobimetinib in patients with relapsed/refractory solid tumors displaying specific genomic mutations. The RMC-4630 program is the focus of an exclusive global research, development and commercialization agreement with Sanofi, under which Revolution Medicines received a $50 million upfront payment, and Sanofi agreed to reimburse the Revolution Medicines for substantially all research and all development costs for the joint SHP2 program. Sanofi received an exclusive worldwide license for global commercialization of any approved products targeting SHP2, subject to a U.S. co-promote right for Revolution Medicines. The companies have agreed to enter into a 50/50 profit and loss share arrangement in the U.S., and Revolution Medicines is entitled to receive tiered royalties on annual net sales ranging from high single digit to mid-teen percentages on sales in other markets. Revolution Medicines could also receive more than $500 million in development and regulatory milestone payments.

On November 4, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported that the Company plans to release its third quarter 2019 financial results on Wednesday, November 13, 2019 after the market closes (Press release, China Biologic Products, NOV 4, 2019, View Source [SID1234550252]).

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The Company’s management will hold a conference call at 7:30 a.m. ET on Thursday, November 14, 2019, which is 8:30 p.m. Beijing Time on November 14, to discuss third quarter 2019 results. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905945

China:

4001 201203

A telephone replay will be available one hour after the conclusion of the conference call through November 21, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10136730

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

On November 4, 2019 Luminex Corporation (Nasdaq: LMNX) reported results for its third quarter ended September 30, 2019 (Press release, Luminex, NOV 4, 2019, View Source [SID1234550251]).

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All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP"). Comparisons shown in this release are to the same period in the prior year unless otherwise noted.

CURRENT HIGHLIGHTS

Total revenue growth for the quarter of 9% to $78.7 million. Revenue reflects an $8.7 million addition from Flow Cytometry and a $6.9 million reduction attributable to the departure of certain sales to LabCorp.
Operating cash flow of $9.4 million.
Dividend declared of $0.09 per share.
ARIES MRSA Assay received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Submitted VERIGENE II Gastrointestinal Flex Assay to the FDA.
Expect to submit VERIGENE II Respiratory Flex Assay to the FDA by year end.
CEO COMMENTARY

"Consistent with our previously communicated plans, 2019 has been a transition year for Luminex as we have adjusted to the departure of certain sales to LabCorp and the integration of the Flow Cytometry acquisition," said Nachum "Homi" Shamir, President & CEO. "Although total revenue was slightly lower than expected due to order timing in Flow Cytometry in the third quarter, I am very pleased with the significant progress we are making to return the company to sustained growth and profitability," continued Shamir. "We anticipate a new and transformative era for Luminex as a more diversified company, with strong organic growth, profitability, and cash flow, that will be offering exciting new platforms and opportunities across each of our major product lines. Next year will be the first time in Luminex’s history where we launch three exciting new platforms across our portfolio."

RESULTS AND REVENUE SUMMARY FOR THIRD QUARTER 2019

Licensed Technology Group revenue increased 7% to $38.7 million, driven by consumable and royalty revenue growth.
Molecular Diagnostic revenue declined 15% to $30.3 million (up 6% without the revenue decline from the departure of LabCorp). The growth, absent the LabCorp effect, was primarily attributable to increases in sample to answer portfolio revenue.
Molecular sample to answer portfolio revenue grew 27% to $17.4 million, with 31 new sample to answer molecular systems under contract in this third quarter. Active sample to answer customers grew to more than 650 in the quarter.
Flow Cytometry contributed revenue of approximately $8.7 million in the quarter and $33 million year to date, a 10+% increase. While order timing of approximately $3 million in Flow Cytometry resulted in slightly lower revenue than expected in the third quarter, Flow is on track to deliver $12 million in the fourth quarter and $45 million in 2019, as expected, with an anticipated growth rate above 10% in 2019.
Gross margins of 53% were affected primarily by the departure of higher margin LabCorp revenue, as well as growth across all of the company’s lower margin items.
Net loss of $5.3 million, or $0.12 per diluted share, was impacted primarily by the departure of LabCorp revenue and the integration of the Flow Cytometry acquisition and resulting margin compression.

FINANCIAL OUTLOOK AND GUIDANCE

For the full year 2019, the Company is adjusting its revenue expectations to a range of $334 million to $337 million.

CONFERENCE CALL

Management will host a conference call at 4:00 p.m. Central Time / 5:00 p.m. EST, Monday, November 4, 2019 to discuss the operating highlights and financial results for the third quarter 2019. The conference call will be webcast live and may be accessed at Luminex Corporation’s website at View Source The presentation slides will be posted to our Investor Relations website after the market close on November 4, 2019. Analysts may participate on the conference call by dialing (877) 930-7053 (U.S.) or (253) 336-7290 (outside the U.S.). The access code is 1293259. The webcast will be archived for six months on our website using the ‘replay’ link.

At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at luminexcorp.com.