On October 15, 2020 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, October 29, 2020 to report its third quarter 2020 financial results and provide a corporate update (Press release, Moderna Therapeutics, OCT 15, 2020, View Source [SID1234568531]).

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To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 1938847. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

On October 15, 2020 Guardant Health, Inc. (Nasdaq: GH) ("Guardant Health"), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported the closings of an underwritten public offering of 7,700,000 shares of its common stock, which includes full exercise of the underwriter’s option to purchase 700,000 shares, at a public offering price of $102.00 per share, before deducting underwriting discounts and commissions, all of which were sold by SoftBank Investment Advisers (Press release, Guardant Health, OCT 15, 2020, View Source [SID1234568530]). The initial closing of 7,000,000 shares occurred on October 9, 2020, and the closing of the underwriter’s option to purchase additional shares occurred today.

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Guardant Health did not sell any of its shares in the offering and did not receive any of the proceeds from the sale of shares in the offering by SoftBank Investment Advisers.

J.P. Morgan Securities LLC acted as sole book-running manager of the offering.

The public offering was made pursuant to an automatic shelf registration statement on Form S-3 that was filed by Guardant Health with the U.S. Securities and Exchange Commission (the "SEC") and automatically became effective upon filing. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 15, 2020 bioAffinity Technologies, a privately held biotech company, and Smiths Medical, a leading global medical device manufacturer, reported a partnership to improve patient care with at-home collection of sputum to be analyzed by CyPath Lung, a non-invasive flow cytometry diagnostic test for lung cancer that is being developed as a Laboratory Developed Test (LDT) by Precision Pathology Services (Press release, BioAffinity Technologies, OCT 15, 2020, View Source [SID1234568529]).

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"The partnership enables the use of the acapella vibratory PEP therapy system made by Smiths Medical for at-home collection of samples that are analyzed by bioAffinity’s CyPath Lung, a patient-friendly test shown to have high sensitivity and specificity in detecting lung cancer in people at high risk for the disease," said bioAffinity Technologies President and CEO Maria Zannes. "One of the hallmarks of CyPath Lung is the ease by which patients collect their sputum samples at home using the acapella device."

"Innovation is a cornerstone of Smiths Medical. As a leader in airway management solutions, we are proud that our acapella device can facilitate the use of this non-invasive breakthrough test that can detect lung cancer at its earliest stages when treatment can be most effective and lives can be saved," said JehanZeb Noor, Chief Executive Officer, Smiths Medical. "Smiths Medical and bioAffinity Technologies share a commitment to putting patients first and making quality healthcare accessible and affordable."

CyPath Lung is a flow cytometric test to aid in the diagnosis of lung cancer. Patients collect sputum samples non-invasively at home using the acapella device. The sample is shipped overnight to the laboratory for processing. Sample data is acquired by flow cytometry, a technique that can count, sort and profile individual cells quickly. Using an automated analysis with pre-set parameters, CyPath Lung profiles the lung micro-environment including the presence of cancer-associated cells. Test results can be provided to the physician in minutes.

A test validation trial conducted by bioAffinity Technologies comparing people at high risk for lung cancer to high-risk patients with the disease resulted in CyPath Lung specificity of 88% and sensitivity of 82%, similar to far more invasive procedures currently used to diagnose lung cancer. CyPath Lung performed even better, with 92% sensitivity and 87% specificity, in the group of cancer and cancer-free high-risk participants who had no nodules or small nodules less than 2 cm in diameter. Results of the test validation trial have been submitted for presentation at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer.

Precision Pathology Services has licensed and is developing CyPath Lung as a Laboratory Developed Test (LDT) in accordance with the College of American Pathologists (CAP) and the Clinical Laboratory Improvement Amendment (CLIA) guidelines and regulations. Precision Pathology Services is an accredited CAP/CLIA laboratory in San Antonio, Texas. Following completion of development of CyPath Lung as an LDT, physicians may order the test for their patients who are smokers and former smokers at high risk for lung cancer and who receive a positive screening result or otherwise are suspected of having the disease.

People who have smoked the equivalent of one pack of cigarettes a day for 30 years or more, have not quit smoking in the past 15 years and are 55-80 years of age are recommended for annual screening by low dose computed tomography (LDCT). Screening by LDCT has been proven to detect lung cancer at earlier stages when it can be successfully treated, but screening has a low Positive Predictive Value (PPV) that can lead to unnecessary and risky procedures.

On October 15, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the company’s participation at the Immuno Series US Virtual meeting which will be held online, October 15-16, 2020 (Press release, Personalis, OCT 15, 2020, View Source [SID1234568528]).

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Personalis will present "Maximizing immunotherapy biomarker discovery with a multidimensional tumor immunogenomics platform," featuring the Personalis universal cancer immunogenomics approach, ImmunoID NeXT. Kedar Hastak, PhD, will present for Personalis. His presentation will focus on the current challenges facing investigators in immuno-oncological translational research including maximizing data generation from a single sample and the analysis of complex data.

Dr. Hastak will discuss how more accurate, predictive biomarker analysis may assist in the selection of effective combinatorial immunotherapy treatments for patients. Additionally, the complexity of both the tumor and tumor microenvironment suggests a comprehensive approach is needed for robust characterization of the cancer ecosystem. By combining highly sensitive, exome-scale DNA and RNA sequencing with advanced analytics, the ImmunoID NeXT Platform provides a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample preparation. Dr. Hastak will feature a case study demonstrating the ability of this immunogenomics profiling platform to uncover tumor escape mechanisms and to identify composite biomarkers of potentially greater predictive capacity from patients treated with immune checkpoint blockade. Additionally, the presentation will highlight NeXT Liquid Biopsy, an exome-wide liquid biopsy approach combined with ImmunoID NeXT, to further explore critical areas of tumor biology.

On October 15, 2020 Cellaria, Inc. (Wakefield, MA, USA), a scientific innovator with breakthrough tools for cancer research, reported that it has introduced three next generation Pancreatic Cancer cell lines, substantially boosting the value of in vitro methods in the development of more effective therapies (Press release, Cellaria, OCT 15, 2020, View Source [SID1234568527]). Difficult to detect and with a poor survival rate, Pancreatic Cancer remains a primary and illusive therapeutic target for researchers. The new cell models are scalable and stable, securely linked to specific patient tumor samples and supported by Cellaria quality control certifications, which include full cell line authentication. They directly facilitate more clinically relevant, translatable research and represent a major step forward for academic and industrial researchers working to advance more effective, personalized medicine and lead drug candidates.

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"Legacy cell lines are a crucial tool for cost-effective in vitro studies, but most do not securely represent the heterogeneity of the original patient tumor," said David Deems, CEO, Cellaria, Inc. "Genetic drift, selective overgrowth and/or contamination are recognized issues that erode the relevance of commercial lines, thereby compromising progress. In contrast, our novel cell models are extremely stable and have a strong, robustly authenticated connection to specific patient tumors. They offer breakthrough reproducibility, rigor and relevance in both clinical studies and drug discovery."

Pancreatic cancer tumors are elusive in conforming to standard definitions and tend to morph and metastasize into different cancers following treatment. Cellaria’s three new cell models – "Stew", "Chocolate", and "Basket" – are derived from patients diagnosed with pancreatic adenocarcinoma (the most common form of Pancreatic Cancer), and vary with respect to factors such as gender, ethnicity, age, treatment history, and diagnosis. As a result, they enable researchers to closely align their studies with a specific patient cohort, with defined molecular targets and biomarkers. All are provided with protocols for preserved biomarker expression and a Certificate of Analysis (COA) attesting their growth characteristics. Beyond supporting optimal application of the cell line, the COA meets growing requirements within the research community for demonstrable cell line authentication.

"In-depth scientific know-how is a hallmark of the Cellaria approach," said David Deems. "All our cell models are subject to extensive characterization assays including genomic and biomarker analysis, gene expression and protein profiling. Furthermore, we have data showing response to at least three approved drug therapies for each line. This information is a powerful aid to gathering useful, actionable data from the outset for new or established research groups. We’re delighted to add these new products to our established portfolio for breast, lung, colon, and ovarian cancers, to accelerate the progress of therapeutic and basic science towards a treatment for this challenging condition."

Cellaria cell models for a range of cancers have already demonstrated proven value in in vitro studies. Find out more about the potential impact of the Stew, Chocolate and Basket at: www.cellariabio.com or call 978-720-8051.