On September 8, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported Helen Sabzevari, PhD, President and CEO of Precigen, will present at the virtual H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, at 10:30 AM ET (Press release, Precigen, SEP 8, 2020, https://www.prnewswire.com/news-releases/precigen-to-present-at-hc-wainwright-22nd-annual-global-investment-conference-301125199.html [SID1234564791]). Participants may access the live webcast of the virtual event through Precigen’s website in the Press & Events section at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On September 8, 2020 Thermo Fisher Scientific reported that The U.S. Food and Drug Administration (FDA) has granted premarket approval to Oncomine Dx Target Test as a companion diagnostic (CDx) to identify RET fusion-positive, metastatic non-small cell lung cancer (NSCLC) patients who are candidates for GAVRETO (pralsetinib), a targeted therapy developed by Blueprint Medicines (Press release, Thermo Fisher Scientific, SEP 8, 2020, View Source [SID1234564790]). The Oncomine Dx Target Test was initially approved in 2017 as the first targeted next-generation sequencing (NGS)-based CDx for biomarkers associated with three FDA-approved NSCLC therapies. It is now also the first and only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC. Thermo Fisher will update the Oncomine Dx Target Test to enable it to report RET fusions in the U.S. before the end of the year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Oncomine Dx Target Test simultaneously evaluates 23 genes clinically associated with NSCLC. In 2017, the FDA approved it as a CDx to identify patients who may be eligible for specific targeted therapies.
GAVRETO is a potent and selective once-daily oral therapy designed to target RET fusions and mutations. GAVRETO was granted accelerated approval by the FDA on Sept. 4 for the treatment of adult patients with metastatic RET fusion-positive NSCLC. The approval was based on data from the ongoing Phase 1/2 ARROW clinical trial in patients with RET fusion-positive NSCLC with or without prior therapy.

RET fusions are believed to be key disease drivers in about 1-2 percent of patients with NSCLC, which accounts for 85 percent of all lung cancers in the United States.1 New data show that NSCLC mortality has been declining in recent years, suggesting that advances in treatment, including targeted therapies, may be contributing to improved survival rates.2 RET fusions are on the list of key markers recommended for multi-biomarker testing in NSCLC by National Comprehensive Cancer Network (NCCN) guidelines. The approval now provides NSCLC patients the only path to receive rapid assessment of their RET fusion status with an approved NGS test.

The Oncomine Dx Target Test simultaneously evaluates 23 genes clinically associated with NSCLC. In 2017, the FDA approved it as a CDx to identify patients who may be eligible for specific targeted therapies. The test has also been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for four biomarkers – EGFR, ALK, ROS1 and BRAF – associated with 12 targeted therapies for NSCLC.

Most recently, the MHLW approved the test to assess patients who may be eligible for treatment with entrectinib (Rozlytrek) following a CDx agreement Thermo Fisher signed earlier this year with Chugai Pharmaceutical Co., Ltd., a member of the Roche Group. The Oncomine Dx Target Test is currently approved and reimbursed by government and commercial insurers in the U.S., Europe, Japan, South Korea and Israel, covering more than 550 million lives globally.

"It is our goal to provide cancer patients globally greater access to highly actionable, NGS-based multi-biomarker testing in important indications like NSCLC as recommended by multiple guidelines. Today’s approval underscores this endeavor," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Our tests are designed to require the least amount of sample of any NGS IVD test on the market, leading to more patients benefiting from the test and put on the right therapy upfront. As part of our commitment, we remain focused on developing our next generation companion diagnostic by taking Oncomine Precision Assay and the Genexus System through the FDA’s approval process."

On September 8, 2020 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in two upcoming virtual conferences (Press release, BioMarin, SEP 8, 2020, View Source [SID1234564789]). An audio webcast of the presentations will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On September 8, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular technologies designed to provide physicians with clinically actionable information to improve patient outcomes, reported it has entered into an agreement with Health Net Federal Services LLC to be an in-network provider for its Target Selector liquid biopsy oncology platform for the TRICARE West (TriWest) region network (Press release, Biocept, SEP 8, 2020, View Source [SID1234564788]). TriWest provides healthcare services to approximately three million members of the U.S. military and their families.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"It’s an honor to become a provider for TriWest and to support the healthcare needs of our country’s military service members and their families," said Michael Nall, President and CEO of Biocept. "Our Target Selector platform can be used to improve treatment outcomes by helping physicians rapidly obtain the actionable information they need to design personalized treatment plans for their patients diagnosed with cancer. Expanding the number of managed care agreements is among our strategic objectives. Our liquid biopsy platform is available on an in-network basis to millions of patients across the U.S. and now we are very proud to include those who are serving our country as they fight a new battle, this time with cancer."

About TRICARE West Region Network
TRICARE is the worldwide healthcare program available to eligible beneficiaries of the seven uniformed services – the Army, U.S. Navy, U.S. Air Force, U.S. Marine Corps, U.S. Coast Guard, Commissioned Corps of the U.S. Public Health Service, and the Commissioned Corps of the National Oceanic and Atmospheric Administration. TRICARE-eligible beneficiaries may include active duty service members and their families, retired service members and their families, National Guard and Reserve members and their families, survivors, certain former spouses, and others. TRICARE is jointly managed by the Defense Health Agency (DHA) and the TRICARE Health Plan. The DHA has partnered with civilian regional contractors in the East and West regions to assist TRICARE regional directors, and military hospital and clinic commanders in operating an integrated health care delivery system

TriWest is managed under a contract with the DHA by Health Net Federal Services. Coverage includes the states of Alaska, Arizona, California, Colorado, Hawaii, Idaho, Iowa (except the Rock Island Arsenal area), Kansas, Minnesota, Missouri (except the St. Louis area), Montana, Nebraska, Nevada, New Mexico, North Dakota, Oregon, South Dakota, Texas (areas of Western Texas only), Utah, Washington, and Wyoming. More information is available at www.tricare-west.com.

On September 8, 2020 Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal ablation, reported that it has closed on an initial $3 million in a Series B-1 financing with total approved capital of up to $6 million in the raise (Press release, Nanospectra Biosciences, SEP 8, 2020, View Source [SID1234564787]). The equity round was led by Sirtex Medical as a strategic investor with additional participation from existing and new investors. Sirtex is a leading U.S. based provider of targeted liver cancer therapies via their proprietary SIR-Spheres Y-90 microspheres with global operations. Kevin P. Smith, Sirtex’s General Counsel and Executive Vice President, Business Development, will join the Nanospectra Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AuroLase, Nanospectra’s lead product, is the first and only ultra-focal ablation therapy designed to maximize treatment efficacy while minimizing side effects typically associated with surgery, radiation and alternative focal therapies. Proceeds from the financing will be used to further develop AuroLase, including full completion of the ongoing pivotal study for prostate cancer tissue ablation, filing of a 510(k) with the U.S. Food and Drug Administration (FDA) for marketing clearance, and preparing for commercialization. In addition, Sirtex and Nanospectra have agreed to exclusively negotiate for a defined period of time for access to AuroLase in certain geographies outside of the U.S.

"We are thrilled to welcome Sirtex Medical as a strategic investor due to their shared commitment and understanding of the clinical and patient benefits of minimally-invasive oncology therapies," said David Jorden, CEO of Nanospectra. "With established global operational capabilities and distribution, they are well positioned to advise on our commercialization efforts in both the U.S. and other geographies. We look forward to Sirtex’s active engagement as we proceed with our clinical programs."

The AuroLase pivotal study for the focal ablation of prostate tissue via nanoparticle directed near infrared irradiation is approved by the FDA under the original Investigational Device Exemption (IDE) and follows the successful first-in-human pilot study that enrolled 46 subjects at three U.S. sites. The ongoing pivotal study will enroll up to 60 patients at up to eight clinical trial sites throughout the U.S. and the combined dataset from both studies will constitute the clinical package Nanospectra will submit to the FDA.

"Nanospectra’s AuroLase is a perfect complement to our technology approach and corporate strategic focus on minimally-invasive therapies," said Kevin R. Smith, CEO of Sirtex Medical. "We look forward to collaborating with Nanospectra to explore and develop innovative therapies to meet unmet medical needs in patients with various cancer conditions."