On July 8, 2020 Thermo Fisher Scientific reported that it has signed a companion diagnostic (CDx) agreement with Chugai Pharmaceutical Co., Ltd., a member of the Roche Group, and has applied to the Ministry of Health, Labour and Welfare (MHLW) to expand the use of the Oncomine Dx Target Test in Japan (Press release, Thermo Fisher Scientific, JUL 8, 2020, View Source [SID1234561773]). The CDx will be leveraged to identify ROS1-positive non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with entrectinib (Rozlytrek). Approval by the MHLW would accelerate access to Chugai’s targeted therapy via a locally administered, next-generation sequencing (NGS) biomarker test.

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!

Entrectinib received MHLW approval in February 2020 to treat ROS1-positive NSCLC adult patients. Prior to that, the drug received accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2019 to treat ROS1-positive NSCLC adult patients, and both adult and pediatric patients with solid tumors that have NTRK gene fusions. ROS1 gene fusions are prevalent in 1-2 percent of NSCLC cases. It is one of 46 cancer-related biomarkers evaluated by the MHLW-approved version of Thermo Fisher’s Oncomine Dx Target Test. The MHLW previously approved the test as a CDx for four biomarkers – EGFR, ALK, ROS1 and BRAF – associated with 12 targeted therapies for NSCLC. The test was previously approved to identify ROS1-postitive patients for treatment with crizotinib in the U.S.

Oncomine Dx Target Test is currently reimbursed by government and commercial insurers in the U.S., Europe, Japan and South Korea, covering more than 550 million lives globally. Lung cancer is the leading cause of cancer deaths worldwide, and each year the disease causes more than 1.6 million deaths – more than breast, colon and prostate cancers combined. In Japan, lung cancer is the leading cause of cancer deaths in men, making up about 25 percent of all male cancer deaths in 2015.1

"Since receiving premarket approval for Oncomine Dx Target Test in 2017, Thermo Fisher has accelerated its endeavor to expand the use of comprehensive biomarker testing globally," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher. "Our latest agreement underscores this commitment to build on the Oncomine Dx Target Test, which is still the first-and-only approved NGS companion diagnostic in Japan that is administered locally to expedite patient testing in the region."

On July 8, 2020 Luminex Corporation (Nasdaq: LMNX) reported 2nd quarter 2020 revenues of between $109 and $110 million, up more than 30% over the 2nd quarter of 2019 (Press release, Luminex, JUL 8, 2020, View Source [SID1234561772]). Highlights include:

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!

Molecular Diagnostics revenue of approximately $65 million, up over 100% vs. Q2 2019
Sample-to-answer MDx revenue of approximately $30 million, up nearly 65% vs. Q2 2019
Non-automated MDx assay revenue of approximately $35 million, up nearly 150% vs. Q2 2019
Automated MDx assay revenue of approximately $26 million, up more than 55% vs. Q2 2019
170 sold or contracted sample-to-answer systems, the majority of which were ARIES Systems
Strong demand driven by pandemic-related sales across all Respiratory/COV-19 products
Licensed Technologies Group revenue of approximately $35 million, down 5% vs. Q2 2019
Placed approximately 210 xMAP systems
Partially affected by slowdown in research market
Flow Cytometry revenue of more than $7 million, down over 45% vs. Q2 2019
Up sequentially by approximately 10%
Continues to be significantly affected by slowdown in academic research
Had an additional $2 million of confirmed orders that were not able to be installed due to the COVID-19 pandemic
"We finished the quarter with record revenue of between $109 and $110 million," said Nachum "Homi" Shamir, President and CEO of Luminex. "With the EUA clearance of our IgG serology assay, we have expanded the breadth of our portfolio and believe that we are well positioned to continue to play a pivotal role in combating the COVID-19 pandemic. In addition, the remainder of our business continues to be healthy, and with xMAP INTELLIFLEX Systems now in our Partners’ hands, we are positioned to further strengthen our partnership business with this state-of-the-art platform."

The full financial results for the quarter, and any changes to 2020 guidance and/or provision thereof, will be discussed on our second quarter earnings call, currently scheduled for August 3, 2020.

On July 8, 2020 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in total talent solutions for healthcare organizations, reported that has scheduled a conference call to discuss its second quarter 2020 financial results on Thursday, August 6, 2020 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, JUL 8, 2020, View Source [SID1234561771]). The same day, the Company also expects to issue an earnings news release after market close at approximately 4:15 p.m. Eastern Time.

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!

A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (833) 968-2219 in the U.S., or +1 778-560-2894 for international callers, and using participant code 5756627. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 8 p.m. Eastern Time on August 6, 2020, and can be accessed until 11:59 p.m. Eastern Time on August 20, 2020 by calling (800) 585-8367 in the U.S. or +1 416-621-4642 internationally, with access code 5756627.

On July 8, 2020 On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, reported that it has announced that it has enrolled the first patient in the ELUCIDATE Trial, a Phase 3 clinical trial evaluating the efficacy and safety of pafolacianine sodium (formerly OTL38) in the intraoperative detection of lung cancer lesions (Press release, On Target Laboratories, JUL 8, 2020, View Source [SID1234561770]).

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!

"This pivotal study is pioneering the use of fluorescence guidance to intraoperatively identify lung cancer in real-time," said Sunil Singhal, M.D., Vice Chair, Translational Research and the William Maul Measey Associate Professor in Surgical Research in the Perelman School of Medicine at the University of Pennsylvania and a member of Penn’s Abramson Cancer Center and principal investigator of the study. "Using a fluorescent imaging marker with high affinity and specificity for lung cancer allows surgeons to more effectively remove all the malignant tissue and have greater confidence in a complete resection."

The Phase 3 study will assess the efficacy, safety, and tolerability of pafolacianine sodium in patients with lung cancer. This multi-center trial is expected to enroll up to 130 patients. Top-line data from the trial are expected in 2021.

"Treating our first patient in the ELUCIDATE Phase 3 Trial is an enormous achievement for On Target Laboratories," said Chris Barys, CEO of On Target Laboratories. "We believe this transformational technology should become the standard of care and look forward to bringing it to market so more lung cancer patients can benefit from the improved outcomes associated with more complete tumor resections."

About Fluorescence-guided Surgery

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ fluorescent markers are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, lighting the way for the resection of malignant tissue and enabling surgeons to see and remove more diseased tissue.

On Target’s first novel compound, pafolacianine sodium, targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A small single dose of the compound is administered via intravenous infusion prior to surgery, allowing the surgeon to identify malignant tissue during the procedure using a near-infrared camera.

On July 8, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its second quarter 2020 financial and operating results on Wednesday, August 5, 2020, before the U.S. financial markets open (Press release, Regeneron, JUL 8, 2020, https://www.prnewswire.com/news-releases/regeneron-to-report-second-quarter-2020-financial-and-operating-results-and-host-conference-call-and-webcast-on-august-5-2020-301089994.html [SID1234561769]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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!

Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.