On January 8, 2020 KDx Diagnostics, Inc. (KDx), reported that the Food and Drug Administration (FDA) has granted "Breakthrough Device" designation for its URO17 Bladder Cancer Recurrence Test (Press release, KDx Diagnostics, JAN 8, 2020, View Source [SID1234552887]). This revolutionary new test exploits a novel cancer marker that could dramatically improve the accuracy and sensitivity of non-invasive bladder cancer testing.

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Bladder cancer is the 6th most common cancer in the US, and 81,000 people are newly diagnosed with the disease annually. Moreover, bladder cancer has a relatively high recurrence rate and is one of the most expensive patients to treat, in part because patients must be regularly monitored for recurrence.

KDx has published data (Babu et al., 2018) showing the URO17 test exhibited 100% sensitivity and 96% specificity in detecting recurrent bladder cancer from urine samples. While this was an initial study, these rates are among the best ever reported for a non-invasive test.

"The FDA’s designation of Breakthrough Device for our URO17 test validates our excitement about the potential of our test to improve bladder cancer treatment with attendant major impact in the marketplace for bladder cancer diagnostics. Breakthrough Device designation significantly enhances our ability to conduct the necessary clinical trials for approval and expedites the review process. We look forward to working closely with the FDA during this next exciting phase of product development," said Nam W. Kim, Ph.D., KDx’ Co-Founder and CEO.

On January 8, 2020 Nurix Therapeutics, Inc., a company developing targeted protein modulation drugs reported that CEO Arthur Sands will present at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 8:30 a.m. PST in San Francisco (Press release, Nurix Therapeutics, JAN 8, 2020, View Source [SID1234552853]).

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On January 8, 2020 Veracyte (Nasdaq: VCYT) reported a multi-year partnership with Acerta Pharma, the hematology research and development arm of AstraZeneca (LSE/STO/NYSE: AZN), to provide genomic information that will support the biopharmaceutical company’s development of oncology therapeutics (Press release, Veracyte, JAN 8, 2020, View Source [SID1234552870]). Financial and other terms of the collaboration were not disclosed.

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"We are excited to partner with Acerta Pharma and AstraZeneca, global leaders whose innovative medicines are benefitting millions of patients worldwide"

The agreement marks Veracyte’s first biopharmaceutical partnership since the company announced its acquisition of the exclusive diagnostics rights to the NanoString nCounter platform and genomic tests in breast cancer and lymphoma on December 3, 2019. That transaction positions Veracyte to expand globally using a distributed platform and comprehensive menu of advanced genomic tests.

"We are excited to partner with Acerta Pharma and AstraZeneca, global leaders whose innovative medicines are benefitting millions of patients worldwide," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "This collaboration reflects the significant value we can bring to biopharmaceutical companies through our expanding global footprint, as well as our ability to potentially inform diagnosis and treatment decisions in new oncology indications."

On January 8, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses and cancer vaccines to target hard-to-treat solid tumors, reported that it has entered into an exclusive option agreement with IOVaxis Therapeutics of Nantong, China, for clinical development and licensing of the Targovax mutant RAS vaccines TG01 and TG02 in China, Hong Kong, Macau and Singapore (Press release, Targovax, JAN 8, 2020, View Source [SID1234552888]).

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IOVaxis, a spin-off from ImmuOn Therapeutics, has secured an exclusive option to develop and license the TG01 and TG02 mutant RAS neoantigen vaccines in the above mentioned territories. The option can be exercised into an exclusive license by the earlier of i) the first regulatory approval to start a clinical trial in the territory, or ii) one year from the effective date of the Option Agreement. IOVaxis will pay Targovax USD 250.000 for this exclusive option. The milestone payment for the exercise of the option to license TG01/02 is USD 3 million.

Under the Option Agreement, IOVaxis and Targovax will jointly define a development plan in the territory, and IOVaxis will be responsible for all local regulatory filings and be the sponsor of clinical trials. The full License Agreement remains to be finalized, but the parties have pre-agreed the key commercial and operational terms in the Option Agreement. If exercised, the total potential development and commercial milestones for the TG01/02 license may reach up to USD 100 million, plus tiered royalties on net sales up to mid double digits.

On January 8, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report fourth quarter and full year 2019 results on Thursday, January 30, 2020, before the market opens (Press release, Quest Diagnostics, JAN 8, 2020, View Source [SID1234552854]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-357-4210 for domestic callers or 203-369-0125 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on January 30, 2020 until midnight Eastern Time on February 13, 2020.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.