Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. NanoString Technologies struck a deal with pharma giant Merck to develop a companion diagnostic for the drugmaker's new cancer treatment. More cases of Zika are cropping up and the FDA has cleared the first test to screen for the virus. MD Biosciences is also getting in on the effort, rolling out a lab-developed test for Zika. Last but certainly not least, Belgium's MDxHealth got good news for its prostate cancer test after a leading group of U.S. cancer centers recommended the tool. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
NanoString Technologies strikes companion Dx deal with Merck
It's been a busy few weeks of companion diagnostic deals, and now, NanoString Technologies ($NSTG) is jumping on the bandwagon. The Seattle-based company has expanded its agreement with pharma titan Merck ($MRK) to create a test that looks at patients' response to treatment with Merck's immuno-oncology drug Keytruda.
Under the terms of the deal, NanoString will get up to $24 million for access to its technology and milestones, and may also receive additional milestone payments in the future. The company will handle regulatory approval and marketing for its diagnostic test, NanoString said in a statement.
The deal builds on a previous agreement between the companies. NanoString and Merck are already working on a test that could predict which patients could benefit from treatment with Keytruda. But the latest deal is aimed at developing and marketing a selected gene expression signature to see how patients with multiple tumor types respond to the therapy. "We believe this gene signature has the potential to become the basis for a universally available assay that serves as the 'gold standard' for informing treatment with immuno-oncology therapies," NanoString CEO Brad Gray said in a statement. Statement
FDA gives emergency green light to Zika diagnostic as epidemic rages on
The FDA granted emergency clearance for the first test to detect Zika. There are no other approved diagnostics to screen for the virus, so the FDA blessing comes at a critical moment.
Last month, Secretary of Health and Human Services (HHS) Sylvia Burwell said that the virus holds "significant potential for a public health emergency," which prompted the FDA to issue its clearance for the Zika test, FDA Commissioner Robert Califf said in a note to the Centers for Disease Control and Prevention (CDC). The test, which was developed by the CDC, can flag the presence of anti-Zika antibodies in a patient's blood or spinal fluid.
Minnesota-based diagnostics company MD Biosciences is also joining the Zika-fighting effort. This week, the company rolled out its lab-developed test for Zika, which can distinguish the virus from other, similar infections including dengue, West Nile or Chikungunya, the company said in a statement. Letter (PDF) | Release
MDxHealth chalks up win for prostate cancer test with leading U.S. cancer group
Belgium's MDxHealth scored some points for its prostate cancer test this week after a group of leading cancer centers endorsed the company's tool. The National Comprehensive Cancer Network (NCCN), which comprises 23 U.S. cancer centers, issues recommendations every year about tests that could improve treatment for patients. Getting published in the NCCN's guidelines could help MDx Health gain momentum for its test.
The NCCN based its decision on promising clinical data. MDxHealth's test can weed out a significant number of false negative results, which could in turn reduce patients' need for repeat biopsies and other invasive procedures.
"Gaining acceptance into the NCCN Guidelines has been at the core of our medical affairs strategy, and supported by our investment in building a strong dossier of clinical evidence," MDxHealth COO Christopher Thibodeau said in a statement. "This is a major milestone for the Company which paves the way for widespread adoption of the assay within the US urology community, and as importantly, strengthens our position to negotiate with health insurance plans." Release