LEXINGTON, Mass., July 18, 2017  -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, announced today that it has received a CE Mark for its T2Bacteria Panel, allowing for the sale and distribution of the product within the European Union and those countries accepting the CE Mark. The T2Bacteria Panel runs on the Company’s proprietary T2Dx® Instrument and provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture. The T2Bacteria Panel is currently available in the United States for Research Use Only (RUO) and the Company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA. Patient enrollment in the trial is currently 92% complete and the company is very pleased with the product performance demonstrated to date, which for the prospective arm of the study is showing an average sensitivity of 96% and average specificity of 98%.

GAITHERSBURG, Md., July 12, 2017 -- OpGen, Inc. (NASDAQ:OPGN) announced today that the New York State Department of Health (NYSDOH) has approved the Acuitas® MDRO Gene Test for use by physicians and healthcare providers in the state. The approval of OpGen’s CLIA laboratory to perform testing in New York State includes approval for the complete OpGen MDRO testing workflow, including MDRO gene testing on perianal swabs and clinical isolates. The NYSDOH regulates and oversees clinical diagnostic laboratories that test specimens from the state residents.

 

The Acuitas MDRO Gene Test is a CLIA lab-based test able to provide information regarding the presence of ten MDRO resistance genes from one patient specimen. The ten drug-resistant genes identified by our Acuitas MDRO Gene Test are associated with CRE, ESBL and VRE organisms, and are gastrointestinal organisms frequently associated with antibiotic-resistant infections. The test results can be used by healthcare providers to identify patients colonized with organisms expressing the drug-resistant genes or who are actively infected.

PARSIPPANY, N.J., June 28, 2017  -- Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management announced today that it has signed a new national contract with Aetna for its ThyGenX ®and ThyraMIR® molecular tests for indeterminate thyroid nodules.

 

Aetna is the third largest health plan in the United States, with over 44.9 million members nationwide. The agreement covers many of Aetna’s products, including commercial and Medicare Advantage plans. It does not include Medicaid, auto insurance, or workman’s compensation products. The agreement goes into effect August 15, 2017. Aetna began covering ThyGenX in June 2015 and ThyraMIR in November 2016. 

WEST PALM BEACH, FL--(June 27, 2017) - Rennova Health, Inc. (NASDAQ: RNVA), (NASDAQ: RNVAZ) ("Rennova" or the "Company"), a vertically integrated provider of industry-leading diagnostics and supportive software solutions for healthcare providers, announced today an agreement between its subsidiary Advanced Molecular Services Group, Inc. (AMS Group) and Certainty Health, LLC, a pioneer in cloud-based mobile applications for patient-focused health information. The partnership will develop next generation smartphone tools to enable patients, families, and their healthcare teams to confidently assess the importance of a patients' genetic background in treatment decisions for various psychiatric diseases.

 

"We look forward to working with Rennova Health to expand a mobile precision medicine platform to immediately address the unmet needs of patients and their caregivers for relevant molecular information impacting psychiatry today," stated Dr. Chris Yoo, President and COO of Certainty Health. "Rennova's incredibly rich and growing databases of pharmacogenomic drug metabolism data represents over a decade of real-world diagnostic results for multiple diseases and together with Rennova, we will democratize access to this knowledge for the benefit of patients."