Keeping you up to date on recent developments in diagnostics.

"Microbiome" has become a health and wellness buzzword, implicated as a contributing factor in conditions ranging from diabetes and obesity to gastrointestinal disease, autoimmune diseases and even autism. But the tools scientists use to cultivate bacteria have changed little over the past century, said Peter Christey, founder and CEO of San Carlos, Calif.-based startup General Automation Lab Technologies Inc. (GALT).

Prostate cancer affects roughly 1 in 9 American men in their lifetime, with 174,650 new cases reported each year. However, current prostate specific antigen (PSA) tests lack specificity, leading to overdiagnosis and overtreatment of inconsequential cancers. Cleveland Diagnostics Inc. is looking to change that with its IsoPSA assay, which just received a breakthrough device designation from the U.S. FDA. In clinical studies, the noninvasive, blood-based test has been shown to have higher accuracy than standard PSA tests.

Abbott Laboratories and Tandem Diabetes Care Inc. said Tuesday that they plan to develop and commercialize a line of integrated diabetes products based on Abbott's glucose sending technology and Tandem's insulin delivery systems. The collaboration comes as the U.S. FDA is encouraging medical device manufacturers to consider the ability to share and use information safely and effectively in the development and design of connected devices.

Polarityte Inc., of Salt Lake City, reported positive results from a pilot study of its Skinte regenerative skin product in the closure of venous stasis leg ulcers (VLUs) after standard treatments have failed. The findings were reported at the Symposium on Advanced Wound Care fall meeting, Oct. 12-14, in Las Vegas.

"Microbiome" has become a health and wellness buzzword, implicated as a contributing factor in conditions ranging from diabetes and obesity to gastrointestinal disease, autoimmune diseases and even autism. But the tools scientists use to cultivate bacteria have changed little over the past century, says Peter Christey, founder and CEO of San Carlos, Calif.-based startup General Automation Lab Technologies Inc. (GALT). His firm is hoping to change that with a high-throughput system of hugely parallel arrays and high-resolution images of complex samples that will revolutionize the way microbiology laboratories process genetic material.

San Clemente, Calif.-based Glaukos Corp. has finished enrolling patients in its U.S. investigational device exemption (IDE) trial for the Istent Infinite trabecular micro-bypass system, which is intended for standalone use in lowering intraocular pressure (IOP) in refractory glaucoma patients. If all goes as planned, the company is looking to commercially launch the treatment in the U.S. in 2021.

Houston-based startup Braincheck Inc. scooped up $8 million in series A funding in a round led by S3 Ventures and Tensility Venture Partners, along with True Wealth Ventures and Nueterra Capital. Braincheck launched its digital cognitive assessment tool in 2015 and a cognitive care planning solution in 2018, and now the company is looking to broaden its footprint with physician practices, hospitals and health systems. Proceeds from the financing will help to build the company's sales and marketing and clinical development teams in Houston, as well as production development staff in Austin.

The U.S. FDA has given Pq Bypass Inc. the greenlight to conduct a pivotal trial aimed at assessing its Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. The TORUS-2 study is the Milpitas, Calif.-based startup's second IDE approval in less than two years and the first pivotal IDE for an SFA stent graft since W.L. Gore & Associates Inc.'s Viabahn device, which notched an initial PMA approval in 2005.