Today (Monday), Israeli MedTech startup PixCell Medical, developer of a full-blood-count diagnostic solution at point-of-care, announced that the Australian Therapeutic Goods Administration (TGA) has approved the market and use of PixCell’s HemoScreen diagnostics device. The Israeli company had already formed commercial partnerships with a number of Australian based distributors to bring the rapid diagnostics to the ‘Land Down Under’, with even the Australian government deploying the blood-based diagnostics device as a way to monitor COVID patients remotely.

"Lab-on-a-cartridge"

PixCell developed and patented Viscoelastic Focusing (VEF) technology, which causes cells to line up in a single cell plane. This phenomenon forms the basis of PixCell's AI-driven solution, which leveraging advanced computer vision technology, can rapidly analyze and differentiate cells within a sample. The hematology diagnostics analyzer provides insights on 20 CBC parameters as well as comprehensive abnormal cell flagging. This empowers doctors with early detection capabilities for various diseases, including cancer.

"We are delighted to receive TGA approval and are already in the process of making HemoScreen available to patients in Australia," said PixCell Medical CEO Dr. Avishay Bransky. "Almost 30% of Australians live in rural areas making access to many healthcare services difficult. To take a simple blood test, one may have to travel hours to the nearest city or have blood samples flown out to a lab, causing significant delays in receiving results. This technology makes the most common complete blood count (CBC) test accessible locally when results are needed quickly," Bransky explained.

The HemoScreen device is designed to be simple for users. It requires no maintenance or calibration and does not require technical expertise to operate. The whole CBC testing process entails three steps from sample collection to results delivery, and eliminates the manual sample preparation procedure, which can generally compromise test results. A single drop of blood is collected in PixCell's "lab-on-a-cartridge," which is outfitted with all necessary reagents; the cartridge is inserted into the HemoScreen and within 6 minutes, the device provides lab-accurate results. Having blood test results on the spot allows clinicians to make decisions based on accurate data when they are in front of their patients, improving care delivery and clinical decision making.

PixCell was founded in 2008 by CEO Avishay Bransky and Chairman Max Herzberg. The company’s headquarters are based in one of Israel’s northern tech hubs. PixCell Medical's product already has the backing of FDA and CE approval as the company enters the Australian market. Under the TGA approval, PixCell's HemoScreen is cleared for use with adults and infants alike, from as early as 2 months of age.