News
inui™ Health Announces the First Clinical Grade Diagnostics Test Accessible to Everyone, Anywhere in the World, From Their Smartphone
inui™ Health, a Silicon Valley digital health company, announced the launch of its flagship diagnostics in-home urinalysis platform. The diagnostic platform, which includes a disposable test and smartphone app (iOS and Android), has received 510(k) clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA), plus a CE Mark certification. The tests have been used in multiple clinical studies in the United States and Africa and were also validated in Europe and the Middle East where inui™ has brought modern lab testing directly to patients in remote villages far from the nearest hospital.
inui™ Health delivers a cost-effective, clinically accurate healthcare diagnostics test in a less expensive, far more convenient manner than traditional urinalysis methods. To immediately view the results of inui™’s diagnostic test, users simply dip and use the phone guided app to conduct the test. The inui™ diagnostic system measures Protein, Glucose, Leukocytes, Nitrites and Ketones in urine and it can be used to monitor general health, kidney function, metabolic disorders (e.g. diabetes mellitus) and screen for urinary tract infections (UTI).
“We see an unprecedented opportunity in bringing powerful diagnostic tests currently only available at labs or clinics to the hands of consumers,” said Jaime Tenedorio, CEO of inui™ Health. “We are enabling individuals to perform these tests anywhere in the world, from Manhattan to Sub-Saharan Africa, empowering individuals to know more and worry less about their health. At inui™, we are excited to bring the diagnostic lab to areas with no laboratories or limited medical facilities.”
New test kit for quick, accurate and low-cost screening of diseases
A multidisciplinary team of researchers at the National University of Singapore (NUS) has developed a portable, easy-to-use device for quick and accurate screening of diseases. This versatile technology platform called enVision (enzyme-assisted nanocomplexes for visual identification of nucleic acids) can be designed to detect a wide range of diseases -- from emerging infectious diseases (e.g. Zika and Ebola) and high-prevalence infections (e.g. hepatitis, dengue, and malaria) to various types of cancers and genetic diseases.
enVision takes between 30 minutes to one hour to detect the presence of diseases, which is two to four times faster than existing infection diagnostics methods. In addition, each test kit costs under S$1 -- 100 times lower than the current cost of conducting similar tests.
"The enVision platform is extremely sensitive, accurate, fast, and low-cost. It works at room temperature and does not require heaters or special pumps, making it very portable. With this invention, tests can be done at the point-of-care, for instance in community clinics or hospital wards, so that disease monitoring or treatment can be administered in a timely manner to achieve better health outcomes," said team leader Assistant Professor Shao Huilin from the Biomedical Institute for Global Health Research and Technology (BIGHEART) and Department of Biomedical Engineering at NUS. Asst Prof Shao is also an investigator with the Institute of Molecular and Cell Biology (IMCB) under the Agency for Science, Technology and Research (A*STAR).
The research team used the human papillomavirus (HPV), the key cause of cervical cancer, as a clinical model to validate the performance of enVision. In comparison to the clinical gold standard, this novel technology has demonstrated superior sensitivity and specificity.
"enVision is not only able to accurately detect different subtypes of the same disease, it is also able to spot differences within a specific subtype of a given disease to identify previously undetectable infections," Asst Prof Shao added.
Clinical Chemistry
Establishment of a novel homogeneous nanoparticle-based assay for sensitive procalcitonin detection of ultra low-volume serum samples
Purpose: Sepsis is a potentially fatal systemic body infection with a significant mortality rate worldwide. Although C-reactive protein (CRP), interleukin-6 (IL-6), and procalcitonin (PCT) might be biomarkers for sepsis diagnosis, PCT is more sensitive and specific than CRP or IL-6. We aimed to establish an efficient immunoassay that precisely detects PCT in human serum for the early diagnosis of sepsis.
Materials and methods: We developed a novel amplified luminescent proximity homogeneous assay (AlphaLISA) for the quantitative detection of PCT in serum. In this assay, a pair of antibodies was used to capture PCT in serum and to form sandwich complexes after incubating for 15 minutes at 37°C.
Results: PCT concentrations were determined within a linear range of 0.016–100 ng/mL. The limit of detection was 18.6 pg/mL. The results demonstrate that the reproducibility, recovery, and specificity of this assay for PCT meet the requirements of clinical detection. The coefficient of determination (R2) between this method and commercially available enzyme-linked fluorescent assay (ELFA) kits was estimated to be 0.93045 in clinical serum testing.
Conclusion: The novel assay for PCT detection was robust with high sensitivity and a broad dynamic range. Compared with conventional heterogeneous detection methods such as ELISA, this assay measured the concentration of the homogeneous form of PCT and provided results that are more accurate within a shorter detection time. We expect that this novel method will be useful for the early screening and prognosis evaluation of patients with sepsis.
When Direct and Indirect Ion Selective Electrode Results Conflict
There are two methods for measuring serum electrolytes using ISE: direct and indirect. As the name suggests, with direct ISE the patient’s serum sample is brought into direct contact with the electrode surface and the activity of the relevant ion is measured in the plasma water of the serum.
Indirect ISE, on the other hand, involves diluting the patient’s serum with a buffer in the range of 1:16 to 1:34 before the sample comes in contact with the ISE membranes. This method then calculates the electrolyte concentration in the diluted sample by assuming that the original sample had a plasma water concentration of 93%. Indirect ISE analyzers use this calculation because electrolytes are distributed only in the aqueous phase of plasma, while dissolved solids—mostly proteins and lipids—typically make up the remaining 7% of a patient’s plasma volume.
However, many illnesses, such as diabetes, liver and kidney disorders, and alcoholism, can raise protein and lipid concentrations in the blood, causing hyperproteinemia and hyperlipidemia, respectively. These conditions do not impact direct ISE, but indirect ISE results depend on the content of solids in a sample because of the dilution step. When the volume of plasma solids increases this can lead to falsely low indirect ISE values for serum electrolytes, especially sodium—a phenomenon known as pseudohyponatremia.
Read the full article by clicking on the title above.
Molecular Genetics
Genomic study brings us closer to precision medicine for type 2 diabetes
Most patients diagnosed with type 2 diabetes are treated with a "one-size-fits-all" protocol that is not tailored to each person's physiology and may leave many cases inadequately managed. A new study by scientists at the Broad Institute of MIT and Harvard and Massachusetts General Hospital (MGH) indicates that inherited genetic changes may underlie the variability observed among patients in the clinic, with several pathophysiological processes potentially leading to high blood sugar and its resulting consequences.
By analyzing genomic data with a computational tool that incorporates genetic complexity, the researchers identified five distinct groups of DNA sites that appear to drive distinct forms of the illness in unique ways.
The work represents a first step toward using genetics to identify subtypes of type 2 diabetes, which could help physicians prescribe interventions aimed at the cause of the disease, rather than just the symptoms.
The study appears in PLOS Medicine.
"When treating type 2 diabetes, we have a dozen or so medications we can use, but after you start someone on the standard algorithm, it's primarily trial and error," said senior author Jose Florez, an endocrinologist at MGH, co-director of the Broad's Metabolism Program, and professor at Harvard Medical School. "We need a more granular approach that addresses the many different molecular processes leading to high blood sugar."
It's known that type 2 diabetes can be broadly grouped into cases driven either by the inability of pancreatic beta cells to make enough insulin, known as insulin deficiency, or by the inability of liver, muscle or fat tissues to use insulin properly, known as insulin resistance.
Building A Bridge From Direct-to-Consumer Genetic Tests To Reality
A recent op-ed by genetic counselor Laura Hercher illuminated a sticky situation in which more and more consumers find themselves. Matt Fender ordered a spit kit from direct-to-consumer (DTC) genetic testing company 23andMe, downloaded his raw data, and ran them through a third party service called Promethease, which can help consumers make sense of their raw data. Fender’s Promethease report highlighted a genetic variant in the raw data that, if truly present, would place him at very high risk to develop an early-onset form of Alzheimer disease and would alter the course of his life.
Fender found himself in a gap where thousands before him have fallen, and where even more will end up if the estimates that 100 million consumers will have DTC genetic testing by 2021 are correct. Namely, he had information in his hands that could be either accurate medical information or dead wrong. Why? At a consumer’s request, some DTC companies release raw genetic data that has not been verified under the umbrella of genetics ‘entertainment’ (or genutainment). This means that these raw data are not complete or ‘medical-grade’ genetic information; however, they can, and sometimes do, reveal serious and accurate medical information. Fender wanted to learn if his result was accurate, but he had a difficult time getting the confirmatory medical-grade test he needed because he had no personal or family history of this disease.
Health care providers, as a whole, do not have the time, training, or desire to wade through these lengthy reports to help consumers decipher if DTC test kits and raw data findings are accurate or not. And, importantly, insurance companies most often will not cover these consultations or repeat testing if, like Fender, the patient has no personal or family history of that disease. So, how do we throw down a line to consumers stuck in this abyss?
Since being blocked by the FDA from returning health information in 2013, some companies have worked with the agency on a process through which they can return some health information directly back to consumers. For example, 23andMe is again releasing the three common Jewish BRCA1 and BRCA2 variants (3 of thousands of pathogenic BRCA variants, also known as mutations) to consumers. They recommend that all consumers then repeat that testing through their health care provider in a medical-grade laboratory, which lands those consumers in the abyss. Until now.
Forward-thinking insurer Blue Shield of California has stepped up to the plate. Under the leadership of genetic counselor Stephanie Gandomi and Director of Enhanced Clinical Programs, Henry Garlich, Blueshield implemented a medical policy that covers confirmatory testing in a medical-grade laboratory for any insured who has received a positive Ashkenazi Jewish BRCA finding directly from 23andMe. Perhaps at some point in the future, they and other visionaries in the field will expand medical policies to include confirmatory testing for patients who learn of other potentially important genetic findings on their DTC raw data analysis.
Fertility
Sperm quality study updates advice for couples trying to conceive: Clinical trial suggests doctors should also change IVF protocol
Recent research from Li's and Wang's lab, published in the journal Molecular and Cellular Proteomics, upends conventional wisdom that abstaining between efforts to conceive can improve a couple's chances of success. The research team worked with almost 500 couples to test whether how long a couple waits between efforts to conceive could change their success rates.
"For years, men have usually been advised to limit sexual activity to increase the chances of pregnancy," said Li. "However, it's time to change our minds."
Some earlier studies had shown that semen produced shortly after a man's most recent ejaculation -- within three hours or so -- had faster and more motile sperm than if the man abstained for several days before ejaculating again. But it wasn't clear why the sperm changed or whether the changes affected fertility. So researchers set up a few side-by-side experiments to investigate.
They looked at individual subjects' semen after they had abstained for either several days or just an hour or two, comparing the volume of semen and the mobility of sperm. As had been observed earlier, the sperm from shorter abstinence periods moved faster.
Using a technique called mass spectrometry to look at the protein makeup of the samples, the team found some major molecular differences. The majority of the affected proteins were involved in cell adhesion, a function that sperm need in order to fuse with egg cells.
The team also observed changes to proteins involved in sperm motility and metabolism, especially in proteins that handle reactive oxygen species, a byproduct of cellular energy production. Although reactive oxygen species are needed for some normal sperm functions, having an excess can damage sperm's genetic material.
According to Li's results, the longer sperm exist, the more vulnerable they are to DNA damage by reactive oxygen, which could harm their ability to form a viable embryo.
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