diagnostic Archives

Asian Company Launches World’s First Diagnostic Test for Microbiome of the Mouth

Nov 27, 2023 | International Laboratory News, Laboratory Pathology, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing, Precision Medicine

Collected data could give healthcare providers and clinical laboratories a practical view of individuals’ oral microbiota and lead to new diagnostic assays

When people hear about microbiome research, they usually think of the study of gut bacteria which Dark Daily has covered extensively. However, this type of research is now expanding to include more microbiomes within the human body, including the oral microbiome—the microbiota living in the human mouth.

One example is coming from Genefitletics, a biotech company based in New Delhi, India. It recently launched ORAHYG, the first and only (they claim) at-home oral microbiome functional activity test available in Asia. The company is targeting the direct-to-consumer (DTC) testing market.

According to the Genefitletics website, the ORAHYG test can decode the root causes of:

The test can also aid in the early detection development of:

“Using oral microbial gene expression sequencing technology and its [machine learning] model, [Genefitletics] recently debuted its oral microbiome gene expression solution, which bridges the gap between dentistry and systemic inflammation,” ETHealthworld reported.

“The molecular insights from this test would give an unprecedented view of functions of the oral microbiome, their interaction with gut microbiome and impact on metabolic, cardiovascular, cognitive, skin, and autoimmune health,” BioSpectrum noted.

“Microbes, the planet Earth’s original inhabitants, have coevolved with humanity, carry out vital biological tasks inside the body, and fundamentally alter how we think about nutrition, medicine, cleanliness, and the environment,” Sushant Kumar (above), founder and CEO of Genefitletics, told the Economic Times. “This has sparked additional research over the past few years into the impact of the trillions of microorganisms that inhabit the human body on our health and diverted tons of funding into the microbiome field.” Clinical laboratories may eventually see an interest and demand for testing of the oral microbiome. (Photo copyright: ETHealthworld.)

Imbalanced Oral Microbiome Can Trigger Disease

The term microbiome refers to the tiny microorganisms that reside on and inside our bodies. A high colonization of these microorganisms—including bacteria, fungi, yeast, viruses, and protozoa—live in our mouths.

“Mouth is the second largest and second most diverse colonized site for microbiome with 770 species comprising 100 billion microbes residing there,” said Sushant Kumar, founder and CEO of Genefitletics, BioSpectrum reported. “Each place inside the mouth right from tongue, throat, saliva, and upper surface of mouth have a distinctive and unique microbiome ecosystem. An imbalanced oral microbiome is said to trigger onset and progression of type 2 diabetes, arthritis, heart diseases, and even dementia.”

The direct-to-consumer ORAHYG test uses a saliva sample taken either by a healthcare professional or an individual at home. That sample is then sequenced through Genefitletics’ gene sequencing platform and the resulting biological data set added to an informatics algorithm.

Genefitletics’ machine-learning platform next converts that information into a pre-symptomatic molecular signature that can predict whether an individual will develop a certain disease. Genefitletics then provides that person with therapeutic and nutritional solutions that can suppress the molecules that are causing the disease.

“The current industrial healthcare system is really a symptom care [system] and adopts a pharmaceutical approach to just make the symptoms more bearable,” Kumar told the Economic Times. “The system cannot decode the root cause to determine what makes people develop diseases.”

Helping People Better Understand their Health

Founded in 2019, Genefitletics was created to pioneer breakthrough discoveries in microbial science to promote better health and increase longevity in humans. The company hopes to unravel the potential of the oral microbiome to help people fend off illness and gain insight into their health.

“Microorganisms … perform critical biological functions inside the body and transform our approach towards nutrition, medicine, hygiene and environment,” Kumar told CNBC. “It is important to understand that an individual does not develop a chronic disease overnight.

“It starts with chronic inflammation which triggers pro-inflammatory molecular indications. Unfortunately, these molecular signatures are completely invisible and cannot be measured using traditional clinical grade tests or diagnostic investigations,” he added. “These molecular signatures occur due to alteration in gene expression of gut, oral, or vaginal microbiome and/or human genome. We have developed algorithms that help us in understanding these alterations way before the clinical symptoms kick in.”

Genefitletics plans to utilize individuals’ collected oral microbiome data to determine their specific nutritional shortcomings, and to develop personalized supplements to help people avoid disease.

The company also produces DTC kits that analyze gut and vaginal microbiomes as well as a test that is used to evaluate an infant’s microbiome.

“The startup wants to develop comparable models to forecast conditions like autism, PCOS [polycystic ovarian syndrome], IBD [Inflammatory bowel disease], Parkinson’s, chronic renal [kidney] disease, anxiety, depression, and obesity,” the Economic Times reported.

Time will tell whether the oral microbiome tests offered by this company prove to be clinically useful. Certainly Genefitletics hopes its ORAHYG test can eventually provide healthcare providers—including clinical laboratory professionals—with a useful view of the oral microbiome. The collected data might also help individuals become aware of pre-symptomatic conditions that make it possible for them to seek confirmation of the disease and early treatment by medical professionals.

—JP Schlingman

Related Information:

Genefitletics Brings Asia’s First Oral Microbiome Test ORAHYG

Let’s Focus on the Role of Microbiomes in Systemic Inflammation and Disease Development: Sushant Kumar, Genefitletics

Genefitletics Can Now Predict and Detect Chronic Diseases and Cancer

Healthtech Startup Genefitletics Raises Undisclosed Amount in Pre-seed Funding

Understanding Oral Microbiome Testing: What You Need to Know

Researchers Produce First Map of Human Proteome, Generating Promise for Developing Novel Medical Laboratory Tests and New Therapeutics

Aug 15, 2014 | Digital Pathology, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing

The human proteome map provides a catalog of proteins expressed in nondiseased issues and organs to use as baseline in understanding changes that occur in disease

Given the growing importance of proteins in medical laboratory testing, pathologists will want to know about a major milestone recently achieved in this field. Researchers have announced that drafts of the complete human proteome have been released to the public.

Experts are comparing this to the first complete map of the human genome that was made public in 2000. Clinical laboratory managers and pathologists know how the availability of this information provided the foundation for rapid advances in understanding different aspects involving DNA and RNA.
(more…)

Anticipating the Digital Medicine Revolution, Scripps Doctor Prescribes Smartphone Apps as Frequently as Medications

May 17, 2013 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology

Pathologists will want to engage with physicians as wireless devices and smartphone apps make it possible to maintain continuous surveillance of the body

Pathologists might want to borrow a page from a tech-savvy doctor who was voted the “Most Influential Physician Executive” in 2012. A cardiologist, this physician says he now prescribes mobile applications for his patients almost as frequently as he prescribes therapeutic drugs.

Many clinical laboratory managers will recognize the name of Eric Topol, M.D., who is the Director of the Scripps Translational Science Institute, Professor of Genomics at the Scripps Research Institute, and Chief Academic Officer at Scripps Health, all located in La Jolla, California. Topol has a passion for wireless medical technology. Moreover, he is nationally recognized as a wireless medical technology trailblazer, as well as for his medical expertise.

In fact, in one news clip, NBC News touts him as the nation’s foremost expert in the explosion of wireless medicine. Topol was also selected by GQ Magazine in 2009 as one of the nation’s 12 “Rock Stars of Science.” (more…)

Expanding Knowledge about the Human Microbiome Will Lead to New Clinical Pathology Laboratory Tests

Jul 7, 2010 | Laboratory News, Laboratory Pathology

With $175 Million in Funding, Human Microbiome Project is Making Rapid Progress

Research into the human microbiome is expected to trigger development of new diagnostic tests that will be offered by clinical pathology laboratories. That’s because the organisms that live on us and in us are as unique to individuals as their DNA, and scientists believe these microbes may be just as important to health. Which microbes and how much they matter to the host’s health are the questions a consortium of researchers involved in the Human Microbiome Project (HMP) hope to answer.

This five-year, $157-million project, funded by the National Institutes of Health, will sequence and classify 900 microbes believed to play a role in human health. Analysis of the sequences of the first 178 microbes, which was published in the May 21 issue of Science, held some surprises, particularly in regard to the extent and complexity of microbial diversity. About 90% of their DNA was previously unknown. The study also identified novel genes and proteins that contribute to human health and disease.

(more…)

Pathologists Take Note: C. Craig Venter Just Created the First Synthetic Life Form

Jun 4, 2010 | Laboratory News, Laboratory Pathology

Milestone achievement may lead to more sophisticated clinical laboratory tests

Now science can create synthetic life forms and J. Craig Venter, Ph.D., is the first to do it. The landmark feat, which involved building the genome of a bacterium from scratch and incorporating it into a cell, “paves the way for designer organisms that are built rather than evolved,” noted the author of an article in guardian.co.uk.

J. Craig Venter, Ph.D., best known to pathologists and clinical laboratory scientists for his role in sequencing the first human genome, achieved the feat at the J. Craig Venter Institute in Rockville, Maryland. Venter and his team synthesized the 1.08 million base pair chromosome of a modified Mycoplasma mycoides genome. The synthetic cell, called Mycoplasma mycoides JCVI-syn1.0, is proof of the principle that genomes can be designed in the computer, chemically made in the laboratory, and transplanted into a recipient cell to produce a new self-replicating cell controlled by the synthetic genome. The experiment demonstrates how fast genetic technologies are advancing.