IVD Says: “Can We Just Focus on What’s Important Here!”

OK, we are paraphrasing here. But if you look at the recent approvals, you see in vitro diagnostic test makers saying it, adopting an approach of let’s test for what can best help providers. Don’t get their intentions wrong, they plan to sell the big comprehensive tests too. But what they are pushing is testing for the important.

Case in point: Inflammatix, more or less is saying “We got to stop thinking about sepsis as a disease.” We have to stop ruling it “in,” or ruling it “out.” Now I am paraphrasing, but this is the war-weary cry of many providers which has been picked up by test makers. One of them is Inflammatix.

They just obtained FDA approval for their TriVerity. It’s a triage device. It trys to define the patient’s sepsis rather than an arbitrary “rule in- rule out” https://www.insideprecisionmedicine.com/topics/molecular-dx/inflammatix-scores-fda-approval-for-precision-infection-test/

At the same time, Qiagen gets the nod for its QIAstat DX Mini Gastrointestinal Panel. Similar message, though in this case it is ruling in and ruling out disease(s). We can test for everything that could be wrong with a patient. If they are really sick, sure – we’ve got a system for that. But for now, here’s five diseases you need to think about.

The Qiagen mini product covers five causes of gastrointestinal illness that are recommended by the Infectious Diseases Society of America (IDSA): the bacteria Campylobacter, Salmonella, Shiga-like toxin E.Coli (STEC) and Shigella, along with Norovirus, one of the most common causes of gastrointestinal infection and an important target during the winter season.

It’s not minimalism, it’s maximization of benefit to medical practice. Sepsis is a proven killer, as much as 2% of hospitalizations see it, and much more of ICU cases. And yet there are myriad definitions and provider-specific practices around the condition. So the idea of TriVerity’s system is to tell doctors how sick a patient is likely to get, and if it might be related to other diseases (say pneumonia).

Says Inflammatix:

“The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’ But sepsis is a syndrome, not a disease, and its definition keeps changing. We therefore designed TriVerity to look at its clinically actionable core elements: (1) does this patient have an infection, and (2) how sick are they likely to become?”

How does it work? TriVerity is a rapid blood test that measures the expression levels of 29 genes associated with the host immune response to infection. It uses validated algorithms developed with artificial intelligence and machine learning to interpret this data into three scores indicating the likelihood of bacterial infection, viral infection, and severe illness, defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days.

For Qiagen, the idea is: test for the horses, then the zebras.

If there’s sick patients, very sick patients, and more causes might be suspected, sure elevate that patient to the comprehensive panel that we make. To some degree these are two different test markets, and this product launch plays into that. In the end of the day they are related of course. These pathogens are commonly referred to as enteric pathogens or gastrointestinal pathogens. They are a major concern for public health agencies, including the CDC and WHO, due to their high incidence and potential for outbreaks. Norovirus, in particular, is one of the most common causes of viral gastroenteritis worldwide, especially during the winter months, leading to millions of cases annually In the U.S., the CDC estimates that:

STEC infections, including E. coli O157, cause about 265,000 cases each year, with around 3,600 hospitalizations.

Norovirus causes around 19–21 million cases of vomiting and diarrhea each year.

Salmonella causes about 1.35 million infections, leading to 26,500 hospitalizations and 420 deaths annually.

Campylobacter results in 1.5 million infections per year.

Shigella leads to 450,000 cases annually.

Is it just these two companies? Of course not, all of IVD to a degree is shaping this way. Of course there is bioMerieux’s sore throat panel, released last year, which provides a CLIA-waived answer to “what is my patient’s sore throat?” which in line with the only-what’s-important concept. BIOFIRE SPOTFIRE Respiratory Sore Throat RST Panel Information Sheet – FDA Cleared – CLIA Waived.pdf The company said the launch of the system was successful.

IVD has to do better than Pharma with Gen Z. A marketing survey said that only 43% of Gen Z believe pharma companies care about Gen Z. And just over half (51%) think pharma companies communicate well with them. – (Marketing & PharmaAfter Covid and health view shifts, Gen Z opens door for pharma communications: survey) This type of “what’s important only” approach can help the industry with that.

Siemens Healthineers and Football: Siemens Healthineers has a heart attack prognostication test that can help everyone, even football fans, find out if they are in trouble. https://www.siemens-healthineers.com/en-us/press-room/press-releases/heart-attacks-data-press-release Yes, BTW you read it right – the company found that most people would stay at a football game even if they had heart attack symptoms. (Which is something to work on, for sure).

Liver Disease Needs a Buddy: Check out our previous webinar participant Robert LaCroix’s of LTC-LLC post on Linked IN RE- liver disease. His main point: Cardiac disease has HDL cholesterol to determine who may be at risk – it’s an abnormality that you use to help the detection process. What of Liver disease? Liver disease needs a warning marker, not just a marker when disease is present.

Need market research, EYE ON IVD created and endorsed research is available. Go to IVD market experts not people who are making reports in 1000 fields at the same time. We’ve got a bunch of products available in our research shop.