How a diagnostic testing insider is addressing concerns.

10 minute read.

     

 

So, here’s the deal.   My personal and professional worlds are colliding!

Let me explain. …at Market Ready Rx, we support companies who develop pathogen tests– like the COVID19 test.  We conduct market studies to help our clients understand customer behavior before they launch diagnostic tests to hospitals and labs.   During the past year, my team and I have interviewed more than 75 Hospital Microbiologists and Family Practice Nurses and Clinicians worldwide to better understand how these medical professionals utilize Influenza, respiratory and other infectious disease tests to reduce the spread of infection.   We have been speaking with healthcare practitioners on the front lines who think daily about ways to prevent outbreaks and pandemics, and, more importantly, how to identify novel pathogens– like the Coronavirus.

When the China Coronavirus cases began to climb exponentially in January –the voices of these interviews rang in my head.    I had SERIOUS concerns.

 

The questions continued to mount:

1. Have we aligned on the RIGHT test globally so we can capture consistent data from country to country?  Are we standardized in how we measure results around the world?

MAYBE. The truth was the test defined by the WHO was NOT the test ultimately released in the US by the CDC.  The CDC’s COVID19 had been published a week apart from WHO when scientists around the world were racing to identify a test quickly for the looming pandemic expected to arrive in the US.  The reason the CDC used  a different test than the WHO has yet to be revealed.   Responsibly, the WHO has posted  Molecular Assays to diagnose 2019nCoV  on their website and lists the current methods used globally with links to primers and protocols.

My Take:  As long as there is scientific collaboration between countries and transparency on the testing methods, as the WHO has initiated, the varying testing methods are fine for now.  A global standardization effort can take place AFTER the pandemic has passed.  Diagnostic professionals are familiar with  many diagnostic tests that are not globally standardized and are serving patients globally today. 

 

 

2.  Were the first COVID19 tests performed in China sensitive enough to detect the asymptomatic cases?

MAYBE. While we don’t know how sensitive the first tests were in detecting patients with low levels of virus who didn’t have symptoms, we DO know that self- quarantining when exposed to a COVID19 positive patient has mitigated this possible gap in testing and reduced spread of the virus.   Let’s be practical in recalling that early in the crisis China had to identify and sequence the virus, so developing a perfect test was not a realistic option.  Speed was an important first step.

Regardless, to  help answer this question,  on March 8^th  a German study was published and summarized by  STAT NEWs where they reported-

“…. researchers found very high levels of virus emitted from the throat of patients from the earliest point in their illness —when people are generally still going about their daily routines. Viral shedding dropped after day 5 in all but two of the patients, who had more serious illness. The two, who developed early signs of pneumonia, continued to shed high levels of virus from the throat until about day 10 or 11.”

My Take:  COVID19 Testing appears to be appropriately catching asymptomatic patients.  We now need to make COVID19 testing widely available!

 

3. Do we have capacity to test the number of infected people which will be needed in the US if we anticipate symptomatic patients to grow exponentially … as they have in Italy?

NO. Initially there was a misstep with the CDC distributing test kit reagents and protocols to State Public Health labs which the local labs were not able to validate due to a negative control testing positive.Additionally, Public Health labs don’t have testing capacity - as they don’t have the experience of large national labs to manage millions of patient samples logistically from collection to reporting rapidly.   Further, the Atlantic conducted a study polling all US State labs to understand their true testing capacity.   They found that although testing varies from state to state, California has the largest capacity for 6000- 7400 patients a day… not enough testing

My Take:  To be truly able to distinguish TRUE coronavirus positives (vs. influenza or other respiratory issue) we need a broad screening test that can test any suspected coronavirus symptoms.   This requires large population screening. 

The good news is Diagnostic testing is emerging from commercial testing labs

The high-complexity CLIA-certified labs were authorized this week to immediately perform tests they've developed and validated for the SARS-CoV2 coronavirus while they are pursuing emergency use authorization with the FDA.  They include:

• Lab Corp of America Labs
• Quest Diagnostic Labs
• Mayo Clinic
• OPKO Health, a subsidiary Bioreference Laboratories, is offering a public drive-through testing facility in New Rochelle, NY, with additional satellite sites to be set up next week enabling the processing of up to 5,000 tests/day.

**Others may have been authorized since this writing

 

4. What about other diagnostic companies with PCr Automated Platform approvals so local Hospitals can begin to test?

 MORE GOOD NEWS.  This week the FDA granted the following industry leading companies’ authorization to rollout tests to the market (under emergency use authorization) to enable labs nationwide to introduce the test on existing PCR instruments across the country for greater capacity in a city in high complexity labs.

The following Companies are currently in the process of rolling out their tests

• Roche Diagnostics cobas 6800 is for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the clinical and epidemiological criteria for testing and can be used with Roche's fully automated Cobas 6800 and Cobas 8800 systems.
• Becton Dickenson BD Max with CerTest Biotec - the Spanish developer of the COVID 19 CEmark test.
• Luminex Announcedthat four independent laboratories have validated laboratory-developed tests (LDTs) using their ARIES System. It plans to file for an Emergency Use Authorization for ARIES SARS-CoV-2 next month.
• Genmark The company also announced theinitial global shipments of ePlex Research Use Only (RUO) test kits designed to detect the SARS-CoV-2 virus. This information can be used to support submission of an Emergency Use Authorization to the FDA.
• QIAGEN Announced $598K in funding from BARDA to support accelerated development of its QIAstat-Dx test kit for identifying the genetic material of SARS-CoV-2.

My Take:  I predict the industry be in full commercial routine testing by the end of March (following validation by local labs) with full volume capacity ramped up by mid to late April.

 

5.  With so much information coming at us, where is the best source of information?

During the past year, we’ve interviewed laboratory professionals globally who manage patients worldwide in respiratory disease, influenza and various infectious pathogens.  We’ve learned the following from these studies…

• Laboratory professional in Microbiology and ID are deeply concerned about outbreaks and are monitoring the situation and have data at their disposal about the epidemiology in the community and hospitals.
• Levels of preparedness vary from country to country with no perfect infection control outbreak solution- we all have a lot to learn but now is not the time to question.
• Epidemiologists globally are our guides to help us predict what is to come- we should follow their expert advice
• There is still a lot we don’t know about novel virus emerging, and other resistant pathogens- these experts are at the cutting edge.

My Take:  Let’s lean on Infectious Disease Experts to guide us through this.  Encourage friends and family to stay current based on experts like the CDC and  WHO .

 

6. How can you help educate your families and friends when panic arises?

I get it.  On the personal front this week I was shocked to arrive at my local Whole Foods, CVS and Costco to find empty shelves and mass shortages (hand sanitizer, paper goods etc.).   AND yesterday emails flooded my inbox cancelling sporting events, special celebrations.  Even my exercise classes are restricted to smaller groups to allow for social distancing.    This shift in every facet of our daily routine is incredibly stressful.

My Take:  Let’s use this opportunity to get to know our neighbors in small gatherings. We need to follow instructions carefully from our local health and local government officials being guided by experts in this area.   Have some understanding that the communication may be erratic and change day to day, but everyone is doing the best they can.

… and Remember Four S’s

• Sanitize – 20 seconds of hand washing as frequently as practical, don’t touch your face with dirty hands.   Alcohol kills the virus so sanitize cooking and eating areas. see Journal of Hospital Infection January 31,2020
• Separate   -   Social separation of six feet in public places will reduce chance of viral droplets reaching you from a possible infected person
• Self Contain if Symptoms –  If you have symptoms such as fever, cough, malaise and stay home and Self contain.  Call your doctor to see if you qualify for a Covid19 test* and if positive stay home (Quarantine for 14 days). *Testing is still being controlled by our Health care professionals.  Be sure to contact your local hospital ER or Health practitioner should you feel sick.
• Solidarity – We’re in this together and we need to work with our global colleagues, friends and family to get to the other side of this.

 

Based on the epidemiological modeling with learnings from China we can  predict the number of cases will likely peak in the US in the coming weeks.

Let’s prepare NOW with small neighborhood gatherings and enjoy long walks outside in your neighborhood.  Perhaps even enjoy working from home with your loved ones!

Contact me today to share your thoughts on this article or learn more about how we can support your personalized diagnostic product commercialization contact me at marketreadyrx.