The First Step in Market-Sizing the Molecular Point of Care Market: Defining What it is.

To establish a market size and forecast for molecular point of care systems, it’s necessary to understand what it is that is being measured. If a market for every dollar earned by selling any system that “could be used” in molecular point of care was established, the market would be much larger and have much more potential growth, possibly. But such a market definition would have little use to the countless new innovators who would like to compete with the GeneXpert, Cobas Liat or BioFire. This is the undertaking of Kalorama Information’s six editions of The Market and Potential for Molecular Point of Care. We published our first edition in 2013. The most recent edition was published one decade later, this January.

Kalorama Information defines Molecular Point of Care or mPOC devices as those that run PCR or other DNA and RNA testing on a portable device. Features include:

• DNA or RNA test technology
• Small footprint and reasonably portable
• Result time fast enough for office visit or bedside consultation
• Use possible outside of a reference lab
• Uses cartridges
• Limited or no sample preparation
• Is either running CLIA-waived tests or moderate complexity tests with potential for CLIA-waiver approval.
• While some mPOC systems may be used in labs that find their speed beneficial, that is not always their one purpose.

A much larger market can be estimated for molecular systems that can be brought near patient, but which do not meet a true point of care criteria. This market is about $8 billion, however near patient designation includes tests that could be several hours in turnaround and systems that are not usually marketed to physician offices and clinics, and may not have a reasonable chance of a CLIA-waiver in the forecast period. mPOC – tests with a quick turnaround, low operator training, CLIA-waived or reasonable chance of CLIA waiver in the near term.

Near Patient on the other hand is defined as tests with a moderate or high complexity yet performed on a near-patient instrument system, turnaround of several hours, not expected for CLIA-waiver within 5 year forecast.

Molecular point of care testing is also known as near-patient testing, or rapid PCR testing. POC diagnostics are preferred in certain episodes of care for shorter turnaround time or time to results when care implementation or triage is needed rapidly. The usability features of POC tests help enable rapid performance, but also expand their applicability across care settings. Key features of POC tests, including molecular POC tests, include simple results interpretation and integration of test procedures that minimize hands-on time and risk of user error. In low-healthcare resource areas of the developing world, POC tests are often preferred as they can be completed outside of laboratory settings, without lab infrastructure that is often difficult to access, and they can be conducted by people with little to no laboratory training. Lastly, POC tests find some preferential use in healthcare as a source of billing revenue otherwise claimed by independent labs.

Examples of POC settings include the following:

• Decentralized hospital labs or testing points found in emergency departments (ED), operating rooms (OR), intensive care units (ICUs) and other patient wards or hospital departments

• Bedside in a hospital using a portable device

• Labs or testing workstations at physician offices, physician practices or outpatient clinics such as rural health clinics, community clinics, public health clinics, student health clinics, sexual health clinics, retail clinics and other specialty clinics

• Small hospitals, community health posts, mobile clinics and field screening sites in the developing world without access to clinical lab infrastructure and where screening and other testing is performed largely with POCT products

• Ambulatory surgery centers

• Pharmacies

• Nursing home, hospice care center, long-term care facility, or even In-home or within the patient residence (performed by the patient or visiting medical professional)

• Workplace

• Military locations

• Mobile Laboratories and clinics

New Systems and Menu Expansion
In addition to the launch of new systems, other recently added tests on molecular point-of-care systems are a factor boosting markets. These are detailed below:

Mesa Biotech Strep A Approval
Mesa Biotech, developers of an affordable, easy to use, handheld testing platform for infectious disease diagnosis, today announced it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its Accula Strep A test. The Strep A cassette, for the molecular detection of Group A Streptococcus bacterial nucleic acid by rapid PCR, is cleared for diagnosing both children and adults and provides laboratory quality results in 30 minutes at the point of care (POC).

Accula Strep A is the third molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, following the company’s commercially available tests for Flu A/Flu B and RSV. In addition, the company received Emergency Use Authorization (EUA) for its SARS-CoV-2 cassette earlier this year. The ergonomically designed, simple to use Accula test, fits in the palm of your hand and is visually read, using reverse transcription-polymerase chain reaction (RT-PCR) technology to detect Strep A via throat, nasal or nasopharyngeal swab samples.

“With the addition of Strep A, we continue to deliver on our promise of bringing rapid, molecular diagnostics to the point of need,” said Bruce Cary, Ph.D, Co-founder and Chief Scientific Officer, Mesa Biotech, Inc. “The current pandemic has accentuated the need for PCR testing at the point of care and we are excited to be spearheading developments in this area.”

Group A streptococcus (GAS) is the most common bacterial cause of acute pharyngitis, an inflammation of the pharynx causing a sore throat and accounts for 15 to 30 percent of cases in children and 5 to 20 percent of cases in adults.1 It is estimated that 616 million people worldwide has a pharyngitis from a GAS infection annually and more than 18 million develop a severe GAS infection2. According to Pediatrics, GAS is easily and frequently spread among families, school-aged children and other close contacts via respiratory secretions, and infection peaks in the late winter and early spring.

Combination Tests Enter Market: SARS-CoV-2, Flu A, Flu B, and RSV
Cepheid received Emergency Use Authorization from the U.S. FDA for its next-generation test to support the global fight against COVID-19 during the upcoming respiratory virus season. The test can provide rapid detection of the current coronavirus SARS-CoV-2 in as soon as 25 minutes for positive results* and provide results for all four pathogens in just 36 minutes with less than a minute of hands-on time. Cepheid later introduced combination tests which offer COVID, flu, and RSV. The BioFire RP2.1 Panel (EUA) uses a syndromic approach to accurately detect and identify the pathogens most commonly associated with respiratory infections. The BioFire RP2.1 Panel (EUA) offers a run time of about 45 minutes, enabling high efficiency and throughput on the BioFire FilmArray 2.0 and the BioFire FilmArray Torch Systems. Rapid respiratory PCR test results may enable better-informed diagnosis and treatment of patients. Quick turnaround on a broad menu of pathogens may also help clinicians make vital decisions regarding admission, isolation, cohorting, and additional diagnostic testing.

STI Continues to Be a Growth Area
The US Food and Drug Administration clearance of Binx Health’s Binx io instrument and assay for chlamydia and gonorrhea was significant. In 2020, Randox Laboratories received CE-IVD marking for its STI test on the Vivalytic platform; to diagnose Chlamydia trachomatis; Neisseria gonorrhoeae; Trichomonas vaginalis; Mycoplasma genitalium; Treponema pallidum; herpes simplex virus 1; herpes simplex virus 2; Haemophilus ducreyl; Mycoplasm hominis; and Ureaplasma urealyticum.

There are numerous lab-based CT/NG tests currently commercially available and under development, but the most similar test to Binx’s might be the Cepheid GeneXpert CT/NG. The Binx test takes 30 minutes while the Cepheid test takes 90 minutes. Other rapid point-of-care molecular test systems cleared by the FDA and CLIA waived – including the Roche Liat, Abbott ID Now, and Mesa Biotech Accula – to date do not offer CT/NG testing. Cue Health has announced that it is addressing this segment.

Deals, Investment in mPOC Systems
Kalorama had noted a slowdown in new investments in molecular point of care since systems were first introduced in 2013, but that appears to have turned around. Investors are interested in new types of devices expanding menus, particularly due to COVID-19. The report contains information and provides a selection of recent funding deals, and the following also illustrate some examples.

Thermo Acquires Mesa Biotech
In January 2021, Thermo announced that it was acquiring Mesa Biotech for $450M in cash. Mesa Biotech is a molecular diagnostic company that has developed an affordable, sample-to-answer molecular testing platform designed for point-of-care (POC) infectious disease diagnosis. In early 2020, Mesa announced the addition of the new coronavirus (SARS-CoV-2) to its active influenza clinical trial in China. The coronavirus test development and clinical trial was in collaboration with Dr. Wang Guangfa, head of the Department of Pulmonary Medicine at Peking University First Hospital in Beijing. In April 2020, the company was making 40,000 tests per month.

Their technology development started at Los Alamos National Lab supported by NIH grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program. The company has focused on technology suited for emergency defense and rapid deployment for SARS, Ebola and other emerging infectious diseases. Mesa’s platform was specifically designed for use outside the lab to enable rapid responses to global pandemics, such as COVID-19.